Immunizations for Adults With HIV

June 08, 2023

Purpose of This Guideline

Date of current publication: June 8, 2023
Lead authors: Christine Kerr, MD; Mary Dyer, MD
Contributor: Marguerite A. Urban, MD
Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Lyn C. Stevens, MS, NP, ACRN; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH
Committee: Medical Care Criteria Committee
Date of original publication: December 15, 2022

This compendium of immunization recommendations for adults (≥18 years) with HIV was compiled by the New York State Department of Health AIDS Institute (NYSDOH AI) to assist clinical practitioners in New York State who provide primary care to adults with HIV. The goal is to present a single compilation of all routine vaccinations for adults with HIV recommended by the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), HIV Medicine Association (HIVMA) DHHS 2022, and the Infectious Disease Society of America Thompson, et al. 2021. The European AIDS Clinical Society guidelines were also consulted EACS 2021. Where a recommendation differs from these source documents, the rationale is provided.

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.

Considerations and Contraindications

RECOMMENDATION

Immunizations

The tables and accompanying discussion in this guideline compile recommendations, vaccination schedules, clinical comments, and sources from the Centers for Disease Control and Prevention (CDC), National Institutes of Health, and HIV Medicine Association guidelines DHHS 2022, the Infectious Diseases Society of America Thompson, et al. 2021, and the European AIDS Clinical Society EACS 2021.

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 Thompson, et al. 2021Crum-Cianflone and Wallace 2014. However, there is concern that individuals 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 adults with advanced HIV, especially those with CD4 counts <200 cells/mm3 and/or HIV RNA levels (viral loads) ≥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.

Inactivated vaccines are generally considered safe, although data are insufficient to rule out rare adverse effects ACIP 2022Thompson, et al. 2021. 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 CDC 1996Redfield, et al. 1987CDC 1985Davis, et al. 1977. 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 POINTS: USE OF LIVE, ATTENUATED VACCINES
  • Individuals 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.
  • Individuals 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. Those who lack varicella immunity should avoid direct contact with people who develop rash.

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 Kolber, et al. 2002Rey, et al. 2000. The changes are less likely to occur in patients taking antiretroviral therapy and have not been found to have long-term negative effects Thompson, et al. 2021Sullivan, et al. 2000. 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 RNA level (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 Thompson, et al. 2021Grohskopf, et al. 2019Fiore, et al. 2011. Live, attenuated virus vaccines may be safely administered to close contacts of individuals with HIV, with specific precautions for varicella and rotavirus vaccines. Transmission of live, attenuated virus after vaccination is rare Thompson, et al. 2021. However, patients with HIV who lack varicella immunity are advised to avoid direct contact with people who develop a rash after varicella or zoster vaccination. Thompson, et al. 2021Fiore, et al. 2011Cortese and Parashar 2009Marin, et al. 2007.

The tables in this guideline (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.

Resource
  • Tel: 1-800-338-2382
  • Website: gov/vaccinecompensation
  • Address to file a claim: US Court of Federal Claims, 717 Madison Place NW, Washington, DC 20439

COVID-19

Abbreviations: CDC, Centers for Disease Control and Prevention; FDA, U.S. Food and Drug Administration.

Note:

  1. As of May 6, 2023, the J&J/Janssen viral vector COVID-19 vaccine is no longer available for use in the United States (see CDC: Overview of COVID-19 Vaccines).
Table 1a: COVID-19 Vaccines
Trade Names
See FDA: COVID-19 Vaccines Authorized for Emergency Use or FDA-Approved
  • Moderna COVID-19 Vaccine, Bivalent (mRNA vaccine)
  • Pfizer-BioNTech COVID-19 Vaccine, Bivalent (mRNA vaccine)
  • Novavax COVID-19 Vaccine, Adjuvanted (protein subunit vaccine)
  • Janssen (Johnson & Johnson) COVID-19 Vaccine (adenovirus vector vaccine) [a]
Indications At least 1 bivalent mRNA COVID-19 vaccine for all individuals ≥6 months old
Administration Administer according to CDC: COVID-19 Vaccination Schedule:

  • Table 1: Recommended COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised by COVID-19 vaccination history, May 2023
  • Table 2: Recommended COVID-19 vaccination schedule for people who are moderately or severely immunocompromised by COVID-19 vaccination history, May 2023
Comments See CDC: COVID-19 Vaccination Schedule for the following additional information:

  • Description of moderate and severe immunocompromising conditions and treatments
  • Considerations for individuals ≥65 years old to receive an additional bivalent mRNA dose

Download Table 1a: COVID-19 Vaccines Printable PDF

Universal vaccination: To reduce community transmission and protect individuals with HIV, this committee agrees with the CDC recommendations for universal vaccination against COVID-19 for adults (≥18 years old) with HIV, regardless of prior history of COVID-19 infection. This committee also agrees with the CDC’s recommendation that people with HIV with active viremia or with a CD4 count <200 cells/mm3 should be vaccinated as per the CDC’s schedule for moderately or severely immunocompromised patients. Schedules for all patients include at least 1 bivalent vaccination dose, even if they have completed a monovalent vaccine dosing schedule.

The available vaccines against SARS-CoV-2 have strong evidence both for safety and efficacy in preventing severe disease and death Grana, et al. 2022. Additionally, many people with HIV have multiple risk factors for severe COVID-19 infection. For more information, see:

Abbreviations: CDC, Centers for Disease Control and Prevention; J&J, Johnson & Johnson.

Notes:

  1. COVID-19 vaccination is recommended regardless of history of SARS-CoV-2 infection. Defer any COVID-19 vaccination at least until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met. If SARS-CoV-2 infection was recent, may consider delaying a COVID-19 vaccine dose by 3 months from symptom onset or positive test result (if infection was asymptomatic). Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection is not recommended for the purpose of vaccine decision-making (see CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States > COVID-19 vaccination and SARS-CoV-2 infection).
  2. An 8-week interval between the first and second doses of Moderna and Pfizer-BioNTech COVID-19 vaccines might be optimal for some people ages 6 months to 64 years, especially for males ages 12 to 39 years, as it might reduce the small risk of myocarditis and pericarditis associated with these vaccines.
  3. As of May 6, 2023, the J&J/Janssen viral vector COVID-19 vaccine is no longer available for use in the United States (see CDC: Overview of COVID-19 Vaccines).
Table 1b: Recommended COVID-19 Vaccination Schedule for Individuals ≥12 Years Old Who Are NOT Moderately or Severely Immunocompromised, May 2023 (Adapted from CDC: COVID-19 Vaccination Schedule Table 1)
COVID-19 Vaccination History Recommendation [a] Optional
Unvaccinated 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent vaccine Individuals ≥65 years old have the option to receive 1 additional bivalent mRNA vaccine dose ≥4 months after first dose of a bivalent mRNA vaccine.
≥1 dose of monovalent mRNA vaccine; no previous doses of bivalent mRNA vaccine
  • 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent vaccine
  • Administer bivalent vaccine ≥8 weeks [b] after last monovalent dose.
Any previous dose(s) of bivalent mRNA vaccine, regardless of monovalent vaccine history Vaccination is complete.
≥1 dose of Novavax vaccine
  • 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent vaccine
  • Administer bivalent vaccine ≥8 weeks [b] after last monovalent dose.
≥1 dose of J&J/Janssen vaccine (individuals ≥18 years old) [c]
  • 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent
  • Note: Administer bivalent vaccine ≥2 months after completion of the primary series dose (for people who have not previously received any booster doses) or ≥2 months after the last monovalent booster dose.

Download Table 1b: Recommended COVID-19 Vaccination Schedule for Individuals ≥12 Years Old Who Are NOT Moderately or Severely Immunocompromised, May 2023 Printable PDF

Abbreviations: CDC, Centers for Disease Control and Prevention; J&J, Johnson & Johnson.

Notes:

  1. See CDC: Description of moderate and severe immunocompromising conditions and treatment.
  2. COVID-19 vaccination is recommended regardless of history of SARS-CoV-2 infection. Defer any COVID-19 vaccination at least until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met. If SARS-CoV-2 infection was recent, may consider delaying a COVID-19 vaccine dose by 3 months from symptom onset or positive test result (if infection was asymptomatic). Viral testing to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection is not recommended for the purpose of vaccine decision-making (see CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States > COVID-19 vaccination and SARS-CoV-2 infection).
  3. Further additional dose(s) may be administered, informed by the clinical judgement of a healthcare provider and personal preference and circumstances of the patient. Any further additional doses should be administered ≥2 months after the last COVID-19 vaccine dose.
  4. As of May 6, 2023, the J&J/Janssen viral vector COVID-19 vaccine is no longer available for use in the United States (see CDC: Overview of COVID-19 Vaccines).
Table 1c: Recommended COVID-19 Vaccination Schedule for Individuals ≥12 Years Old Who ARE Moderately or Severely Immunocompromised [a], May 2023 (Adapted from CDC: COVID-19 Vaccination Schedule Table 2)
COVID-19 Vaccination History Recommendation [b] Interval Between Doses
Unvaccinated 3 doses of Moderna bivalent vaccine OR 3 doses of Pfizer-BioNTech bivalent vaccine
  • Moderna: 4 weeks between dose 1 and dose 2; ≥4 weeks between dose 2 and dose 3
  • Pfizer-BioNTech: 3 weeks between dose 1 and dose 2; ≥4 weeks between dose 2 and dose 3
1 dose of monovalent Moderna vaccine 2 doses of Moderna bivalent vaccine
  • Bivalent dose 1: 4 weeks after monovalent dose
  • Bivalent dose 2: ≥4 weeks after bivalent dose 1
2 doses of monovalent Moderna vaccine 1 dose of Moderna bivalent vaccine ≥4 weeks after last monovalent dose
3 doses of monovalent Moderna vaccine 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent vaccine ≥8 weeks after last monovalent dose
3 doses of monovalent Moderna vaccine and 1 dose of bivalent mRNA vaccine Optional: 1 additional dose of Moderna bivalent vaccine OR Pfizer-BioNTech bivalent vaccine [c] ≥2 months after last bivalent mRNA vaccine dose
1 dose of monovalent Pfizer-BioNTech vaccine 2 doses of Pfizer-BioNTech bivalent vaccine
  • Bivalent dose 1: 3 weeks after monovalent dose
  • Bivalent dose 2: ≥4 weeks after bivalent dose 1
2 doses of monovalent Pfizer-BioNTech vaccine 1 dose of Pfizer-BioNTech bivalent vaccine ≥4 weeks after last monovalent dose
3 doses of monovalent Pfizer-BioNTech vaccine 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent vaccine ≥8 weeks after last monovalent dose
3 doses of monovalent Pfizer-BioNTech vaccine and 1 dose of bivalent mRNA vaccine Optional: 1 additional dose of Moderna bivalent vaccine OR Pfizer-BioNTech bivalent vaccine [c] ≥2 months after last bivalent mRNA vaccine dose
1 or 2 doses of Novavax vaccine 1 dose of Moderna bivalent vaccine OR 1 dose of Pfizer-BioNTech bivalent vaccine ≥8 weeks after last monovalent dose
1 dose of J&J/Janssen vaccine (individuals ≥18 years old) [d] 1 or 2 doses of Moderna bivalent vaccine OR Pfizer-BioNTech bivalent vaccine
  • Dose 1: ≥4 weeks after last monovalent dose
  • Dose 2 (optional): ≥2 months after the recommended bivalent mRNA vaccine dose
1 dose of J&J/Janssen vaccine (individuals ≥18 years old) [d] and 1 dose of Moderna bivalent vaccine OR Pfizer-BioNTech bivalent vaccine Optional: 1 dose of Moderna bivalent vaccine OR Pfizer-BioNTech bivalent vaccine [c] ≥2 months after the previous bivalent mRNA vaccine dose

Download Table 1c: Recommended COVID-19 Vaccination Schedule for Individuals ≥12 Years Old Who ARE Moderately or Severely Immunocompromised, May 2023 Printable PDF

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. 2021Costenaro, et al. 2021Mirzaei, et al. 2021Patel, et al. 2021Tesoriero, et al. 2021Cooper, et al. 2020Nandy, et al. 2020Ssentongo, et al. 2020. Although 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 time of hospital admission and an in-hospital mortality rate of 23.1% for people with HIV WHO 2021. Because there is also 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. 2021Patel, et al. 2021Ssentongo, et al. 2021Byrd, et al. 2020.

COVID-19 vaccines have 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. Myocarditis has been reported mostly among young men, mostly after the second dose of an mRNA vaccine, and has been mostly mild with spontaneous resolution (see CDC: Myocarditis and Pericarditis Considerations).

COVID-19 vaccines have been shown to be safe and effective in people with HIV Yin, et al. 2022. There has been no evidence of decreased vaccine efficacy and no reports of increased vaccine adverse effects in people with HIV, although antibody response may peak later and wane earlier Fowokan, et al. 2023Chambers, et al. 2022. However, individuals with HIV and a CD4 count <350 cells/mm3 are at high risk for breakthrough infection and should receive vaccination as per the schedule for patients who are immunocompromised Lang, et al. 2022.

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.

Haemophilus influenzae Type B (Hib)

Abbreviations: CDC, Centers for Disease Control and Prevention; Hib, Haemophilus influenzae type B.
Table 2: Haemophilus influenzae Type B Vaccine
Trade Names
  • Hiberix
  • ActHIB
Indications Patients at risk of Hib infection
Administration Administer according to CDC: Adult Immunization Schedule:

  • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
  • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
Revaccination None
Comments Not routinely recommended for people with HIV in the absence of other risk factors

Download Table 2: Haemophilus influenzae Type B Vaccine Printable PDF

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 Hib infection in adults with HIV CDC 2023Thompson, et al. 2021Briere, et al. 2014. 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 MacLennan, et al. 2016Dockrell, et al. 1999Kroon, et al. 1997Steinhoff, et al. 1991.

Hepatitis A Virus (HAV)

Abbreviations: CDC, Centers for Disease Control and Prevention; HAV, hepatitis A virus; HBV, hepatitis B virus; HRSA, Health Resources and Services Administration; IgG, immunoglobulin G.
Table 3: Hepatitis A Virus Vaccine
Trade Names
  • HAV: Havrix; Vaqta
  • HAV inactivated + HBV: Twinrix
Indications All adults with HIV CDC(a) 2022
Administration
  • Administer according to CDC: Adult Immunization Schedule:
    • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
    • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
  • Notes:
    • Obtain HAV IgG testing ≥1 month after final dose of vaccination series to confirm immune response.
    • If immune reconstitution appears likely, consider deferring until patient’s CD4 count ≥200 cells/mm3 DHHS 2022.
Revaccination Patients who do not respond to the primary HAV vaccination series should be revaccinated Thompson, et al. 2021 and counseled to avoid exposure.
Comments

Download Table 3: Hepatitis A Virus Vaccine Printable PDF

Discussion: The HAV vaccine is recommended for all adults with HIV who do not have immunity to HAV CDC(a) 2022Thompson, et al. 2021.

The reported rate of HAV antibody seroconversion after vaccination ranges from 49% to 96% Mena, et al. 2015Crum-Cianflone and Wallace 2014Fiore, et al. 2006. 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 Cheng, et al. 2017Crum-Cianflone(b), et al. 2011. 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 Mena, et al. 2015Crum-Cianflone and Wallace 2014Fiore, et al. 2006.

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 DHHS 2022. HAV vaccination should not be deferred in patients who are unlikely to achieve an increased CD4 cell count.

Care providers should perform HAV immunoglobulin G (IgG) testing at least 1 month after the final dose of the vaccination series to confirm immune response. HAV vaccination should be repeated in patients with no response to initial vaccination, Thompson, et al. 2021, and they should be counseled to avoid exposure to HAV because they remain susceptible to infection, although a small study reported that 31% of participants who had not seroconverted at month 12 and before month 18 (n = 16) subsequently seroconverted after completing the 2-dose vaccination series Cheng, et al. 2017. If a patient is susceptible to both HAV and HBV, the combined HAV/HBV vaccine (given as 3 doses at 0, 1, and 6 months) can be used regardless of the patient’s immune status Thompson, et al. 2021.

Hepatitis B Virus (HBV)

Abbreviations: anti-HBs, hepatitis B surface antibody; CDC, Centers for Disease Control and Prevention; FDA, U.S. Food and Drug Administration; HAV, hepatitis A virus; HBV, hepatitis B virus; HRSA, Health Resources and Services Administration.
Table 4: Hepatitis B Virus Vaccine
Trade Names
  • HBV 2-dose series: HEPLISAV-B (see comments)
  • HBV 3-dose series: Engerix-B; Recombivax HB; PreHevbrio (see comments)
  • HAV inactivated + HBV 3-dose series: Twinrix
Indications Patients who are negative for anti-HBs and do not have chronic HBV infection
Administration
  • Administer according to CDC: Adult Immunization Schedule:
    • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
    • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
  • Notes:
    • 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 DHHS 2022.
    • Test for anti-HBs 4 to 16 weeks after administration of the last dose of the vaccination series.
Revaccination Patients who do not respond to the primary HBV vaccination series (anti-HBs <10 IU/L) should be revaccinated with Heplisav-B or a double dose of the vaccine series previously administered.
Comments
  • In patients at risk for HBV infection, initial vaccination should not be deferred if the CD4 count is <200 cells/mm3 DHHS 2022.
  • If an accelerated schedule is used, a fourth booster dose should be administered ≥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.
  • PreHevbrio, a 3-antigen recombinant HBV vaccine, was approved in 2021 by the FDA for use for individuals ≥18 years old FDA 2021, but experience regarding its use in patients with HIV is lacking at this time.
  • Heplisav-B and PreHevbrio are not recommended in pregnancy because of lack of safety data CDC 2023.
  • See NYSDOH AI guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV.
  • Covered by HRSA: Vaccine Injury Compensation Program

Download Table 4: Hepatitis B Virus Vaccine Printable PDF

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 2023. The antibody response to the HBV vaccine is reduced in individuals 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% Mena, et al. 2015Mast, et al. 2006, with diminishing response with lower CD4 cell counts Pollack, et al. 2016Pettit, et al. 2010Kim, et al. 2008Overton, et al. 2005. Undetectable or very low viral load is associated with increased response to HBV vaccination Mena, et al. 2015Kim, et al. 2008Overton, et al. 2005. 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 DHHS 2022Whitaker, et al. 2012.

The 3 single-antigen HBV vaccines currently approved by the FDA for individuals ≥18 years old are Engerix-B, Recombivax HB, and Heplisav-B. PreHevbrio, a 3-antigen recombinant HBV vaccine, was approved in 2021 by the FDA for use for individuals ≥18 years old FDA 2021, but experience regarding its use in patients with HIV is lacking at this time.

In 3 randomized controlled trials among individuals without HIV, administration of 2 doses of Heplisav-B was associated with a higher seroprotection rate than 3 doses of Engerix-B FDA(b) 2020. However, the 3 formulations have not yet been established to be equally effective in patients with HIV. A retrospective cohort study among individuals with HIV found seroprotection rates were increased with the Heplisav-B vaccine compared with other previously used HBV vaccines Schnittman, et al. 2021. In addition, a recent modeling study determined that use of Heplisav-B among individuals with HIV results in lower costs and increased benefits compared with Engerix-B Rosenthal, et al. 2020. The 2-dose option may facilitate completion rates for the vaccination series.

Improved immune response has been reported using a 4-injection double-dose (40 µg) regimen Chaiklang, et al. 2013Launay, et al. 2011. Studies of a 3-injection double-dose regimen reported increased seroconversion rates compared with standard dose only among adults with HIV with CD4 counts >350 cells/mm3 and low or undetectable HIV viral load Potsch, et al. 2012Fonseca, et al. 2005. 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 because of the increased likelihood of nonresponse de Vries-Sluijs, et al. 2011. Patients with HIV should be tested for anti-HBs 4 to 16 weeks after completing the vaccination series DHHS 2022Thompson, et al. 2021. Other strategies to improve immune response have demonstrated some success, including intradermal administration Launay, et al. 2011 and addition of adjuvants Overton, et al. 2010Cooper, et al. 2005Sasaki, et al. 2003, but the evidence is not sufficient to make a recommendation.

Patients who do not respond to primary vaccination should be revaccinated with Heplisav-B or a double dose of the vaccine series previously administered. In a recent retrospective, cross-sectional study among individuals with HIV who failed to seroconvert after vaccination (anti-HBs negative and hepatitis B surface antigen negative) with Engerix-B or Recombivax HB, revaccination with Heplisav-B was highly effective in achieving seroprotection Khaimova, et al. 2021. If Heplisav-B is not administered as the initial HBV vaccination series, revaccination with the 2-dose series may be considered. Several studies have reported increased response rates from double-dose revaccination Psevdos, et al. 2010Cardell, et al. 2008de Vries-Sluijs, et al. 2008, 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. In patients who do not have an immune response to HBV vaccination and are initiating antiretroviral therapy, revaccination can be deferred until the CD4 count increases to ≥200 cells/mm3 DHHS 2022. Revaccination should not be delayed in patients who are unlikely to achieve an increased CD4 cell count.

For people 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 individuals with HIV, the combined vaccine is not recommended for the double-dose or 4-injection HBV vaccination strategy.

Human Papillomavirus (HPV)

Abbreviations: CDC, Centers for Disease Control and Prevention; HPV, human papillomavirus; HRSA, Health Resources and Services Administration.
Table 5: Human Papillomavirus Vaccine
Trade Name Gardasil 9
Indications All patients 9 to 45 years old who were not previously vaccinated or did not receive a complete 3-dose series
Administration Administer through age 45 years as a 3-dose series according to CDC: Adult Immunization Schedule:

  • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
  • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
Revaccination None
Comments

Download Table 5: Human Papillomavirus Vaccine Printable PDF

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(a) 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(a) 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. 2018Kojic, 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(a) 2021.

Influenza

Table 6: Influenza Vaccine
Abbreviation: CDC, Centers for Disease Control and Prevention; HRSA, Health Resources and Services Administration.
Trade Names See CDC influenza vaccines table
Indications All adults with HIV
Administration Administer annually during flu season (October through May) according to CDC: Adult Immunization Schedule:

  • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
  • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
Revaccination None
Comments Covered by HRSA: Vaccine Injury Compensation Program

Download Table 6: Influenza Vaccine Printable PDF

Discussion: People with HIV are at greater risk of severe morbidity from an influenza infection Grohskopf, et al. 2019Kunisaki and Janoff 2009 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 Thompson, et al. 2021Grohskopf, et al. 2019. Inactivated influenza vaccine offers protective immunity in adults with HIV Grohskopf, et al. 2019Remschmidt, et al. 2014Beck, et al. 2012. 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 ≥35 years old, have low CD4 cell counts, and have detectable viremia Garg, et al. 2016Crum-Cianflone(a), et al. 2011Evison, et al. 2009Yamanaka, et al. 2005Kroon, et al. 2000. 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. 2016Seo, 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 ≥18 years old who are given a double-dose vaccine than for those given the standard dose vaccine, but the clinical significance of this remains unknown McKittrick, et al. 2013Cooper, et al. 2011. A study among children and young adults (3 to 21 years old) found no increased immunity among participants with HIV who received the double-dose vaccine Hakim, et al. 2016.

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 Glinka, et al. 2016Werker, et al. 2014. 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.

Measles, Mumps, Rubella (MMR)

Abbreviations: CDC, Centers for Disease Control and Prevention; HRSA, Health Resources and Services Administration; MMR, measles, mumps, rubella.
Table 7: Measles, Mumps, Rubella Vaccine
Trade Names M-M-R II
Indications For patients with CD4 counts ≥200 cells/mm3 for ≥6 months who do not have evidence of MMR immunity
Administration Administer according to CDC: Adult Immunization Schedule:

  • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
  • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
Revaccination Recommended only in the setting of an outbreak
Comments
  • Contraindicated for patients with CD4 counts <200 cells/mm3
  • The MMR + varicella vaccine (ProQuad) should not be substituted for the MMR vaccine McLean, et al. 2013.
  • 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 HRSA: Vaccine Injury Compensation Program

Download Table 7: Measles, Mumps, Rubella Vaccine Printable PDF

Discussion: Immunocompromised individuals 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 for ≥6 months and who do not have evidence of immunity to MMR should be vaccinated with 2 doses of MMR vaccine ≥4 weeks 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, individuals with perinatally acquired HIV who received childhood vaccination with MMR before establishment of effective antiretroviral therapy (ART) should be revaccinated (2 doses) after effective 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 MMR vaccination. 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 Abzug, et al. 2012Aurpibul, et al. 2007. If individuals previously vaccinated with 2 doses of a mumps-containing vaccine are identified as having 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 because of reports of adverse events, such as measles pneumonitis, in severely immunocompromised patients Angel, et al. 1998CDC 1996. Serious adverse effects have not been reported in adults who were not severely immunocompromised Chaiwarith, et al. 2016McLean, et al. 2013Belaunzaran-Zamudio, et al. 2009. The MMR + varicella vaccine has not been adequately studied in individuals with HIV and is not recommended as a substitute for the MMR vaccine in this population McLean, et al. 2013.

Meningococcal Serotypes A,C, W, and Y (MenACWY)

Abbreviations: CDC, Centers for Disease Control and Prevention; HRSA, Health Resources and Services Administration; MenACWY, meningococcal serotypes A,C, W, and Y.
Table 8: Meningococcal Serotypes A,C, W, and Y Vaccine
Trade Names
  • Menactra (MenACWY-D)
  • Menveo (MenACWY-CRM)
  • MenQuadfi (MenACWY-TT)
Indications All patients with HIV
Administration
  • Administer 2 doses of MenACWY vaccine ≥8 weeks apart in those not previously vaccinated.
  • For those previously vaccinated with 1 dose of MenACWY vaccine, administer the second dose at the earliest opportunity ≥8 weeks after the previous dose.
  • See CDC: Adult Immunization Schedule:
    • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
    • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
Revaccination Administer 1 booster dose of MenACWY vaccine every 5 years.
Comments

Download Table 8: Meningococcal Serotypes A,C, W, and Y Vaccine Printable PDF

Discussion: Adults with HIV are at increased risk of invasive meningococcal disease due to serogroups C, W, and Y Mbaeyi, et al. 2020Folaranmi, et al. 2017. A 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 2020, the CDC recommends vaccinating all previously unvaccinated adults with HIV with a 2-dose primary series of MenACWY vaccine (MenACWY-CRM, MenACWY-D, or MenACWY-TT) administered ≥8 weeks apart Mbaeyi, et al. 2020.

Data on meningococcal vaccine efficacy among adults with HIV are not currently available Mbaeyi, et al. 2020. 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 Lujan-Zilbermann, et al. 2012Siberry, et al. 2010. 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. There is no recommendation for post-vaccination serologic testing to determine immune response Mbaeyi, et al. 2020.

Meningococcal Serotype B (MenB)

Abbreviations: CDC, Centers for Disease Control and Prevention; HRSA, Health Resources and Services Administration; MenB, meningococcal serotype B.
Table 9a: MenB Vaccine for Prevention of MenB Infection
Trade Names
  • Bexsero (4CMenB)
  • Trumenba (MenB-FHbp)
Indications Patients at risk of MenB infection
Administration Administer according to CDC: Adult Immunization Schedule 2023: HTML | PDF
Revaccination None
Comments
  • Bexsero (4CMenB) and Trumenba (MenB-FHbp) are not interchangeable.
  • Not routinely recommended for people with HIV in the absence of other risk factors
  • Covered by HRSA: Vaccine Injury Compensation Program

Download Table 9a: MenB Vaccine for Prevention of MenB Infection Printable PDF

Discussion: The MenB vaccine offers protection against MenB infection. 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 2023.

Abbreviations: CDC, Centers for Disease Control and Prevention; MenB, meningococcal serotype B; MSM, men who have sex with men; STI, sexually transmitted infection.

Note:

  1. There are multiple ongoing clinical trials studying 4CMenB vaccination for the prevention of gonococcal infection utilizing a variety of dosing intervals and follow-up periods. The DOXYVAC trial utilized the dosing regimen of 0 and 2 months Molina, et al. 2023. No data are currently available regarding revaccination. CDC: Adult Immunization Schedule and Bexsero package insert recommend a 2-dose regimen separated by at least 1 month when vaccinating for the prevention of MenB. 
Table 9b: MenB Vaccine for Prevention of Gonorrhea
Trade Name Bexsero (4CMenB)
Indications Patients at risk of gonorrhea infection, i.e., MSM and other individuals who have had a bacterial STI in the prior 12 months, sex workers, and individuals engaging in condomless sex with multiple partners (A2†)
Administration 2 doses; first dose given at month 0 and second dose given at month 2 [a]
Revaccination None [a]
Comments Note: Bexsero (4CMenB) and Trumenba (MenB-FHbp) are not interchangeable

Download Table 9b: MenB Vaccine for Prevention of Gonorrhea Printable PDF

Discussion: The N. gonorrhoeae and N. meningitidis organisms are genetically similar and share many outer membrane proteins. In retrospective observational studies, MenB vaccination has been associated with 30% to 40% protection against gonorrhea infection Abara, et al. 2022Wang, et al. 2022Petousis-Harris, et al. 2017. The prospective randomized phase 3 DOXYVAC trial evaluated the use of 4CMenB vaccination dosed at 0 and 2 months for the prevention of gonococcal infection in men who have sex with men who had a history of a bacterial sexually transmitted infection in the prior year and were taking HIV pre-exposure prophylaxis. Preliminary data show a statistically significant increase in time to the first episode of gonorrhea among participants who received the 4CMenB vaccine. Because of the significant outcomes, enrollment in the trial was halted and all participants were offered 4CMenB vaccination Molina, et al. 2023. This committee finds the early evidence of protection against gonorrhea sufficient to recommend vaccination with 4CMenB vaccine (Bexsero) for adults at risk of acquiring gonorrhea. As results from ongoing clinical trials become available, the MCCC will review the findings and confirm or adjust recommendations in accordance with the evidence.

Note: Meningococcal A, C, W, Y vaccine (Menveo, MenQuadfi, Menactra) and MenB-FHbp (Trumenba) are not interchangeable with 4CMenB vaccine and would not be expected to offer protection against N. gonorrhoeae.

Mpox

RECOMMENDATIONS
Mpox Vaccine
  • Clinicians should recommend vaccination against mpox (formerly “monkeypox”) 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 cell count and degree of viral suppression. (A3)
Abbreviation: CDC, Centers for Disease Control and Prevention.

Note:

  1. See package insert and CDC: Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines During the 2022 U.S. Monkeypox Outbreak.
Table 10: 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 Individuals with HIV ≥18 years old who are at high risk of or who have been exposed to mpox within the past 14 days
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.

Download Table 10: Mpox Vaccine Printable PDF

Immunization: The 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(b) 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 Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines During the 2022 U.S. Monkeypox Outbreak).

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, but a fulminant form of mpox has been reported in people with advanced immunosuppression due to HIV Mitja, et al. 2023.

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 days after exposure, vaccination may not prevent disease but may reduce symptoms CDC(b) 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, but a fulminant form of mpox has been reported in people with advanced immunosuppression due to HIV Mitja, et al. 2023.

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

Pneumococcal

Abbreviation: CDC, Centers for Disease Control and Prevention.
Table 11: Pneumococcal Vaccine
(see also CDC: Adult Immunization Schedules: By Age [Table 1] and Medical Condition [Table 2]  and CDC: 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.
Revaccination Consult CDC: PneumoRecs VaxAdvisor
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.
  • The Menactra (MenACWY-D) vaccine for meningococcal serotype groups A,C, W, and Y (MenACWY) should not be administered until ≥4 weeks after pneumococcal conjugate vaccine.

Download Table 11: Pneumococcal Vaccine Printable PDF

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 2023Kobayashi, et al. 2022. Patients who have not previously been vaccinated or whose vaccination status is unknown should receive 1 dose of PCV15 or 1 dose of PCV20; if PCV15 is used, it should be followed with 1 dose of 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 2023Kobayashi, et al. 2022. See the CDC: PneumoRecs VaxAdvisor for vaccination recommendations by age and pneumococcal immunization history.

Pneumococcal vaccination has been shown to reduce pneumococcal bacteremia and mortality among adults with HIV Chowers, et al. 2017Rodriguez-Barradas, et al. 2008Grau, et al. 2005Hung, 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. 2016Bhorat, et al. 2015Rodriguez-Barradas, et al. 2015Ho, 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 2023.

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

Abbreviations: CDC, Centers for Disease Control and Prevention; HRSA, Health Resources and Services Administration; Tdap, tetanus, diphtheria, and pertussis; Td, tetanus-diphtheria.
Table 12: Tetanus, Diphtheria, and Pertussis and Tetanus-Diphtheria Vaccines
Trade Names
  • Tdap: Adacel; Boostrix
  • Td: Tenivac; TDVax
Indications All adult patients
Administration Administer according to CDC: Adult Immunization Schedule:

  • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
  • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
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 HRSA: Vaccine Injury Compensation Program

Download Table 12: Tetanus, Diphtheria, and Pertussis and Tetanus-Diphtheria Vaccines Printable PDF

Discussion: The recommendations for Tdap and Td vaccination of adults with HIV are the same as for those in the general population CDC 2023Thompson, et al. 2021. The safety and efficacy of vaccination with Tdap has not been studied in this population Crum-Cianflone and Wallace 2014.

Varicella

Abbreviations: CDC, Centers for Disease Control and Prevention; HRSA, Health Resources and Services Administration; IgG, immunoglobulin G; MMR, measles, mumps, rubella; VariZIG, varicella zoster immune globulin.
Table 13: Varicella Vaccine
Trade Names Varivax
Indications For patients with CD4 counts ≥200 cells/mm3 who do not have evidence of immunity to varicella
Administration Administer according to CDC: Adult Immunization Schedule:

  • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
  • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
Revaccination None
Comments

Download Table 13: Varicella Vaccine Printable PDF

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 administered 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 CDC 2023Marin, et al. 2007Kramer, et al. 2001. 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 Crum-Cianflone and Wallace 2014CDC 2012Marin, et al. 2007.

Because of the possibility of severe disease in individuals with HIV, clinicians should verify varicella immunity. Birth before 1980 is not accepted as evidence of immunity in immunocompromised individuals; anti-varicella immunoglobulin G 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 DHHS 2022Marin, et al. 2007. If household members or close contacts develop a rash after vaccination, people with HIV should avoid contact with the affected individual until after the rash resolves ACIP 2022Marin, et al. 2007. Because they can interfere with vaccine virus replication and decrease vaccine effectiveness, all antiherpetic agents should be avoided for at least 24 hours before varicella vaccination through 14 days after ACIP 2022CDC(b) 2021. If post-exposure varicella zoster immune globulin is given, clinicians should wait ≥5 months before varicella vaccination ACIP 2022DHHS 2022CDC 2006.

Zoster

Abbreviations: CDC, Centers for Disease Control and Prevention; IgG, immunoglobulin G; MCCC, Medical Care Criteria Committee; RZV, recombinant zoster vaccine; ZVL, zoster vaccine live.
Table 14: Zoster Vaccine
Trade Names Shingrix: RZV, adjuvanted
Indications MCCC recommendation: Patients with HIV ≥18 years old (A2)
Administration
  • Two intramuscular doses, given 2 to 6 months apart, regardless of past receipt of ZVL (brand name Zostavax)
  • Perform anti-varicella IgG screening in patients with no known history of chickenpox or shingles Marin, et al. 2007.
  • See CDC: Adult Immunization Schedule:
    • Recommendations for Ages 19 Years and Older, 2023: HTML | PDF (Table 1)
    • Recommendations by Medical Condition and Other Indication: HTML | PDF (Table 2)
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 for people with HIV Anderson, et al. 2022Dooling, et al. 2018.
  • As of November 2020, ZVL is no longer available for use in the United States.

Download Table 14: Zoster Vaccine Printable PDF

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 Blank, et al. 2012Harpaz, et al. 2008. Zoster vaccination may reduce disease burden in individuals with HIV; however, data on the use of zoster vaccine among adults with HIV are limited.

The Advisory Committee on Immunization Practices recommends 2 doses of recombinant zoster vaccine (RZV; brand name Shingrix) to prevent herpes zoster in adults ≥19 years old who are immunosuppressed Anderson, et al. 2022; the previous recommendation was for vaccination of adults ≥50 years old Dooling, et al. 2018. On December 1, 2021, the MCCC 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 Anderson, et al. 2022Dooling, et al. 2018. As of November 2020, the live, attenuated zoster vaccine (ZVL; brand name Zostavax) is no longer available for use in the United States.

Anti-varicella IgG screening should be performed in patients with no known history of chickenpox or shingles Marin, et al. 2007, and patients with a negative titer should be vaccinated for varicella if their CD4 count is >200 cells/mm3 as an initial step, and the series should be completed before zoster vaccination. There is no recommendation for post-vaccination serologic testing to determine immune response Harpaz, et al. 2008.

All Recommendations

ALL RECOMMENDATIONS: IMMUNIZATIONS FOR ADULTS WITH HIV

Download all vaccine tables

Immunizations

Mpox Vaccine
  • Clinicians should recommend vaccination against mpox (formerly “monkeypox”) 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 cell count and degree of viral suppression. (A3)

Abbreviations: CDC, Centers for Disease Control and Prevention; EUA, emergency use authorization; FDA, U.S. Food and Drug Administration.

Shared Decision-Making

Download Printable PDF of Shared Decision-Making Statement

Date of current publication: August 8, 2023
Lead authors:
Jessica Rodrigues, MS; Jessica M. Atrio, MD, MSc; and Johanna L. Gribble, MA
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 8, 2023

Rationale

Throughout its guidelines, the New York State Department of Health (NYSDOH) AIDS Institute (AI) Clinical Guidelines Program recommends “shared decision-making,” an individualized process central to patient-centered care. With shared decision-making, clinicians and patients engage in meaningful dialogue to arrive at an informed, collaborative decision about a patient’s health, care, and treatment planning. The approach to shared decision-making described here applies to recommendations included in all program guidelines. The included elements are drawn from a comprehensive review of multiple sources and similar  attempts to define shared decision-making, including the Institute of Medicine’s original description [Institute of Medicine 2001]. For more information, a variety of informative resources and suggested readings are included at the end of the discussion.

Benefits

The benefits to patients that have been associated with a shared decision-making approach include:

  • Decreased anxiety [Niburski, et al. 2020; Stalnikowicz and Brezis 2020]
  • Increased trust in clinicians [Acree, et al. 2020; Groot, et al. 2020; Stalnikowicz and Brezis 2020]
  • Improved engagement in preventive care [McNulty, et al. 2022; Scalia, et al. 2022; Bertakis and Azari 2011]
  • Improved treatment adherence, clinical outcomes, and satisfaction with care [Crawford, et al. 2021; Bertakis and Azari 2011; Robinson, et al. 2008]
  • Increased knowledge, confidence, empowerment, and self-efficacy [Chen, et al. 2021; Coronado-Vázquez, et al. 2020; Niburski, et al. 2020]

Approach

Collaborative care: Shared decision-making is an approach to healthcare delivery that respects a patient’s autonomy in responding to a clinician’s recommendations and facilitates dynamic, personalized, and collaborative care. Through this process, a clinician engages a patient in an open and respectful dialogue to elicit the patient’s knowledge, experience, healthcare goals, daily routine, lifestyle, support system, cultural and personal identity, and attitudes toward behavior, treatment, and risk. With this information and the clinician’s clinical expertise, the patient and clinician can collaborate to identify, evaluate, and choose from among available healthcare options [Coulter and Collins 2011]. This process emphasizes the importance of a patient’s values, preferences, needs, social context, and lived experience in evaluating the known benefits, risks, and limitations of a clinician’s recommendations for screening, prevention, treatment, and follow-up. As a result, shared decision-making also respects a patient’s autonomy, agency, and capacity in defining and managing their healthcare goals. Building a clinician-patient relationship rooted in shared decision-making can help clinicians engage in productive discussions with patients whose decisions may not align with optimal health outcomes. Fostering open and honest dialogue to understand a patient’s motivations while suspending judgment to reduce harm and explore alternatives is particularly vital when a patient chooses to engage in practices that may exacerbate or complicate health conditions [Halperin, et al. 2007].

Options: Implicit in the shared decision-making process is the recognition that the “right” healthcare decisions are those made by informed patients and clinicians working toward patient-centered and defined healthcare goals. When multiple options are available, shared decision-making encourages thoughtful discussion of the potential benefits and potential harms of all options, which may include doing nothing or waiting. This approach also acknowledges that efficacy may not be the most important factor in a patient’s preferences and choices [Sewell, et al. 2021].

Clinician awareness: The collaborative process of shared decision-making is enhanced by a clinician’s ability to demonstrate empathic interest in the patient, avoid stigmatizing language, employ cultural humility, recognize systemic barriers to equitable outcomes, and practice strategies of self-awareness and mitigation against implicit personal biases [Parish, et al. 2019].

Caveats: It is important for clinicians to recognize and be sensitive to the inherent power and influence they maintain throughout their interactions with patients. A clinician’s identity and community affiliations may influence their ability to navigate the shared decision-making process and develop a therapeutic alliance with the patient and may affect the treatment plan [KFF 2023; Greenwood, et al. 2020]. Furthermore, institutional policy and regional legislation, such as requirements for parental consent for gender-affirming care for transgender people or insurance coverage for sexual health care, may infringe upon a patient’s ability to access preventive- or treatment-related care [Sewell, et al. 2021].

Figure 1: Elements of Shared Decision-Making

Figure 1: Elements of Shared Decision-Making

Download figure: Elements of Shared Decision-Making

Health equity: Adapting a shared decision-making approach that supports diverse populations is necessary to achieve more equitable and inclusive health outcomes [Castaneda-Guarderas, et al. 2016]. For instance, clinicians may need to incorporate cultural- and community-specific considerations into discussions with women, gender-diverse individuals, and young people concerning their sexual behaviors, fertility intentions, and pregnancy or lactation status. Shared decision-making offers an opportunity to build trust among marginalized and disenfranchised communities by validating their symptoms, values, and lived experience. Furthermore, it can allow for improved consistency in patient screening and assessment of prevention options and treatment plans, which can reduce the influence of social constructs and implicit bias [Castaneda-Guarderas, et al. 2016].

Clinician bias has been associated with health disparities and can have profoundly negative effects [FitzGerald and Hurst 2017; Hall, et al. 2015]. It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use [Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012]. With its emphasis on eliciting patient information, a shared decision-making approach encourages clinicians to inquire about patients’ lived experiences rather than making assumptions and to recognize the influence of that experience in healthcare decision-making.

Stigma: Stigma may prevent individuals from seeking or receiving treatment and harm reduction services [Tsai, et al. 2019]. Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes [Turan, et al. 2017; Chambers, et al. 2015], and stigma among clinicians against people who use substances has been well-documented [Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013]. Sexual and reproductive health, including strategies to prevent HIV transmission, acquisition, and progression, may be subject to stigma, bias, social influence, and violence.

SHARED DECISION-MAKING IN HIV CARE
  • As prevention and treatment modalities in HIV care expand (i.e., vaccines, barriers, injectables, implants, on-demand therapies), it is important for clinicians to ask patients about their goals for prevention and treatment rather than assume that efficacy is the primary factor in patient preference [Sewell, et al. 2021].
  • The shared decision-making approach to clinical care enhances patient knowledge and uptake of new technologies and behavioral practices that align with the patient’s unique preferences and identity [Sewell, et al. 2021], ensures that the selection of a care plan is mutually agreed upon, and considers the patient’s ability to effectively use and adhere to the selected course of prevention or treatment.

Resources and Suggested Reading

In addition to the references cited below, the following resources and suggested reading may be useful to clinicians.

RESOURCES
References

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Stone EM, Kennedy-Hendricks A, Barry CL, et al. The role of stigma in U.S. primary care physicians’ treatment of opioid use disorder. Drug Alcohol Depend 2021;221:108627. [PMID: 33621805]

Tsai AC, Kiang MV, Barnett ML, et al. Stigma as a fundamental hindrance to the United States opioid overdose crisis response. PLoS Med 2019;16(11):e1002969. [PMID: 31770387]

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van Boekel LC, Brouwers EP, van Weeghel J, et al. Stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review. Drug Alcohol Depend 2013;131(1-2):23-35. [PMID: 23490450]

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Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication December 15, 2022
Date of current publication June 08, 2023
Highlights of changes, additions, and updates in the June 08, 2023 edition

The COVID-19 vaccination section has been updated to align with the CDC’s May 2023 recommendations.

Intended users New York State clinicians who provide primary care to adults with HIV
Lead author(s)

Christine Kerr, MD; Mary Dyer, MD

Contributing author

Marguerite A. Urban, MD

Writing group

Steven M. Fine, MD, PhD; Rona Vail, MD; Joseph P. McGowan, MD, FACP, FIDSA; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Lyn C. Stevens, MS, NP, ACRN; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH

Author and writing group conflict of interest disclosures

Joseph P. McGowan, MD, FACP, FIDSA: Institutional Pharma grant recipient/support, clinical trial; Gilead

Committee

Medical Care Criteria Committee

Developer and funder

New York State Department of Health AIDS Institute (NYSDOH AI)

Development process

See Guideline Development and Recommendation Ratings Scheme, below.

Related NYSDOH AI guidelines

Guideline Development and Recommendation Ratings

Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program
Program manager Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff.
Mission To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered.
Expert committees The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout New York State to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of New York State, all relevant clinical practice settings, key New York State agencies, and community service organizations.
Committee structure
  • Leadership: AI-appointed chair, vice chair(s), chair emeritus, clinical specialist(s), JHU Guidelines Program Director, AI Medical Director, AI Clinical Consultant, AVAC community advisor
  • Contributing members
  • Guideline writing groups: Lead author, coauthors if applicable, and all committee leaders
Disclosure and management of conflicts of interest
  • Annual disclosure of financial relationships with commercial entities for the 12 months prior and upcoming is required of all individuals who work with the guidelines program, and includes disclosure for partners or spouses and primary professional affiliation.
  • The NYSDOH AI assesses all reported financial relationships to determine the potential for undue influence on guideline recommendations and, when indicated, denies participation in the program or formulates a plan to manage potential conflicts. Disclosures are listed for each committee member.
Evidence collection and review
  • Literature search and review strategy is defined by the guideline lead author based on the defined scope of a new guideline or update.
  • A comprehensive literature search and review is conducted for a new guideline or an extensive update using PubMed, other pertinent databases of peer-reviewed literature, and relevant conference abstracts to establish the evidence base for guideline recommendations.
  • A targeted search and review to identify recently published evidence is conducted for guidelines published within the previous 3 years.
  • Title, abstract, and article reviews are performed by the lead author. The JHU editorial team collates evidence and creates and maintains an evidence table for each guideline.
Recommendation development
  • The lead author drafts recommendations to address the defined scope of the guideline based on available published data.
  • Writing group members review the draft recommendations and evidence and deliberate to revise, refine, and reach consensus on all recommendations.
  • When published data are not available, support for a recommendation may be based on the committee’s expert opinion.
  • The writing group assigns a 2-part rating to each recommendation to indicate the strength of the recommendation and quality of the supporting evidence. The group reviews the evidence, deliberates, and may revise recommendations when required to reach consensus.
Review and approval process
  • Following writing group approval, draft guidelines are reviewed by all contributors, program liaisons, and a volunteer reviewer from the AI Community Advisory Committee.
  • Recommendations must be approved by two-thirds of the full committee. If necessary to achieve consensus, the full committee is invited to deliberate, review the evidence, and revise recommendations.
  • Final approval by the committee chair and the NYSDOH AI Medical Director is required for publication.
External reviews
  • External review of each guideline is invited at the developer’s discretion.
  • External reviewers recognized for their experience and expertise review guidelines for accuracy, balance, clarity, and practicality and provide feedback.
Update process
  • JHU editorial staff ensure that each guideline is reviewed and determined to be current upon the 3-year anniversary of publication; guidelines that provide clinical recommendations in rapidly changing areas of practice may be reviewed annually. Published literature is surveilled to identify new evidence that may prompt changes to existing recommendations or development of new recommendations.
  • If changes in the standard of care, newly published studies, new drug approval, new drug-related warning, or a public health emergency indicate the need for immediate change to published guidelines, committee leadership will make recommendations and immediate updates and will invite full committee review as indicated.
Recommendation Ratings Scheme
Strength Quality of Evidence
Rating Definition Rating Definition
A Strong 1 Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints.
B Moderate * Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.
C Optional 2 Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes.
2† Extrapolated from published results of well-designed studies (including nonrandomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline.
3 Based on committee expert opinion, with rationale provided in the guideline text.

Last updated on February 7, 2024