Immunizations for Adults With HIV

Immunizations for Adults With HIV

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

RECOMMENDATION
Immunizations
  • Clinicians should follow the recommendations for routine vaccination of adults with HIV issued by the Centers for Disease Control and Prevention, the National Institutes of Health, the HIV Medicine Association, and the Infectious Disease Society of America, as presented here. (A2)

Purpose of This Document

This compendium of immunization recommendations for adults (≥18 years) with HIV was compiled by the New York State (NYS) Department of Health (DOH) AIDS Institute (AI) to assist clinical practitioners in NYS who provide primary care to adults with HIV. The goal is to present in one easy-to-use document all of the routine vaccinations recommended for adults with HIV by the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), HIV Medicine Association (HIVMA) [AIDSinfo 2019], and the Infectious Disease Society of America [Rubin, et al. 2014]. The European AIDS Clinical Society guidelines were also consulted [EACS 2019]. Where a recommendation differs from these source documents, the NYSDOH AI rationale is provided. This document integrates current evidence-based clinical recommendations into the healthcare-related implementation strategies of the Ending the Epidemic initiative, which seeks to end the AIDS epidemic in NYS by the end of 2020.

Immunizations against infectious diseases are a particularly important component of care for individuals with HIV. Immunodeficiency reduces natural defenses to vaccine-preventable diseases in people with HIV and places them at increased risk for disease and for severe disease [Crum-Cianflone and Wallace 2014; Rubin, et al. 2014]. However, there is concern that patients with HIV-associated immunodeficiency may not be able to mount and maintain an appropriate immune response to vaccines and may be harmed by live virus vaccines. The strength of the immune response may be lower in patients with more advanced HIV, especially among those with CD4 counts <200 cells/mm3 and/or HIV viral load >200 copies/mL, and shorter in duration than in adults without HIV [Crum-Cianflone and Wallace 2014]. Immunogenicity, vaccine response monitoring, and requirements for additional booster doses for patients with HIV are discussed on pages for individual vaccines.

Development of this document: This reference was compiled by the NYSDOH AI Clinical Guidelines Program, which is a collaborative effort between the NYSDOH AI Office of the Medical Director and the Johns Hopkins University School of Medicine, Division of Infectious Diseases.

The goal of the Clinical Guidelines Program, established in 1986, is to develop and disseminate evidence-based, state-of-the-art clinical practice guidelines to improve the quality of care throughout NYS for people with HIV, hepatitis C virus infections, or sexually transmitted infections; people with substance use issues; and members of the LGBTQ community. NYSDOH AI guidelines are developed by committees of clinical experts through a consensus-driven process.

The NYSDOH AI Medical Care Criteria Committee is charged with developing evidence-based clinical recommendations for clinicians in NYS who treat adults with HIV. The recommendations in this document, with the exception of one, are the same as those of the CDC/NIH/HIVMA guidelines. This document also discusses published literature related to specific vaccines and the rationale for recommendations for which there is no consensus among the referenced guidelines, no evidence specific to patients with HIV, or new data have been published.

References

AIDSinfo. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2019 https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/whats-new-guidelines [accessed 2019 Nov 26]

Crum-Cianflone NF, Wallace MR. Vaccination in HIV-infected adults. AIDS Patient Care STDS 2014;28(8):397-410. [PMID: 25029589]

EACS. European AIDS Clinical Society guidelines version 10.0. 2019 https://www.eacsociety.org/files/2019_guidelines-10.0_final.pdf [accessed 2019 Nov 26]

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Considerations and Contraindications

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

The tables and accompanying discussion in this section compile recommendations from the Centers for Disease Control and Prevention (CDC), National Institutes of Health, and HIV Medicine Association guidelines on immunization of adults with HIV who are not pregnant, along with vaccination schedules, clinical comments, and sources. The only recommendation in this guideline that was developed by the HIV Clinical Guidelines Program Medical Care Criteria Committee is in the section on zoster vaccination. Table 21 compiles all immunization recommendations into one printable table.

Inactivated vaccines are generally considered safe, although data are insufficient to rule out rare adverse effects [Rubin, et al. 2014; Ezeanolue, et al. 2019]. Live, attenuated vaccines are contraindicated for patients with CD4 counts <200 cells/mm3, because of the risk of severe reactions in individuals who are immunosuppressed [Davis, et al. 1977; Redfield, et al. 1987; CDC 1985, 1996]. For patients with HIV and CD4 counts ≥200 cells/mm3, inactivated forms of vaccines such as those for polio, influenza, typhoid, and zoster are preferred over the live vaccine options. Live, attenuated vaccines should be administered only when an inactivated version does not exist and the risk of the disease clearly outweighs the theoretical risk of vaccination.

KEY POINT: USE OF LIVE, ATTENUATED VACCINES
  • Patients with CD4 count <200 cells/mm3: The following live, attenuated vaccines are contraindicated: Bacillus Calmette-Guérin; measles, mumps, rubella; oral typhoid; rotavirus*; varicella; yellow fever; zoster.
  • Patients with CD4 count ≥200 cells/mm3Use live, attenuated vaccines only if an inactivated alternative is not available and the risk of disease is greater than the risk of vaccination.

*Patient education: Patients with HIV should avoid handling diapers of infants vaccinated against rotavirus in the previous 4 weeks, and all household members should wash their hands after changing diapers of an infant recently vaccinated against rotavirus.

Transient increases in viral load and decreases in CD4 cell count caused by immune system activation have been described after vaccination in patients with HIV in some older studies [Rey, et al. 2000; Kolber, et al. 2002]. The changes are less likely to occur in patients taking antiretroviral therapy (ART) and have not been found to have long-term negative effects [Sullivan, et al. 2000; Rubin, et al. 2014].

KEY POINTS
  • In people older than 5 years with HIV, effective ART is defined as ART taken for ≥6 months, with a CD4 percentage ≥15% and a CD4 count ≥200 cells/mm3 for ≥6 months [McLean, et al. 2013].
  • Viral suppression is defined as an HIV viral load <200 copies/mL.

Clinicians should advise their patients with HIV that family members, close contacts, and other household members should receive all age-appropriate vaccinations, including an annual influenza vaccine, to reduce the patients’ exposure to vaccine-preventable diseases [Fiore, et al. 2011; Rubin, et al. 2014; Grohskopf, et al. 2019]. Live, attenuated virus vaccines may be safely administered to close contacts of persons with HIV, with specific precautions for varicella and rotavirus vaccines. Transmission of live, attenuated virus after vaccination is rare [Rubin, et al. 2014]. However, patients with HIV who lack varicella immunity are advised to avoid direct contact with persons who develop a rash after varicella or zoster vaccination and should not handle diapers of an infant recently vaccinated against rotavirus [Marin, et al. 2007; Cortese and Parashar 2009; Fiore, et al. 2011; Rubin, et al. 2014].

Tables 7 through 20 (for each vaccine listed) present the recommended immunizations for adults with HIV, followed by discussion of each. For complete vaccination recommendations, see the CDC Immunization Schedules and the vaccine manufacturers’ package inserts.

How to File a Claim With the Vaccine Injury Compensation Program
  • Tel: 1-800-338-2382
  • Website: hrsa.gov/vaccinecompensation
  • Address to file a claim: US Court of Federal Claims, 717 Madison Place, NW, Washington DC 20005
References

CDC. Disseminated Mycobacterium bovis infection from BCG vaccination of a patient with acquired immunodeficiency syndrome. MMWR Morb Mortal Wkly Rep 1985;34(16):227-228. [PMID: 3920493]

CDC. Measles pneumonitis following measles-mumps-rubella vaccination of a patient with HIV infection, 1993. MMWR Morb Mortal Wkly Rep 1996;45(28):603-606. [PMID: 8676852]

Cortese MM, Parashar UD. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2009;58(Rr-2):1-25. [PMID: 19194371]

Davis LE, Bodian D, Price D, et al. Chronic progressive poliomyelitis secondary to vaccination of an immunodeficient child. N Engl J Med 1977;297(5):241-245. [PMID: 195206]

Ezeanolue E, Harriman K, Hunter P, et al. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP). 2019 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf [accessed 2019 Dec 2]

Fiore AE, Fry A, Shay D, et al. Antiviral agents for the treatment and chemoprophylaxis of influenza — recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(1):1-24. [PMID: 21248682]

Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and control of seasonal influenza with caccines: Recommendations of the Advisory Committee on Immunization Practices – United States, 2019-20 influenza season. MMWR Recomm Rep 2019;68(3):1-21. [PMID: 31441906]

Kolber MA, Gabr AH, De La Rosa A, et al. Genotypic analysis of plasma HIV-1 RNA after influenza vaccination of patients with previously undetectable viral loads. AIDS 2002;16(4):537-542. [PMID: 11872996]

Marin M, Guris D, Chaves SS, et al. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56(Rr-4):1-40. [PMID: 17585291]

McLean HQ, Fiebelkorn AP, Temte JL, et al. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2013;62(Rr-04):1-34. [PMID: 23760231]

Redfield RR, Wright DC, James WD, et al. Disseminated vaccinia in a military recruit with human immunodeficiency virus (HIV) disease. N Engl J Med 1987;316(11):673-676. [PMID: 3821799]

Rey D, Krantz V, Partisani M, et al. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. Effects on HIV-1 viral load. Vaccine 2000;18(13):1161-1165. [PMID: 10649616]

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Sullivan PS, Hanson DL, Dworkin MS, et al. Effect of influenza vaccination on disease progression among HIV-infected persons. AIDS 2000;14(17):2781-2785. [PMID: 11125897]

COVID-19 Vaccine for Adults With HIV

Lead author: Christine Kerr, MD; January 12, 2022
Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
CommitteeMedical Care Criteria Committee

RECOMMENDATIONS
COVID-19 Vaccine for Adults With HIV
  • Clinicians should recommend COVID-19 vaccination for all people ≥5 years old, including those with HIV; vaccines to prevent COVID-19 have either been fully approved by the U.S. Food and Drug Administration (FDA) or approved through an FDA Emergency Use Authorization (EUA). (A1)
  • Clinicians should provide supplemental vaccination (“third dose”) to all people with HIV who are immunocompromised, including patients with active viremia or a CD4 count ≤200 cells/mm3 and patients who met one of those criteria at the time of initial vaccination. (A2)
  • Clinicians should provide a booster vaccination to all people ≥12 years old, including those with HIV. (A2)

The Pfizer-BioNTech COVID-19 vaccine received full FDA approval for use in adults on August 23, 2021. The Moderna and Johnson & Johnson (Janssen) vaccines are available through an FDA EUA; both companies have applied for full FDA approval. For more information, see:

Immunizations against infectious diseases are a particularly important component of care for individuals with HIV. Immunodeficiency reduces natural defenses to vaccine-preventable diseases in people with HIV and places them at increased risk of infection and severe disease [Crum-Cianflone NF and Wallace 2014; Rubin, et al. 2014]. However, there is concern that patients with HIV-associated immunodeficiency may not mount and maintain an appropriate immune response to vaccines and may be harmed by live virus vaccines. The strength of the immune response may be lower in patients with more advanced HIV, especially among those with CD4 counts <200 cells/mm3 and/or HIV viral load >200 copies/mL, and shorter in duration than in adults without HIV [Crum-Cianflone NF and Wallace 2014]. Immunogenicity, vaccine response monitoring, and requirements for additional booster doses for patients with HIV are discussed on pages for individual vaccines in this guideline (see Summary of Recommended Vaccines for Adults With HIV).

To reduce community transmission and protect those with HIV, this Committee recommends rapid and universal vaccination against COVID-19 for individuals with HIV, regardless of prior history of COVID-19 infection. The Committee also recommends a third primary dose for people who are immunocompromised as defined by the Centers for Disease Control and Prevention (CDC), which includes people with untreated and advanced HIV, and a single booster dose for all individuals with HIV.

Although safety and immunogenicity data on the available vaccines against SARS-CoV-2 are still evolving, many people with HIV have multiple risk factors for severe COVID-19 infection. For more information, see:

Table 7: COVID-19/SARS-CoV-2 Vaccine (January 2022)
As determined by CDC guidelines; approved for use under FDA Emergency Use Authorizations [a,b]
Vaccine Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) Moderna COVID-19 Vaccine Johnson & Johnson (Janssen) COVID-19 Vaccine
Type of vaccine mRNA mRNA Viral vector
Authorized use ≥5 years old ≥18 years old ≥18 years old
Primary series administration
  • 2 doses
  • Administer 3 weeks apart
  • Dose for children <12 years old is lower than dose for children ≥12 years old
  • 2 doses
  • Administer 4 weeks apart
  • 1 dose
Supplemental vaccine administration: Recommended for immunocompromised patients as defined by the CDC; includes those with untreated or advanced HIV (viral load ≥200 copies/mL or CD4 count ≤200 cells/mm3) at any time during the initial vaccination period, even if no longer immunocompromised at time of supplemental dose
  • For patients ≥5 years old
  • Administer at least 28 days after dose 2 of initial series
  • Dose is the same as initial dose
  • For patients ≥18 years old
  • Administer at least 28 days after dose 2 of initial series
  • Dose is the same as initial dose
  • No additional vaccine administration
Booster vaccine administration (revaccination); see Figure below
  • For patients ≥18 years old: Pfizer-BioNTech, Moderna, or J&J (Janssen) vaccines may be used for booster
  • For patients between 12 and 17 years old who completed initial Pfizer-BioNTech vaccine series: Pfizer-BioNTech vaccine may be used for booster
  • Administer ≥5 months after dose 2 of initial series
  • Dose is the same as initial dose
  • For patients ≥18 years old: Moderna, Pfizer-BioNTech, or J&J (Janssen) vaccines may be used for booster
  • Administer ≥5 months after dose 2 of initial series
  • Moderna booster dose of 50 mcg is not the same as the primary dose of 100 mcg
  • For patients ≥18 years old: J&J (Janssen), Pfizer-BioNTech, or Moderna vaccines may be used for booster
  • Administer ≥2 months after primary vaccination
  • Dose is the same as initial dose

Abbreviation: CDC, Centers for Disease Control and Prevention.

Notes:

  1. See also: CDC > Considerations for COVID-19 vaccination in moderately or severely immunocompromised people.
  2. Covered by the Countermeasures Injury Compensation Program.

Discussion: COVID-19 morbidity and mortality are increased among individuals of older age and who have comorbidities that put them at high risk of severe disease [Bhaskaran, et al. 2021; Costenaro, et al. 2021; Mirzaei, et al. 2021; Tesoriero, et al. 2021; Cooper TJ, et al. 2020; Nandy, et al. 2020; Patel, et al. 2021; Ssentongo, et al. 2020]. Though initial studies of HIV and COVID-19–related mortality found conflicting results, a World Health Organization report based on results from 37 countries found a 30% increased risk of severe illness at hospital admission and high rates of in-hospital mortality (23.1%) for people with HIV [WHO 2021]. Because there is an increased risk of COVID-19 infection, whether due to overlapping comorbidities or disease-specific factors, people with HIV are a high-priority group for vaccination [Mellor, et al. 2021; Ssentongo, et al. 2021; Byrd, et al. 2020; Patel, et al. 2021].

The data are not clear regarding whether mixing vaccines confers greater protection than using the same brand and vaccine type for all doses. However, vaccinations should not be delayed in pursuit of a particular vaccine.

For purposes of exposure, contact tracing, and quarantine, and regardless of HIV status, people are considered fully vaccinated after completion of a primary series, but breakthrough infections are possible. People with HIV who are immunocompromised, either from advanced HIV or another cause, such as hematologic malignancy, should receive a third (supplemental) dose of the primary vaccine if they originally received the Pfizer-BioNTech or Moderna vaccine series. This supplemental dose is recommended under the FDA EUA for immunocompromised patients, including those with untreated or advanced HIV (viral load ≥200 copies/mL or CD4 count ≤200 cells/mm3) [CDC 2022]. If patients met those criteria at any point during their primary vaccination series, they should be offered a supplemental dose, even if they are no longer immunocompromised at the time of supplemental dose administration.

As of early 2022, booster vaccine administration (see Figure) is also recommended for all people, including those with treated and untreated/advanced HIV [CDC 2022; FDA 2022a].

Figure: COVID-19 Vaccine Booster Eligibility and Booster Vaccine Choice [a]
For more information, visit www.fda.gov/covid19vaccines
Primary series completed → Pfizer-BioNTech Moderna J&J (Janssen)
Booster-eligible if → It’s been ≥ 5 months since primary series completion and the patient is ≥12 years old It’s been ≥5 months since primary series completion and the patient is ≥18 years old It’s been ≥2 months since primary vaccine completion and the patient is ≥18 years old
If booster-eligible, administer →

Pfizer-BioNTech [b]
Moderna
J&J (Janssen)

Moderna
Pfizer-BioNTech [b]
J&J (Janssen)

J&J (Janssen)
Pfizer-BioNTech [b]
Moderna

Notes:

  1. Adapted from [FDA 2022b].
  2. Pfizer-BioNTech vaccine can only be used as a booster in individuals 12 to 17 years old.

The COVID-19 vaccine has been shown to be safe and highly effective at reducing severe illness, hospitalization, and mortality. Common mild adverse effects include injection site pain, headache, fatigue, myalgias, fever, and nausea. Rarely, more serious allergic reactions can occur. Reports of myocarditis have also been reported at higher rates, mostly among young men, mostly after the second dose of an mRNA vaccine, and mostly mild with spontaneous resolution. A rare blood clotting disorder has also been seen with the J&J (Janssen) vaccine in women <50 years old, as well as rare cases of Guillain-Barre Syndrome [Rosenblum, et al. 2022; Xu, et al. 2021].

To date, the clinical trials for all 3 vaccines approved under FDA EUA included approximately 900 participants with HIV, a number too small to determine efficacy specifically in this population [Baden, et al. 2021; Sadoff, et al. 2021; Polack, et al. 2020]. Nonetheless, there has also been no evidence of decreased vaccine efficacy and no reports of increased vaccine adverse effects in people with HIV. A small study showed that the Pfizer-BioNTech vaccine elicited a strong antibody response in people with HIV [Woldemeskel, et al. 2021].

KEY POINTS
  • Medical mistrust may prevent people in high vaccine priority groups from seeking or agreeing to vaccination [Bogart, et al. 2021]; heightened awareness and open discussion of medical mistrust are essential to encouraging vaccination of people with HIV.
  • The effects of systemic racism and associated health inequities made apparent by the U.S. COVID-19 pandemic may create barriers to vaccine access among some people with HIV. Clinicians who provide medical care for people with HIV are strongly encouraged to discuss and advocate for vaccination with all of their patients.
References

Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med 2021;384(5):403-416. [PMID: 33378609

Bhaskaran K, Bacon S, Evans SJ, et al. Factors associated with deaths due to COVID-19 versus other causes: population-based cohort analysis of UK primary care data and linked national death registrations within the OpenSAFELY platform. Lancet Reg Health Eur 2021;6:100109. [PMID: 33997835

Bogart LM, Ojikutu BO, Tyagi K, et al. COVID-19 related medical mistrust, health impacts, and potential vaccine hesitancy among Black Americans living with HIV. J Acquir Immune Defic Syndr 2021;86(2):200-207. [PMID: 33196555

Byrd KM, Beckwith CG, Garland JM, et al. SARS-CoV-2 and HIV coinfection: clinical experience from Rhode Island, United States. J Int AIDS Soc 2020;23(7):e25573. [PMID: 32657527

CDC. COVID-19 vaccines for moderately or severely immunocompromised people. 2022 Jan 4. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html [accessed 2022 Jan 6]

Cooper TJ, Woodward BL, Alom S, et al. Coronavirus disease 2019 (COVID-19) outcomes in HIV/AIDS patients: a systematic review. HIV Med 2020;21(9):567-577. [PMID: 32671970

Costenaro P, Minotti C, Barbieri E, et al. SARS-CoV-2 infection in people living with HIV: a systematic review. Rev Med Virol 2021;31(1):1-12. [PMID: 32875716

Crum-Cianflone NF, Wallace MR. Vaccination in HIV-infected adults. AIDS Patient Care STDS 2014;28(8):397-410. [PMID: 25029589

FDA. Coronavirus (COVID-19) update: FDA shortens interval for booster dose of moderna COVID-19 vaccine to five months. 2022a Jan 7. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-shortens-interval-booster-dose-moderna-covid-19-vaccine-five-months [accessed 2022 Jan 7]

FDA. Do I qualify for a COVID-19 vaccine booster and which one? 2022b Jan 7. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/do-i-qualify-covid-19-vaccine-booster-and-which-one [accessed 2022 Jan 11]

Mellor MM, Bast AC, Jones NR, et al. Risk of adverse coronavirus disease 2019 outcomes for people living with HIV. AIDS 2021;35(4):F1-f10. [PMID: 33587448

Mirzaei H, McFarland W, Karamouzian M, et al. COVID-19 among people living with HIV: A systematic review. AIDS Behav 2021;25(1):85-92. [PMID: 32734438

Nandy K, Salunke A, Pathak SK, et al. Coronavirus disease (COVID-19): A systematic review and meta-analysis to evaluate the impact of various comorbidities on serious events. Diabetes Metab Syndr 2020;14(5):1017-1025. [PMID: 32634716

Patel VV, Felsen UR, Fisher M, et al. Clinical outcomes and inflammatory markers by HIV serostatus and viral suppression in a large cohort of patients hospitalized with COVID-19. J Acquir Immune Defic Syndr 2021;86(2):224-230. [PMID: 33433966

Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020;383(27):2603-2615. [PMID: 33301246

Rosenblum HG, Gee J, Liu R, et al. Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Lancet Infect Dis 2022;22(6):802-812. [PMID: 35271805

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479

Sadoff J, Gray G, Vandebosch A, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. N Engl J Med 2021;384(23):2187-2201. [PMID: 33882225

Ssentongo P, Heilbrunn ES, Ssentongo AE, et al. Epidemiology and outcomes of COVID-19 in HIV-infected individuals: a systematic review and meta-analysis. Sci Rep 2021;11(1):6283. [PMID: 33737527]

Ssentongo P, Ssentongo AE, Heilbrunn ES, et al. Association of cardiovascular disease and 10 other pre-existing comorbidities with COVID-19 mortality: A systematic review and meta-analysis. PLoS One 2020;15(8):e0238215. [PMID: 32845926

Tesoriero JM, Swain CE, Pierce JL, et al. COVID-19 outcomes among persons living with or without diagnosed HIV infection in New York State. JAMA Netw Open 2021;4(2):e2037069. [PMID: 33533933]

WHO. Clinical features and prognostic factors of COVID-19 in people living with HIV hospitalized with suspected or confirmed SARS-CoV-2 infection. 2021 Jul 15. https://apps.who.int/iris/bitstream/handle/10665/342697/WHO-2019-nCoV-Clinical-HIV-2021.1-eng.pdf [accessed 2021 Dec 10]

Woldemeskel BA, Karaba AH, Garliss CC, et al. The BNT162b2 mRNA vaccine elicits robust humoral and cellular immune responses in people living with HIV. Clin Infect Dis 2021. [PMID: 34293114

Xu S, Huang R, Sy LS, et al. COVID-19 vaccination and non-COVID-19 mortality risk – seven integrated health care organizations, United States, December 14, 2020-July 31, 2021. MMWR Morb Mortal Wkly Rep 2021;70(43):1520-1524. [PMID: 34710075

Haemophilus Influenzae Type B Conjugate (Hib)

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 8: Hib Vaccine
Trade Names Hiberix; ActHIB
Indications  Patients at risk of Hib infection (see CDC: Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States 2018)
Administration  Administer according to the CDC Immunization Schedule for all adults at risk
Revaccination  None
Comments  Not routinely recommended for people with HIV in the absence of other risk factors (see the CDC Immunization Schedule)

Discussion: Hib vaccination is not routinely recommended for patients with HIV in the absence of other risk factors, such as anatomic or functional asplenia, sickle cell disease, or hematopoietic stem cell transplant, because there is a low risk of H. influenzae type b infection in adults with HIV [Briere, et al. 2014; Rubin, et al. 2014; CDC 2019]. Data on the safety and efficacy of the Hib vaccine among adults with HIV indicate a strong immune response, similar to that in adults without HIV, except among those with severe immunosuppression [Steinhoff, et al. 1991; Kroon, et al. 1997; Dockrell, et al. 1999; MacLennan, et al. 2016].

References

Briere EC, Rubin L, Moro PL, et al. Prevention and control of haemophilus influenzae type b disease: recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep 2014;63(Rr-01):1-14. [PMID: 24572654]

CDC. Immunization schedules. 2019 https://www.cdc.gov/vaccines/schedules/hcp/adult.html [accessed 2019 Dec 2]

Dockrell DH, Poland GA, Steckelberg JM, et al. Immunogenicity of three Haemophilus influenzae type b protein conjugate vaccines in HIV seropositive adults and analysis of predictors of vaccine response. Vaccine 1999;17(22):2779-2785. [PMID: 10438047]

Kroon FP, van Dissel JT, Rijkers GT, et al. Antibody response to Haemophilus influenzae type b vaccine in relation to the number of CD4+ T lymphocytes in adults infected with human immunodeficiency virus. Clin Infect Dis 1997;25(3):600-606. [PMID: 9314445]

MacLennan CA, Richter A, Hodson J, et al. Brief Report: Immunization of HIV-Infected Adults in the UK With Haemophilus influenzae b/Meningococcal C Glycoconjugate and Pneumococcal Polysaccharide Vaccines. J Acquir Immune Defic Syndr 2016;73(3):287-293. [PMID: 27163175]

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Steinhoff MC, Auerbach BS, Nelson KE, et al. Antibody responses to Haemophilus influenzae type B vaccines in men with human immunodeficiency virus infection. N Engl J Med 1991;325(26):1837-1842. [PMID: 1683682]

Hepatitis A Virus (HAV)

Medical Care Criteria Committee; December 2019, reviewed and updated March 2021

Table 9: HAV Vaccine
Trade Names
  • HAV: Havrix; Vaqta
  • HAV inactivated + hepatitis B virus (HBV): Twinrix
Indications
  • Patients aged ≥1 year with HIV [CDC 2019a]
Administration
  • Administer according to the CDC Immunization Schedule
  • Obtain HAV IgG at least 1 month after final dose of vaccination series to identify nonresponders
  • If immune reconstitution appears likely, then consider deferring until patient’s CD4 count >200 cells/mm3 [AIDSinfo 2019]
Revaccination Nonresponders to primary HAV vaccination series should be revaccinated [Aberg, et al. 2014] and counseled to avoid exposure
Comments

Discussion: The HAV vaccine is recommended for all adults with HIV who do not have immunity to HAV [CDC 2019a].

The reported rate of HAV antibody seroconversion after vaccination ranges from 49% to 96% [Fiore, et al. 2006; Crum-Cianflone and Wallace 2014; Mena, et al. 2015]. A long-term follow-up study reported that more than 85% of individuals who seroconverted after vaccination had a sustained antibody response for 5 to 10 years [Crum-Cianflone, et al. 2011; Cheng, et al. 2017]. Although immunocompetent individuals with HIV respond to the HAV vaccine nearly as well as individuals without HIV, individuals with lower CD4 cell counts are less likely to acquire protective levels of antibody [Fiore, et al. 2006; Crum-Cianflone and Wallace 2014; Mena, et al. 2015].

If a patient’s CD4 count is <200 cells/mm3 or the patient has symptomatic HIV, it is preferable to defer vaccination until several months after initiation of antiretroviral therapy to maximize the antibody response to the vaccine [AIDSinfo 2019]. HAV vaccination should not be deferred in patients who are unlikely to achieve an increased CD4 cell count (see NYSDOH AI guideline Prevention and Management of Hepatitis A Virus Infection in Adults With HIV).

Care providers should perform HAV IgG at least 1 month after final dose of vaccination series to identify nonresponders. Nonresponders to HAV vaccination should be revaccinated [Aberg, et al. 2014] and counseled to avoid exposure to HAV because they remain susceptible to infection, although a small study reported that 31% of primary nonresponders (n = 16) subsequently seroconverted after completing the 2-dose vaccination series [Cheng, et al. 2017]. If patients are susceptible to both HAV and HBV, the combined HAV/HBV vaccine (3 doses at 0, 1, and 6 months) can be used regardless of the patient’s immune status [Aberg, et al. 2014].

References

Aberg JA, Gallant JE, Ghanem KG, et al. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America. Clin Infect Dis 2014;58(1):e1-34. [PMID: 24235263]

AIDSinfo. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2019 https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/whats-new-guidelines [accessed 2019 Nov 26]

CDC. ACIP recommendations. 2019a https://www.cdc.gov/vaccines/acip/recommendations.html [accessed 2019 Dec 6]

Cheng A, Chang SY, Sun HY, et al. Long-term Durability of Responses to 2 or 3 Doses of Hepatitis A Vaccination in Human Immunodeficiency Virus-Positive Adults on Antiretroviral Therapy. J Infect Dis 2017;215(4):606-613. [PMID: 28011921]

Crum-Cianflone NF, Wallace MR. Vaccination in HIV-infected adults. AIDS Patient Care STDS 2014;28(8):397-410. [PMID: 25029589]

Crum-Cianflone NF, Wilkins K, Lee AW, et al. Long-term durability of immune responses after hepatitis A vaccination among HIV-infected adults. J Infect Dis 2011;203(12):1815-1823. [PMID: 21606540]

Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2006;55(Rr-7):1-23. [PMID: 16708058]

Mena G, Garcia-Basteiro AL, Bayas JM. Hepatitis B and A vaccination in HIV-infected adults: A review. Hum Vaccin Immunother 2015;11(11):2582-2598. [PMID: 26208678]

Hepatitis B Virus (HBV)

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 10: HBV Vaccine
Trade names
  • HBV 2-dose series: HEPLISAV-B (see note in comments)
  • HBV 3-dose series: Engerix-B; Recombivax HB
  • Hepatitis A virus (HAV) inactivated + HBV: Twinrix
Indications Patients who are negative for hepatitis B surface antibody (anti-HBs) and do not have chronic HBV infection (see CDC: Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States 2018 and the New York State Department of Health AIDS Institute (NYSDOH AI) guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV > Figure 2).
Administration
  • Administer according to the CDC Immunization Schedule for all adults [Schillie, et al. 2018]
  • Alternative administration strategies, such as a 3- or 4-injection double-dose vaccination series or an accelerated schedule of 0, 1, and 3 weeks, may be considered [AIDSinfo 2019]
  • Test for anti-HBs 1 to 2 months after administration of the last dose of the vaccination series [Rubin, et al. 2014]
Revaccination Nonresponders to the primary HBV vaccination series (anti-HBs <10 IU/L) should receive a double-dose revaccination series; a 4-dose schedule should be considered 
Comments
  • In patients at risk for HBV infection, initial vaccination should not be deferred if CD4 count is <200 cells/mm3 [AIDSinfo 2019]
  • If an accelerated schedule is used, a fourth dose booster should be administered at least 6 months after initiation of the series; the accelerated schedule is not recommended for patients with CD4 counts ­<500 cells/mm3
  • The HAV/HBV combined vaccine is not recommended for the double-dose or 4-injection HBV vaccination strategy
  • HEPLISAV-B, a 2-dose (1 month apart) recombinant HBV surface antigen vaccine with a novel adjuvant is now available [Dynavax 2017]. There are no data available on use among people with HIV. There were no autoimmune adverse events among people with HIV exposed to the adjuvant [FDA 2017]
  • See the NYSDOH AI guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV
  • Covered by the Vaccine Injury Compensation Program

Discussion: The HBV vaccine is recommended for all adults with HIV who do not have immunity to HBV and who do not have chronic HBV infection [CDC 2019]. The antibody response to the HBV vaccine is reduced in persons with HIV compared with those who do not have HIV; the reported immune response to the standard dose (20 µg) ranges from 34% to 89% [Mast, et al. 2006; Mena, et al. 2015], with diminishing response with lower CD4 cell counts [Overton, et al. 2005; Kim, et al. 2008; Pettit, et al. 2010; Pollack, et al. 2016]. Undetectable or very low viral load is associated with increased response to HBV vaccination [Overton, et al. 2005; Kim, et al. 2008; Mena, et al. 2012]. Initial vaccination should not be deferred in patients with low CD4 cell counts; some patients with HIV and CD4 counts <200 cells/mm3 may have an immune response [Whitaker, et al. 2012; AIDSinfo 2019].

Improved immune response has been reported using a 4-injection double-dose (40 µg) regimen [Launay, et al. 2011; Chaiklang, et al. 2013]. Studies of a 3-injection double-dose regimen reported increased seroconversion rates compared to standard dose only among adults with HIV with CD4 counts >350 cells/mm3 and low or undetectable HIV viral load [Fonseca, et al. 2005; Potsch, et al. 2012]. Accelerated schedules (0, 1, and 3 weeks) may increase adherence to the full vaccination series but are not recommended for patients with CD4 counts ­<500 cells/mm3 due to the increased likelihood of nonresponse [de Vries-Sluijs, et al. 2011]. Patients with HIV should be tested for anti-HBs 1 to 2 months after completing the vaccination series [Aberg, et al. 2014; AIDSinfo 2019]. Other strategies to improve immune response have demonstrated some success, including intradermal administration [Launay, et al. 2011] and addition of adjuvants [Sasaki, et al. 2003; Cooper, et al. 2005; Overton, et al. 2010], but the evidence is not sufficient to make a recommendation.

Nonresponders to primary vaccination should be revaccinated using a double-dose regimen with consideration of a 4-dose schedule. Several studies have reported increased response rates from double-dose revaccination among nonresponders [Cardell, et al. 2008; de Vries-Sluijs, et al. 2008; Psevdos, et al. 2010], although the only randomized controlled trial comparing a 3-injection standard dose (20 µg) to a 3-injection, double-dose (40 µg) regimen for revaccination found no difference in response rates. However, the double-dose regimen resulted in a greater and more durable immune response [Rey, et al. 2015]. HBV revaccination can be deferred among nonresponders who are initiating antiretroviral therapy until CD4 counts increase to ≥200 cells/mm3 [AIDSinfo 2019]. Revaccination should not be delayed in patients who are unlikely to achieve an increased CD4 cell count. For more detailed information, see NYSDOH AI guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV.

Three HBV vaccination formulations are available in the United States. The efficacy of these vaccines has been reported to be equivalent when used in patients who do not have HIV; however, the 3 formulations have not yet been established to be equally effective in patients with HIV. For persons who are susceptible to both HAV and HBV, the combined HAV/HBV vaccine can be used regardless of immune status, with 3 doses, administered at 0, 1, and 6 months. Because no data are available regarding double-dose or 4-injection HBV vaccination with the combined HAV/HBV vaccine in the presence of HIV, the combined vaccine is not recommended for the double-dose or 4-injection HBV vaccination strategy. A 2-dose (1 month apart) recombinant hepatitis B surface antigen vaccine with a novel adjuvant is available. There are no data available on use in people with HIV, but seroprotective rates were superior to comparator 3-dose series among older adults and adults with diabetes [Schillie, et al. 2018]. No autoimmune adverse events were reported among people with HIV exposed to the adjuvant [FDA 2017]. The 2-dose option may facilitate completion rates for the vaccination series. For more information, see NYSDOH AI guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV.

References

Aberg JA, Gallant JE, Ghanem KG, et al. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America. Clin Infect Dis 2014;58(1):e1-34. [PMID: 24235263]

AIDSinfo. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2019 https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/whats-new-guidelines [accessed 2019 Nov 26]

Cardell K, Akerlind B, Sallberg M, et al. Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine. J Infect Dis 2008;198(3):299-304. [PMID: 18544037]

CDC. Immunization schedules. 2019 https://www.cdc.gov/vaccines/schedules/hcp/adult.html [accessed 2019 Dec 2]

Chaiklang K, Wipasa J, Chaiwarith R, et al. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One 2013;8(11):e80409. [PMID: 24265819]

Cooper CL, Davis HL, Angel JB, et al. CPG 7909 adjuvant improves hepatitis B virus vaccine seroprotection in antiretroviral-treated HIV-infected adults. AIDS 2005;19(14):1473-1479. [PMID: 16135900]

de Vries-Sluijs TE, Hansen BE, van Doornum GJ, et al. A randomized controlled study of accelerated versus standard hepatitis B vaccination in HIV-positive patients. J Infect Dis 2011;203(7):984-991. [PMID: 21266513]

de Vries-Sluijs TE, Hansen BE, van Doornum GJ, et al. A prospective open study of the efficacy of high-dose recombinant hepatitis B rechallenge vaccination in HIV-infected patients. J Infect Dis 2008;197(2):292-294. [PMID: 18177248]

Dynavax. HEPLISAV-B: Highlights of prescribing information. 2017 Nov. https://www.heplisavb.com/assets/pdfs/HEPLISAV-B-Prescribing-Information.pdf [accessed 2019 Dec 2]

FDA. Briefing document. Heplisav-B (Hepatitis B Vaccine Recombinant and 1018 ISS Adjuvant). 2017 Jul 28. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM568492.pdf
[accessed 2019 Dec 2]

Fonseca MO, Pang LW, de Paula Cavalheiro N, et al. Randomized trial of recombinant hepatitis B vaccine in HIV-infected adult patients comparing a standard dose to a double dose. Vaccine 2005;23(22):2902-2908. [PMID: 15780739]

Kim HN, Harrington RD, Van Rompaey SE, et al. Independent clinical predictors of impaired response to hepatitis B vaccination in HIV-infected persons. Int J STD AIDS 2008;19(9):600-604. [PMID: 18725550]

Launay O, van der Vliet D, Rosenberg AR, et al. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA 2011;305(14):1432-1440. [PMID: 21486976]

Mast EE, Weinbaum CM, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. MMWR Recomm Rep 2006;55(Rr-16):1-33; quiz CE31-34. [PMID: 17159833]

Mena G, Garcia-Basteiro AL, Bayas JM. Hepatitis B and A vaccination in HIV-infected adults: A review. Hum Vaccin Immunother 2015;11(11):2582-2598. [PMID: 26208678]

Mena G, Llupia A, Garcia-Basteiro AL, et al. Assessing the immunological response to hepatitis B vaccination in HIV-infected patients in clinical practice. Vaccine 2012;30(24):3703-3709. [PMID: 22446635]

Overton ET, Kang M, Peters MG, et al. Immune response to hepatitis B vaccine in HIV-infected subjects using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant: ACTG study 5220. Vaccine 2010;28(34):5597-5604. [PMID: 20600512]

Overton ET, Sungkanuparph S, Powderly WG, et al. Undetectable plasma HIV RNA load predicts success after hepatitis B vaccination in HIV-infected persons. Clin Infect Dis 2005;41(7):1045-1048. [PMID: 16142673]

Pettit NN, DePestel DD, Malani PN, et al. Factors associated with seroconversion after standard dose hepatitis B vaccination and high-dose revaccination among HIV-infected patients. HIV Clin Trials 2010;11(6):332-339. [PMID: 21239361]

Pollack TM, Trang le TT, Ngo L, et al. Response to hepatitis B vaccination among HIV-infected adults in Vietnam. J Virus Erad 2016;2(2):102-106. [PMID: 27482443]

Potsch DV, Camacho LA, Tuboi S, et al. Vaccination against hepatitis B with 4-double doses increases response rates and antibodies titers in HIV-infected adults. Vaccine 2012;30(41):5973-5977. [PMID: 22828589]

Psevdos G, Kim JH, Groce V, et al. Efficacy of double-dose hepatitis B rescue vaccination in HIV-infected patients. AIDS Patient Care STDS 2010;24(7):403-407. [PMID: 20586648]

Rey D, Piroth L, Wendling MJ, et al. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis 2015;15(11):1283-1291. [PMID: 26257021]

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Sasaki M, Foccacia R, de Messias-Reason IJ. Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection. Vaccine 2003;21(31):4545-4549. [PMID: 14575766]

Schillie S, Vellozzi C, Reingold A, et al. Prevention of hepatitis B virus infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2018;67(1):1-31. [PMID: 29939980

Whitaker JA, Rouphael NG, Edupuganti S, et al. Strategies to increase responsiveness to hepatitis B vaccination in adults with HIV-1. Lancet Infect Dis 2012;12(12):966-976. [PMID: 23174382]

Human Papillomavirus (HPV)

Medical Care Criteria Committee; December 2019, reviewed and updated March 2022

Table 11: HPV Vaccine
Trade Names Gardasil 9
Indications All patients aged 9 to 45 years who were not previously vaccinated or did not receive a complete 3-dose series (see Centers for Disease Control and Prevention [CDC] Adult Immunization Schedule: Recommendations for Ages 19 Years or Older, United States, 2022).
Administration Administer through age 45 years as a 3-dose series according to the CDC Immunization Schedule for adults with immunocompromising conditions.
Revaccination None 
Comments

Discussion:  In 2006, the U.S. Food and Drug Administration (FDA) approved a 9-valent vaccine that protects against nononcogenic HPV types 6 and 11 and oncogenic HPV types 16, 18, 31, 33, 45, 52, and 58 (Gardasil 9). Because it offers broader coverage of HPV types than other vaccines, the 9-valent vaccine is the only HPV vaccine available in the United States (see CDC Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV for more information). The HPV vaccine is approved by the FDA for preventive but not therapeutic use.

Extrapolating data from the demonstrated effectiveness of the quadrivalent HPV vaccine in older individuals [Wilkin, et al. 2018], the FDA expanded the age range for approved use of the HPV vaccine in the United States from ages 9 to 26 years to ages 9 to 45 years [FDA 2020]. There is no specific mention of HIV infection in the updated FDA approval. Although 1 study demonstrated lower efficacy of the quadrivalent vaccine in individuals with HIV [Wilkin, et al. 2018], other research linked HIV viral suppression to vaccine efficacy [Money, et al. 2016].

When to vaccinate: HPV vaccination may be scheduled at the same time as standard adolescent vaccines offered at ages 9 to 12 years [CDC 2021]. If possible, the HPV vaccine series should begin at 9 years old. The 3-dose vaccine is recommended for all patients with HIV who are 9 to 45 years old. The 9-valent HPV vaccine should be administered according to the CDC standard schedule for immunocompromised adults, children, and adolescents (a 3-dose regimen over a 6-month period at 0, 2, and 6 months) and should be offered regardless of CD4 cell count.

HPV vaccination provides high levels of neutralizing antibodies for at least 5 years and is protective in individuals ≤26 years old who do not have HIV, regardless of history of sexual activity; however, the full length of its protection has not been established. In an observational study conducted in England that examined the effectiveness of a national HPV immunization program, the reduction in cervical cancer was greatest in individuals who received the vaccine at ages 12 to 13 years [Falcaro, et al. 2021]. Although data are limited, the immunogenicity of the quadrivalent HPV vaccine has been demonstrated in individuals with HIV [Wilkin, et al. 2018; Kojic, et al. 2014].

Vaccination is not expected to change the course of established HPV infections but may prevent infection from other strains that are part of a polyvalent vaccine.

HPV testing and vaccination: HPV testing is not recommended before vaccine administration. It is unlikely that an individual will have been infected with all the HPV types covered by the 9-valent vaccine; therefore, it is expected that the 9-valent HPV vaccine will be effective against any of the 9 HPV types or any HPV types to which the individual has not been exposed. There also may be beneficial prevention due to cross-reactivity with other HPV types not included in the 9-valent vaccine [Wheeler, et al. 2012].

Revaccination with the 9-valent HPV vaccine is not currently recommended for individuals who previously received the bivalent or quadrivalent HPV vaccine [Petrosky, et al. 2015]. Vaccination with the quadrivalent HPV vaccine has demonstrated cross-protection against other oncogenic HPV types [Kemp, et al. 2011]. There is no maximum interval between vaccine doses as long as 3 doses are given, so there is no need to repeat doses if a scheduled vaccination is missed [CDC 2021].

References

CDC. HPV vaccine schedule and dosing. 2021 Nov 1. https://www.cdc.gov/hpv/hcp/schedules-recommendations.html [accessed 2022 Mar 24]

Falcaro M, Castanon A, Ndlela B, et al. The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. Lancet 2021. [PMID: 34741816

FDA. Vaccines, blood & biologics: Gardasil 9. 2020 Aug 21. https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm426445.htm [accessed 2022 Mar 22]

Kemp TJ, Hildesheim A, Safaeian M, et al. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine 2011;29(11):2011-2014. [PMID: 21241731]

Kojic EM, Kang M, Cespedes MS, et al. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis 2014;59(1):127-135. [PMID: 24723284

Money DM, Moses E, Blitz S, et al. HIV viral suppression results in higher antibody responses in HIV-positive women vaccinated with the quadrivalent human papillomavirus vaccine. Vaccine 2016;34(40):4799-4806. [PMID: 27544584

Petrosky E, Bocchini JA, Jr., Hariri S, et al. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep 2015;64(11):300-304. [PMID: 25811679

Wheeler CM, Castellsague X, Garland SM, et al. Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012;13(1):100-110. [PMID: 22075170

Wilkin TJ, Chen H, Cespedes MS, et al. A randomized, placebo-controlled trial of the quadrivalent human papillomavirus vaccine in human immunodeficiency virus-infected adults aged 27 years or older: AIDS Clinical Trials Group Protocol A5298. Clin Infect Dis 2018;67(9):1339-1346. [PMID: 29659751

Influenza

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 12: Influenza Vaccine
Trade Names See Centers for Disease Control and Prevention (CDC) flu vaccines table
Indications For all patients, as determined by CDC guidelines for all adults
Administration Administer annually during flu season (October through May) according to CDC guidelines for all adults
Revaccination None
Comments Covered by the Vaccine Injury Compensation Program

Discussion: People with HIV are at greater risk of severe morbidity from an influenza infection [Kunisaki and Janoff 2009; Grohskopf, et al. 2019] than people who do not have HIV and should be vaccinated annually during flu season (October through May) according to standard (CDC) guidelines for all adults [Aberg, et al. 2014; Grohskopf, et al. 2019]. Inactivated influenza vaccine offers protective immunity in adults with HIV [Beck, et al. 2012; Remschmidt, et al. 2014; Grohskopf, et al. 2019]. Live, attenuated influenza vaccine should not be used for individuals with HIV. Antibody titers lower than those observed in the general population have been reported among adults with HIV, especially among those with advanced HIV disease who are older than 35 years, have low CD4 cell counts, and have detectable viremia [Kroon, et al. 2000; Yamanaka, et al. 2005; Evison, et al. 2009; Crum-Cianflone, et al. 2011; Garg, et al. 2016]. Studies comparing intradermal and intramuscular vaccines report no difference in immunogenicity, but intradermal vaccination is associated with increased likelihood of redness, swelling, and tenderness at the injection site [Garg, et al. 2016; Seo, et al. 2016].

The CDC does not recommend a second vaccination in individuals with HIV [Grohskopf, et al. 2019], although one study reported that a second dose of an adjuvanted vaccine significantly increased the rate of seroprotective responses [Bickel, et al. 2011]. There is some evidence that influenza seroprotection is higher for people aged 18 years or older who are given a double-dose vaccine than for those given the standard dose vaccine, but the clinical significance of this remains unknown [Cooper, et al. 2011; McKittrick, et al. 2013]. Another study among children and young adults (aged 3 to 21 years) found no increased immunity among participants with HIV who received the double-dose vaccine [Hakim, et al. 2016]. The high-dose vaccine is not licensed for people older than 65 years.

Results of 2 studies suggest a possible benefit to delaying influenza vaccination to after mid-November; patients vaccinated later in the flu season had lower rates of laboratory-confirmed influenza and influenza-like illnesses than those vaccinated earlier in the season [Werker, et al. 2014; Glinka, et al. 2016]. Monitoring regional influenza activity will help ensure appropriate timing of influenza vaccination. There is no recommendation for post-vaccination serologic testing to determine immune response [Grohskopf, et al. 2019].

References

Aberg JA, Gallant JE, Ghanem KG, et al. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America. Clin Infect Dis 2014;58(1):e1-34. [PMID: 24235263]

Beck CR, McKenzie BC, Hashim AB, et al. Influenza vaccination for immunocompromised patients: systematic review and meta-analysis by etiology. J Infect Dis 2012;206(8):1250-1259. [PMID: 22904335]

Bickel M, von Hentig N, Wieters I, et al. Immune response after two doses of the novel split virion, adjuvanted pandemic H1N1 influenza A vaccine in HIV-1-infected patients. Clin Infect Dis 2011;52(1):122-127. [PMID: 21148530]

Cooper C, Thorne A, Klein M, et al. Immunogenicity is not improved by increased antigen dose or booster dosing of seasonal influenza vaccine in a randomized trial of HIV infected adults. PLoS One 2011;6(3):e17758. [PMID: 21512577]

Crum-Cianflone NF, Eberly LE, Duplessis C, et al. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults. Clin Infect Dis 2011;52(1):138-146. [PMID: 21148532]

Evison J, Farese S, Seitz M, et al. Randomized, double-blind comparative trial of subunit and virosomal influenza vaccines for immunocompromised patients. Clin Infect Dis 2009;48(10):1402-1412. [PMID: 19361304]

Garg S, Thongcharoen P, Praphasiri P, et al. Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand. Clin Infect Dis 2016;62(3):383-391. [PMID: 26486702]

Glinka ER, Smith DM, Johns ST. Timing Matters – Influenza Vaccination to HIV-Infected Patients. HIV Med 2016;17(8):601-604. [PMID: 26810556]

Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and control of seasonal influenza with caccines: Recommendations of the Advisory Committee on Immunization Practices – United States, 2019-20 influenza season. MMWR Recomm Rep 2019;68(3):1-21. [PMID: 31441906]

Hakim H, Allison KJ, Van de Velde LA, et al. Immunogenicity and safety of high-dose trivalent inactivated influenza vaccine compared to standard-dose vaccine in children and young adults with cancer or HIV infection. Vaccine 2016;34(27):3141-3148. [PMID: 27129426]

Kroon FP, van Dissel JT, de Jong JC, et al. Antibody response after influenza vaccination in HIV-infected individuals: a consecutive 3-year study. Vaccine 2000;18(26):3040-3049. [PMID: 10825608]

Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis 2009;9(8):493-504. [PMID: 19628174]

McKittrick N, Frank I, Jacobson JM, et al. Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial. Ann Intern Med 2013;158(1):19-26. [PMID: 23277897]

Remschmidt C, Wichmann O, Harder T. Influenza vaccination in HIV-infected individuals: systematic review and assessment of quality of evidence related to vaccine efficacy, effectiveness and safety. Vaccine 2014;32(43):5585-5592. [PMID: 25131742]

Seo YB, Lee J, Song JY, et al. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine. Hum Vaccin Immunother 2016;12(2):478-484. [PMID: 26431466]

Werker GR, Sharif B, Sun H, et al. Optimal timing of influenza vaccination in patients with human immunodeficiency virus: a Markov cohort model based on serial study participant hemoagglutination inhibition titers. Vaccine 2014;32(6):677-684. [PMID: 24355089]

Yamanaka H, Teruya K, Tanaka M, et al. Efficacy and immunologic responses to influenza vaccine in HIV-1-infected patients. J Acquir Immune Defic Syndr 2005;39(2):167-173. [PMID: 15905732]

Measles, Mumps, Rubella (MMR)

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 13: MMR Vaccine
Trade Names
  • M-M-R II
  • MMR + varicella: ProQuad 
Indications For patients with CD4 counts ≥200 cells/mm3 who do not have evidence of MMR immunity, as determined by the CDC’s Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States 2018 
Administration Two doses at least 28 days apart (see the CDC Immunization Schedule)
Revaccination Recommended only in the setting of an outbreak (see the CDC Immunization Schedule)
Comments
  • Contraindicated for patients with CD4 counts <200 cells/mm3 (see the CDC Immunization Schedule)
  • MMR + varicella (MMRV) should not be substituted for MMR [McLean, et al. 2013; Rubin, et al. 2014]
  • Those who previously received 2 doses of a mumps-containing vaccine and are at increased risk for mumps in the setting of an outbreak should receive a third dose to improve protection against mumps disease and related complications [Marin, et al. 2018]
  • Covered by the Vaccine Injury Compensation Program

Discussion: Immunocompromised persons are at increased risk of serious and life-threatening complications if infected with measles [McLean, et al. 2013]. Patients with HIV who have CD4 counts ≥200 cells/mm3 and who do not have evidence of immunity to MMR should be vaccinated with 2 doses of MMR vaccine at least 28 days apart. Documentation of previous age-appropriate vaccination or laboratory confirmation of prior disease is acceptable evidence of immunity. Serologic screening is required if other acceptable evidence of immunity is not available and to determine rubella immunity among individuals of childbearing potential. In the absence of other evidence of immunity, persons with perinatally acquired HIV who received childhood vaccination with MMR before establishment of effective ART should be revaccinated (2 doses) after effective antiretroviral therapy (ART) is established [McLean, et al. 2013]. There is no recommendation for post-vaccination serologic testing to determine immune response [McLean, et al. 2013].

Two studies that examined the antibody response after MMR vaccination in adults with HIV taking ART reported high levels of protective antibodies post-vaccination, although the levels were lower than in adults without HIV. A study conducted in Mexico among adults with HIV who were seronegative for measles reported no significant difference in initial antibody response to measles vaccination between adults with and without HIV (81% vs 85%). However, at 1 year, the observed decline in antibody response was faster in adults with HIV than in those without HIV [Belaunzaran-Zamudio, et al. 2009]. A study in Thailand reported protective antibodies to measles (74.1%), mumps (65.7%), and rubella (93.3%) among adults with HIV 8 to 12 weeks after vaccination with MMR. Compared with adults without HIV, the seroconversion rates were lower but reached statistical significance only for mumps [Chaiwarith, et al. 2016].

No data are available on revaccination in adults with HIV. Revaccination has improved measles antibody response in children with HIV on ART who had an inadequate initial response to vaccination [Aurpibul, et al. 2007; Abzug, et al. 2012]. If persons previously vaccinated with 2 doses of a mumps-containing vaccine are identified as at increased risk for mumps by public health authorities because of an outbreak, these at-risk individuals should receive a third dose of a mumps-containing vaccine to improve protection against mumps disease and related complications [Marin, et al. 2018].

MMR vaccination contains live virus and is contraindicated for patients with CD4 counts <200 cells/mm3 due to reports of adverse events, such as measles pneumonitis, in severely compromised patients [CDC 1996; Angel, et al. 1998]. Serious adverse effects have not been reported in adults who were not severely immunocompromised [Belaunzaran-Zamudio, et al. 2009; McLean, et al. 2013; Chaiwarith, et al. 2016]. MMRV has not been adequately studied in individuals with HIV and is not recommended as a substitute for MMR in this population [McLean, et al. 2013; Rubin, et al. 2014].

References

Abzug MJ, Qin M, Levin MJ, et al. Immunogenicity, immunologic memory, and safety following measles revaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis 2012;206(4):512-522. [PMID: 22693229]

Angel JB, Walpita P, Lerch RA, et al. Vaccine-associated measles pneumonitis in an adult with AIDS. Ann Intern Med 1998;129(2):104-106. [PMID: 9669968]

Aurpibul L, Puthanakit T, Sirisanthana T, et al. Response to measles, mumps, and rubella revaccination in HIV-infected children with immune recovery after highly active antiretroviral therapy. Clin Infect Dis 2007;45(5):637-642. [PMID: 17683001]

Belaunzaran-Zamudio PF, Garcia-Leon ML, Wong-Chew RM, et al. Early loss of measles antibodies after MMR vaccine among HIV-infected adults receiving HAART. Vaccine 2009;27(50):7059-7064. [PMID: 19799846]

CDC. Measles pneumonitis following measles-mumps-rubella vaccination of a patient with HIV infection, 1993. MMWR Morb Mortal Wkly Rep 1996;45(28):603-606. [PMID: 8676852]

Chaiwarith R, Praparattanapan J, Nuket K, et al. Seroprevalence of antibodies to measles, mumps, and rubella, and serologic responses after vaccination among human immunodeficiency virus (HIV)-1 infected adults in Northern Thailand. BMC Infect Dis 2016;16:190. [PMID: 27138005]

Marin M, Marlow M, Moore KL, et al. Recommendation of the Advisory Committee on Immunization Practices for Use of a Third Dose of Mumps Virus-Containing Vaccine in Persons at Increased Risk for Mumps During an Outbreak. MMWR Morb Mortal Wkly Rep 2018;67(1):33-38. [PMID: 29324728]

McLean HQ, Fiebelkorn AP, Temte JL, et al. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2013;62(Rr-04):1-34. [PMID: 23760231]

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Meningococcal Serotype Non-B (MenACWY)

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 14: MenACWY Vaccine
Trade Names
  • MenACWY: Menactra
  • MCV4: Menveo
Indications
Administration
  • Administer 2 doses of MenACWY at least 8 weeks apart in those not previously vaccinated (see the CDC Immunization Schedule)
  • For those previously vaccinated with 1 dose of MenACWY, administer the second dose at the earliest opportunity at least 8 weeks after the previous dose (see the CDC Immunization Schedule)
Revaccination Administer 1 booster dose of MenACWY every 5 years (see the CDC Immunization Schedule)
Comments

Discussion: Adults with HIV are at increased risk of invasive meningococcal disease due to serogroups C, W, and Y. [MacNeil, et al. 2016; Folaranmi, et al. 2017]. A recent study in New York City reported a 10-fold increased risk of invasive meningococcal disease in patients with HIV, with the highest risk among those with CD4 counts <200 cells/mm3 [Miller, et al. 2014]. As of 2017, the CDC recommends vaccinating all previously unvaccinated adults with HIV with a 2-dose primary series of MenACWY (MenACWY-CRM or MenACWY-D) administered at least 8 weeks apart [MacNeil, et al. 2016].

Data on meningococcal vaccine efficacy among adults with HIV are not currently available [MacNeil, et al. 2016]. Among adolescents with HIV, available evidence indicates that the vaccine is immunogenic and serious adverse events are rare, but adolescents with HIV (and especially those with lower CD4 cell counts and higher viral loads) had reduced antibody levels compared with adolescents without HIV [Siberry, et al. 2010; Lujan-Zilbermann, et al. 2012]. Adding a second vaccine dose significantly improved antibody levels 28 and 72 weeks after immunization, particularly among adolescents with CD4% >15 [Lujan-Zilbermann, et al. 2012].

Booster doses every 5 years are needed to maintain immunity. Although MPSV4 is the only meningococcal vaccine licensed for persons aged 56 years or older, MenACWY is preferred among older adults because of the need for revaccination. Limited data among adults without HIV suggest a greater immune response after a booster dose of MenACWY than with MPSV4; however, no data are available for adults with HIV. There is no recommendation for post-vaccination serologic testing to determine immune response [MacNeil, et al. 2016].

References

Folaranmi TA, Kretz CB, Kamiya H, et al. Increased Risk for Meningococcal Disease among Men who have Sex with Men in the United States, 2012-2015. Clin Infect Dis 2017. [PMID: 28505234]

Lujan-Zilbermann J, Warshaw MG, Williams PL, et al. Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus. J Pediatr 2012;161(4):676-681.e672. [PMID: 22622049]

MacNeil JR, Rubin LG, Patton M, et al. Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons – Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep 2016;65(43):1189-1194. [PMID: 27811836]

Miller L, Arakaki L, Ramautar A, et al. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med 2014;160(1):30-37. [PMID: 24166695]

Siberry GK, Williams PL, Lujan-Zilbermann J, et al. Phase I/II, open-label trial of safety and immunogenicity of meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine in human immunodeficiency virus-infected adolescents. Pediatr Infect Dis J 2010;29(5):391-396. [PMID: 20431379]

Meningococcal Serotype B (MenB)

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 15: MenB Vaccine
Trade Names Bexsero; Trumenba
Indications Patients at risk of MenB infection, as determined by the CDC’s Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States 2018 
Administration Administer according to the CDC Immunization Schedule for patients at risk
Revaccination None
Comments

Discussion: MenB vaccine is not routinely recommended for adults with HIV unless they have another indication for immunization. No increased risk of serogroup B meningococcal disease among individuals with HIV has been reported [CDC 2019].

Reference

CDC. Immunization schedules. 2019 https://www.cdc.gov/vaccines/schedules/hcp/adult.html [accessed 2019 Dec 2]

Mpox Vaccine in Adults With HIV

Lead author: Mary Dyer, MD
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Joseph P. McGowan, MD, FACP, FIDSA; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date published: July 29, 2022

RECOMMENDATIONS
Mpox Vaccination in Adults With HIV
  • Clinicians should recommend vaccination against mpox for individuals ≥18 years old with HIV who are at high risk of or who have been exposed to mpox within the past 14 days and for whom vaccination may reduce the risk of infection or decrease symptoms if infection has occurred. (A2)
  • Clinicians should use only the JYNNEOS (Imvamune or Imvanex) mpox vaccine for individuals with HIV, as it is the only available vaccine that is considered safe for administration in this population. (A*)
  • Clinicians should recommend vaccination for adults with HIV, regardless of their CD4 count and degree of viral suppression. (A3)
Table: Mpox Vaccine [a]
Trade name JYNNEOS (also called Imvamune or Imvanex)
Type of vaccine Live virus that does not replicate efficiently in human cells
Administration Two subcutaneous injections 4 weeks apart
Indication Approved by FDA for prevention of smallpox or mpox in people ≥18 years old
Adverse reactions Injection site reactions such as pain, swelling, and redness. Vaccination with JYNNEOS will not cause mpox infection
Contraindications
Severe allergy to any component of the vaccine (gentamicin, ciprofloxacin, or egg protein)
Immune response Maximal development of the immune response takes 2 weeks after second dose
Pregnancy/
breastfeeding
No evidence of reproductive harm from animal data. Pregnancy and breastfeeding are not contraindications for vaccination

Note:

  1. See the U.S. Food and Drug Administration (FDA) package insert and Centers for Disease Control and Prevention Interim Guidance for Prevention and Treatment of Monkeypox in Persons with HIV Infection — United States, August 2022 for more information.

Immunization: The Centers for Disease Control and Prevention (CDC) considers people with HIV to be at risk for severe mpox disease and recommends prioritization of those at risk for receipt of the JYNNEOS mpox vaccine [CDC 2022]. Vaccination is used to prevent mpox and as post-exposure prophylaxis; it protects against disease when administered before exposure. If administered after exposure, the vaccine may prevent development or decrease the severity of mpox disease. See CDC: Interim Guidance for Prevention and Treatment of Monkeypox in Persons with HIV Infection — United States, August 2022.

Two vaccines against mpox are currently approved by the U.S. Food and Drug Administration: JYNNEOS (Imvamune or Imvanex) and ACAM2000. Only JYNNEOS is safe for people with HIV. The ACAM2000 vaccine is contraindicated in adults with HIV and their household contacts.

JYNNEOS contains live vaccinia virus, but the virus does not replicate in humans. JYNNEOS is considered safe to use in adults with HIV regardless of viral load or CD4 cell count. No data are available on the effectiveness of available mpox vaccines in this current outbreak.

The safety and immunogenicity of the JYNNEOS vaccine have been evaluated in adults with HIV; however, the immunogenicity is unknown in individuals who are not virally suppressed or who have with CD4 counts ≤200 cells/mm3. Vaccine efficacy may be lower in patients with low CD4 cell counts. However, given the risk of severe illness in immunosuppressed individuals, vaccination is recommended regardless of CD4 cell count and degree of viral suppression.

Vaccine dosing: The CDC recommends the mpox vaccine be given within 4 days of exposure to prevent disease. If given 4 to 14 after exposure, vaccination may not prevent disease but may reduce symptoms [CDC 2022]. Peak immunogenicity is achieved 2 weeks after the second JYNNEOS dose [Rao, et al. 2022].

KEY POINTS
  • JYNNEOS (Imvamune or Imvanex) is the only mpox vaccination safe for adults with HIV.
  • Care should be taken to avoid language and behavior that marginalizes and stigmatizes communities at risk.

Presentation: A high index of suspicion is required because the clinical presentation of mpox disease can vary from a few scattered papules and mild constitutional symptoms to severe illness. Symptoms of mpox may include fever, headache, muscle aches, backache, swollen lymph nodes, moderate to severe pain, exhaustion, and rash that may include painful oral, anal, or genital lesions.

Mortality: Studies of mpox in remote, medically underserved areas of Central Africa have reported mortality of 11% in unvaccinated individuals [Durski, et al. 2018]. People with advanced HIV or who are not virally suppressed may be at risk of severe disease. To date, no deaths have been reported in the United States during the current outbreak.

Transmission: Although many of those affected in the current global outbreaks are men who have sex with men, the virus can be acquired by anyone who has been in close contact with someone with mpox. The virus that causes mpox is transmitted via the following:

  • Direct skin-to-skin contact with an infectious rash, scabs, or body fluids
  • Exposure to respiratory secretions during prolonged face-to-face contact or intimate physical contact, such as kissing, cuddling, or sex
  • Touching objects or fabrics (e.g., clothing or linens) that have been in contact with the rash or body fluids of someone with mpox
  • Being scratched or bitten by an infected animal
RESOURCES
NYSDOH:
NYC Health:
CDC:
References

CDC. Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak. 2022 Oct 19. https://www.cdc.gov/poxvirus/monkeypox/considerations-for-monkeypox-vaccination.html [accessed 2022 Jul 18]

Durski KN, McCollum AM, Nakazawa Y, et al. Emergence of monkeypox – West and Central Africa, 1970-2017. MMWR Morb Mortal Wkly Rep 2018;67(10):306-310. [PMID: 29543790]

Rao AK, Petersen BW, Whitehill F, et al. Use of JYNNEOS (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the advisory committee on immunization practices – United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71(22):734-742. [PMID: 35653347

Pneumococcal

Reviewed and updated: Mary Dyer, MD, with the Medical Care Criteria Committee; October 2022

Table 16: Pneumococcal Vaccine
(see also Centers for Disease Control and Prevention Adult Immunization Schedule and PneumoRecs VaxAdvisor)
Trade Names Vaxneuvance (PCV15; 15-valent pneumococcal conjugate vaccine); Prevnar 20 (PCV20; 20-valent pneumococcal conjugate vaccine); Pneumovax 23 (PPSV23; 23-valent pneumococcal polysaccharide vaccine)
Indications All patients with HIV
Administration For patients who have not received a pneumococcal vaccine or whose vaccination status is unknown: Vaccinate with 1 dose of PCV15 or 1 dose of PCV20. If PCV15 is used, follow with 1 dose of PPSV23, with a minimum interval of 8 weeks between the doses. (See Figure 1, below.)
Revaccination See Figure 2, below, for detailed administration guidelines based on age and pneumococcal vaccination history.
Comments Pneumococcal vaccination should be not be deferred for patients with CD4 count <200 cells/mm3 and/or detectable viral load; however, the follow-up secondary administration of the PPSV23 vaccine may be deferred until the patient’s CD4 count is >200 cells/mm3 and/or viral load is undetectable. If zoster vaccine is also being administered, it should be separated from the pneumococcal vaccine by at least 4 weeks [FDA 2019].

Discussion: Individuals with HIV are at increased risk of serious disease due to Streptococcus pneumoniae, including bacteremia, meningitis, and pneumonia. Pneumococcal vaccination is recommended for all adults with HIV as soon as possible after HIV diagnosis [CDC 2022; Kobayashi, et al. 2022]. Patients who have not previously been vaccinated or whose vaccination status is unknown should receive 1 dose of the 15-valent pneumococcal conjugate vaccine (PCV15) or 1 dose of the 20-valent pneumococcal conjugate vaccine (PCV20); if PCV15 is used, it should be followed with 1 dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23), with a minimum interval of 8 weeks between the doses. There is no recommendation for post-vaccination serologic testing to determine immune response [CDC 2022; Kobayashi, et al. 2022]. See Figures 1 and 2 below, for vaccination recommendations by pneumococcal immunization history.

Pneumococcal vaccination has been shown to reduce pneumococcal bacteremia and mortality among adults with HIV [Chowers, et al. 2017; Rodriguez-Barradas, et al. 2008; Grau, et al. 2005; Hung, et al. 2004]. Both polysaccharide and conjugate pneumococcal vaccines appear to be safe and immunogenic among adults with HIV who have CD4 counts ≥200 cells/mm3 [Lombardi, et al. 2016; Bhorat, et al. 2015; Rodriguez-Barradas, et al. 2015; Ho, et al. 2013].

Patients with CD4 counts <200 cells/mm3 are at the highest risk of pneumococcal disease. Immunogenicity was demonstrated for individuals with HIV with CD4 counts <200 cells/mmwho received PCV7 [French, et al. 2010]. Patients with HIV who have not previously received any pneumococcal vaccine should receive a dose of PCV15 or PCV20, regardless of CD4 cell count. Although there is evidence of the effectiveness of PPSV23 among patients with CD4 counts <200 cells/mm3, the benefit appears to be greatest among patients with HIV RNA levels <100,000 copies/mL and among those who are on antiretroviral therapy [French, et al. 2010].

Contraindications to pneumococcal vaccination include a history of anaphylaxis caused by any vaccine component. Patients with a history of an anaphylactic reaction to any conjugate vaccines or diphtheria toxoid should not receive conjugate vaccine [CDC 2022].

Figure 1: Pneumococcal Immunization Recommendation for Unvaccinated Adults With HIV ≥19 Years Old [a]

Abbreviations: PCV15, 15-valent pneumococcal conjugate vaccine (brand name Vaxneuvance); PCV20, 20-valent pneumococcal conjugate vaccine (brand name Prevnar 20); PPSV23, 23-valent pneumococcal polysaccharide vaccine (brand name Pneumovax 23).

Note:

  1. See also Centers for Disease Control and Prevention Adult Immunization Schedule and PneumoRecs VaxAdvisor.

Download Figure 1 PDF

 

Figure 2: Pneumococcal Immunization Recommendations for Previously Vaccinated Adults With HIV [a]

Abbreviations: CDC, Centers for Disease Control and Prevention; PCV13, 13-valent pneumococcal conjugate vaccine (brand name Prevnar 13); PCV15, 15-valent pneumococcal conjugate vaccine (brand name Vaxneuvance); PCV20, 20-valent pneumococcal conjugate vaccine (brand name Prevnar 20); PPSV23, 23-valent pneumococcal polysaccharide vaccine (brand name Pneumovax 23).

Notes:

  1. See also Centers for Disease Control and Prevention Adult Immunization Schedule and PneumoRecs VaxAdvisor.
  2. Immunization is complete if the last PPSV23 dose was received at ≥65 years old.

Download Figure 2 PDF

 

References

Bhorat AE, Madhi SA, Laudat F, et al. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS 2015;29(11):1345-1354. [PMID: 25888646

CDC. Adult immunization schedule. 2022 https://www.cdc.gov/vaccines/schedules/hcp/adult.html [accessed 2022 Jul 27]

Chowers M, Regev-Yochay G, Mor O, et al. Invasive pneumococcal disease (IPD) in HIV infected patients in Israel since the introduction of pneumococcal conjugated vaccines (PCV): Analysis of a nationwide surveillance study, 2009-2014. Hum Vaccin Immunother 2017;13(1):216-219. [PMID: 27648488

FDA. Zostavax package insert. 2019 Dec 26. https://www.fda.gov/vaccines-blood-biologics/vaccines/zostavax [accessed 2022 Oct 4]

French N, Gordon SB, Mwalukomo T, et al. A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. N Engl J Med 2010;362(9):812-822. [PMID: 20200385

Grau I, Pallares R, Tubau F, et al. Epidemiologic changes in bacteremic pneumococcal disease in patients with human immunodeficiency virus in the era of highly active antiretroviral therapy. Arch Intern Med 2005;165(13):1533-1540. [PMID: 16009870

Ho YL, Brandao AP, de Cunto Brandileone MC, et al. Immunogenicity and safety of pneumococcal conjugate polysaccharide and free polysaccharide vaccines alone or combined in HIV-infected adults in Brazil. Vaccine 2013;31(37):4047-4053. [PMID: 23684823

Hung CC, Chen MY, Hsieh SM, et al. Clinical experience of the 23-valent capsular polysaccharide pneumococcal vaccination in HIV-1-infected patients receiving highly active antiretroviral therapy: a prospective observational study. Vaccine 2004;22(15-16):2006-2012. [PMID: 15121313

Kobayashi M, Farrar JL, Gierke R, et al. Use of 15-Valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among U.S. adults: updated recommendations of the Advisory Committee on Immunization Practices – United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71(4):109-117. [PMID: 35085226

Lombardi F, Belmonti S, Fabbiani M, et al. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine versus the 23-valent polysaccharide vaccine in unvaccinated HIV-infected adults: A pilot, prospective controlled study. PLoS One 2016;11(6):e0156523. [PMID: 27258647

Rodriguez-Barradas MC, Goulet J, Brown S, et al. Impact of pneumococcal vaccination on the incidence of pneumonia by HIV infection status among patients enrolled in the Veterans Aging Cohort 5-Site Study. Clin Infect Dis 2008;46(7):1093-1100. [PMID: 18444830

Rodriguez-Barradas MC, Serpa JA, Munjal I, et al. Quantitative and qualitative antibody responses to immunization with the pneumococcal polysaccharide vaccine in HIV-infected patients after initiation of antiretroviral treatment: Results from a randomized clinical trial. J Infect Dis 2015;211(11):1703-1711. [PMID: 25538270

Tetanus, Diphtheria, and Pertussis (Tdap) and Tetanus-Diphtheria (Td)

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 16: Tdap and Td Vaccines
Trade Names
  • Tdap: Adacel; Boostrix
  • Td: Tenivac; Decavac (generic 9Td)
Indications For all patients, as determined by the CDC’s Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States 2018 for all adults
Administration Administer according to the CDC Immunization Schedule for all adults
Revaccination Td is usually given as a booster dose every 10 years, but it can also be given earlier after a severe and dirty wound or burn
Comments Covered by the Vaccine Injury Compensation Program

Discussion: The recommendations for Tdap and Td vaccination of adults with HIV are the same as for all adults [CDC 2019]. The safety and efficacy of vaccination with Tdap has not been studied in this population [Rubin, et al. 2014].

References

CDC. Immunization schedules. 2019 https://www.cdc.gov/vaccines/schedules/hcp/adult.html [accessed 2019 Dec 2]

Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Varicella

Medical Care Criteria Committee; December 2019, reviewed and updated February 2021

Table 18: Varicella Vaccine
Trade Names
  • Varicella: Varivax
  • Measles, mumps, and rubella (MMR) + varicella (MMRV): ProQuad
Indications
Administration Administer according to the CDC Immunization Schedule for all adults
Revaccination None
Comments
  • Contraindicated for patients with CD4 counts <200 cells/mm3 (see the CDC Immunization Schedule)
  • Anti-varicella IgG screening should be performed in patients with no known history of chickenpox or shingles [Marin, et al. 2007]
  • MMRV should not be used [Rubin, et al. 2014]
  • Antiherpetic agents should be avoided at least 24 hours before and 14 days after administration [Ezeanolue, et al. 2019]
  • An interval of at least 3 months is recommended between administration of post-exposure varicella IgG (VariZIG) and varicella vaccination [Cohn, et al. 2013]
  • Clinical disease due to varicella after vaccination, a very rare event, should be treated with acyclovir [AIDSinfo 2019]
  • Covered by the Vaccine Injury Compensation Program

Discussion: Patients with HIV who have CD4 counts ≥200 cells/mm3 and do not have immunity to varicella should be vaccinated according to CDC guidelines for all adults, with 2 doses of single-antigen varicella vaccine 4 to 8 weeks apart or a second dose if they have received only 1 dose. Varicella vaccination contains live virus and is contraindicated for patients with CD4 counts <200 cells/mm3 because of the risk of disseminated disease [Kramer, et al. 2001; Marin, et al. 2007; CDC 2019]. Data on the effectiveness of varicella vaccination among adults with HIV are lacking, but vaccination has been shown to be effective among children with HIV [Marin, et al. 2007; CDC 2012; Crum-Cianflone and Wallace 2014].

Clinicians should verify varicella immunity due to the possibility of severe disease in individuals with HIV. Birth before 1980 is not accepted as evidence of immunity in immunocompromised persons; anti-varicella IgG screening should be performed in patients with HIV who have no known history of chickenpox or shingles [Marin, et al. 2007]. Post-vaccination serologic testing to determine immune response is not recommended because commercially available assays lack sensitivity and may give false-negative results [Marin, et al. 2007]. Clinical disease due to varicella after vaccination, a very rare event, should be treated with acyclovir [Marin, et al. 2007; AIDSinfo 2019]. If household members or close contacts develop a rash after vaccination, individuals with HIV should avoid contact with the affected person until after the rash resolves [Marin, et al. 2007; Rubin, et al. 2014; Ezeanolue, et al. 2019]. Because they can interfere with vaccine virus replication and decrease vaccine effectiveness, all antiherpetic agents should be avoided for at least 72 hours before varicella vaccination through 14 days after [CDC 2016]. If post-exposure varicella immune globulin is given, clinicians should wait at least 5 months before vaccination [Ezeanolue, et al. 2019].

References

AIDSinfo. Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. 2019 https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/whats-new-guidelines [accessed 2019 Nov 26]

CDC. FDA approval of an extended period for administering VariZIG for postexposure prophylaxis of varicella. MMWR Morb Mortal Wkly Rep 2012;61(12):212. [PMID: 22456121]

CDC. Varicella. Epidemiology and prevention of vaccine-preventable diseases. 2016 Dec 30. https://www.cdc.gov/vaccines/pubs/pinkbook/index.html [accessed 2018 Mar 27]

CDC. Immunization schedules. 2019 https://www.cdc.gov/vaccines/schedules/hcp/adult.html [accessed 2019 Dec 2]

Cohn AC, MacNeil JR, Clark TA, et al. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2013;62(Rr-2):1-28. [PMID: 23515099]

Crum-Cianflone NF, Wallace MR. Vaccination in HIV-infected adults. AIDS Patient Care STDS 2014;28(8):397-410. [PMID: 25029589]

Ezeanolue E, Harriman K, Hunter P, et al. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP). 2019 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf [accessed 2019 Dec 2]

Kramer JM, LaRussa P, Tsai WC, et al. Disseminated vaccine strain varicella as the acquired immunodeficiency syndrome-defining illness in a previously undiagnosed child. Pediatrics 2001;108(2):E39. [PMID: 11483849]

Marin M, Guris D, Chaves SS, et al. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56(Rr-4):1-40. [PMID: 17585291]

Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis 2014;58(3):e44-100. [PMID: 24311479]

Zoster

Medical Care Criteria Committee; December 2019, reviewed and updated December 2021

Table 19: Zoster Vaccine
Trade Names Shingrix: Recombinant zoster vaccine (RZV), adjuvanted—PREFERRED
Indications

Medical Care Criteria Committee recommendation: Patients with HIV ≥18 years old (A2); updated December 2021 per Advisory Committee on Immunization Practices (ACIP) approval

Administration
  • Two IM doses, spaced 2 to 6 months apart, regardless of past receipt of zoster live vaccine (ZVL)
  • RZV is preferred over ZVL [Dooling, et al. 2018] (A2)
  • Perform anti-varicella immunoglobulin G (IgG) screening in patients with no known history of chickenpox or shingles
Comments
  • RZV provides strong protection against shingles and post-herpetic neuralgia. Currently, there are no data on immunogenicity specific to people with HIV; however, superior efficacy and longer duration of protection have been demonstrated among the elderly, and a recombinant vaccine is preferred people with HIV
  • ZVL (brand name Zostavax) is also available but is not recommended for people with HIV and is contraindicated in patients with CD4 count <200 cells/mm3 (see Centers for Disease Control and Prevention [CDC] guidelines). If RZV is not available and ZVL must be administered:
    • Perform anti-varicella IgG screening in patients with no known history of chickenpox or shingles
    • Instruct patients to avoid antiherpetic agents for 1 to 2 days before vaccination through 14 days after [Marin, et al. 2007]
    • Separate administration of ZVL from administration of pneumococcal vaccine by at least 4 weeks [FDA 2018]

Discussion: People with HIV are at increased risk of zoster (initial episodes and recurrences) at all stages of HIV disease; the risk is greater among those with severe immunodeficiency and lower CD4 cell counts [Harpaz, et al. 2008; Blank, et al. 2012]. Zoster vaccination may reduce disease burden in individuals with HIV; however, data on the use of zoster vaccine among adults with HIV are limited.

In October 2021, the ACIP approved a recommendation for 2 doses of RZV to prevent herpes zoster in adults >19 years old who are immunosuppressed; the previous recommendation was for vaccination of adults ≥50 years old. On December 1, 2021, the Medical Care Criteria Committee updated its recommendation as well: Adults with HIV ≥18 years old should receive 2 doses of RZV, administered 2 to 6 months apart. RZV provides strong protection against shingles and post-herpetic neuralgia. There is no specific data on immunogenicity in people with HIV; however, superior efficacy and longer duration of seroprotection have been demonstrated in the elderly, and a recombinant vaccine is preferred over a live, attenuated vaccine in this population [Dooling, et al. 2018].

Limited data are available on the immunogenicity of live, attenuated zoster vaccine in people with HIV (ZVL). The Committee does not recommend use of ZVL in people with HIV because of the potential for adverse effects and for interference by co-administered antiviral and immunoglobulin therapy [Benson, et al. 2018; Shafran 2016]. If ZVL is used due to lack of access to RZV, CDC guidelines recommend that, if possible, antiherpetic agents should be avoided 1 to 2 days before through 14 days after administration of the zoster vaccine [Harpaz, et al. 2008]. In addition, zoster vaccine should be separated from pneumococcal vaccine by at least 4 weeks [FDA 2018]. Anti-varicella IgG screening should be performed in patients with no known history of chickenpox or shingles. Zoster vaccination is contraindicated for patients with CD4 counts <200 cells/mm3 [Harpaz, et al. 2008]. There is no recommendation for post-vaccination serologic testing to determine immune response [Harpaz, et al. 2008].

References

Benson CA, Andersen JW, Macatangay BJC, et al. Safety and immunogenicity of zoster vaccine live in human immunodeficiency virus-infected adults with CD4+ cell counts >200 cells/mL virologically suppressed on antiretroviral therapy. Clin Infect Dis 2018;67(11):1712-1719. [PMID: 29590326

Blank LJ, Polydefkis MJ, Moore RD, et al. Herpes zoster among persons living with HIV in the current antiretroviral therapy era. J Acquir Immune Defic Syndr 2012;61(2):203-207. [PMID: 22766968]

FDA. Zostavax (zoster vaccine live). 2018 Aug. https://www.fda.gov/media/82524/download [accessed 2022 Oct 13]

Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR Morb Mortal Wkly Rep 2018;67(3):103-108. [PMID: 29370152]

Harpaz R, Ortega-Sanchez IR, Seward JF. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(Rr-5):1-30; quiz CE32-34. [PMID: 18528318]

Marin M, Guris D, Chaves SS, et al. Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56(Rr-4):1-40. [PMID: 17585291]

Shafran SD. Live attenuated herpes zoster vaccine for HIV-infected adults. HIV Med 2016;17(4):305-310. [PMID: 26315285]

Summary of Recommended Vaccines for Adults With HIV

Medical Care Criteria Committee; December 2019, updated October 2022

Click here to download full PDF version of the below table

Updates

October 5, 2022

  • Pneumococcal: Comprehensive update to Pneumococcal section.

July 2022

January 2022

December 2021

  • Zoster vaccine: Indication updated to patients with HIV ≥18 years old (A2)

July 2021

February 2021

  • Td vaccine: Change to revaccination section: “Td is usually given as a booster dose every 10 years, but it can also be given earlier after a severe and dirty wound or burn”
  • Varicella vaccine:
    • Insertion to indications section: “HIV-infected children ≥12 months old with CD4+ T-lymphocyte percentages ≥15%”
    • Change to comment section (in red): “An interval of at least 3 months is recommended between administration of post-exposure varicella IgG (VariZIG) and varicella vaccination”

December 2019

  • HAV vaccine: Indication updated to all individuals with HIV ≥1 year of age [CDC 2019a].
  • References updated throughout the document.

June 2018

Zoster vaccine: Changes/insertions made on June 4, 2018, are indicated in red, below.

  • RZV provides strong protection against shingles and post-herpetic neuralgia. Currently, there are no data on efficacy immunogenicity specific to people with HIV; however, superior efficacy and longer duration of protection have been demonstrated among the elderly, and a recombinant vaccine is preferred people with HIV. In addition, immunogenicity and safety following a 3-dose schedule has been demonstrated among people with HIV infection [Berkowitz et al. 2015]. 
  • Note: RZV is administered IM in distinction to ZVL which is delivered by SQ injection [Shimabukuro et al. 2018] 
  • Two references added June 4, 2018:
    • Berkowitz EM, Moyle G, Stellbrink HJ, Schürmann D, Kegg S, El Idrissi M, Oostvogeis L, Heineman TC, Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomizedplacebo-controlled studyJ Infect Dis. 2015 Apr 15;211(8):1279-87. [PMID: 25371534]
    • Shimabukuro TT, Miller ER, Strikas RA, et al. Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017–2018. MMWR Morb Mortal Wkly Rep 2018;67:585–586. [PMID: 29795075]