Immunizations for Adults With HIV

Date of current publication: April 2, 2024
Lead authors: Christine Kerr, MD; Mary Dyer, MD
Contributor: Marguerite A. Urban, MD
Writing group: Rona M. Vail, MD, AAHIVS; Sanjiv S. Shah, MD, MPH, AAHIVM, AAHIVS; Steven M. Fine, MD, PhD; Joseph P. McGowan, MD, FACP, FIDSA, AAHIVS; Samuel T. Merrick, MD, FIDSA; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Jessica Rodrigues, MPH, MS; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD
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.

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. 2021; Crum-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 2022; Thompson, 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 1996; Redfield, et al. 1987; CDC 1985; Davis, 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.

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. 2002; Rey, 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. 2021; Sullivan, 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. 2021; Grohskopf, et al. 2019; Fiore, 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. 2021; Fiore, et al. 2011; Cortese and Parashar 2009; Marin, 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.

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:

• CDC: COVID-19: Understanding Risk
• NYC Health: COVID-19: Prevention and Groups at Higher Risk > People at Increased Risk of Severe Illness
• U.S. Department of Health and Human Services: Guidance for COVID-19 and People With HIV
• National Institutes of Health: COVID-19 Treatment Guidelines: Special Considerations in People With HIV

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; Patel, et al. 2021; Tesoriero, et al. 2021; Cooper, et al. 2020; Nandy, et al. 2020; Ssentongo, 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. 2021; Patel, et al. 2021; Ssentongo, et al. 2021; Byrd, 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. 2023; Chambers, 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.

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 2023; Thompson, et al. 2021; Briere, 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. 2016; Dockrell, et al. 1999; Kroon, et al. 1997; Steinhoff, et al. 1991.

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

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

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. 2015; Mast, et al. 2006, with diminishing response with lower CD4 cell counts Pollack, et al. 2016; Pettit, et al. 2010; Kim, et al. 2008; Overton, et al. 2005. Undetectable or very low viral load is associated with increased response to HBV vaccination Mena, et al. 2015; Kim, et al. 2008; Overton, 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 2022; Whitaker, 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. 2013; Launay, 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. 2012; Fonseca, 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 2022; Thompson, 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. 2010; Cooper, et al. 2005; Sasaki, 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. 2010; Cardell, et al. 2008; de 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.

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. 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(a) 2021.

Discussion: People with HIV are at greater risk of severe morbidity from an influenza infection Grohskopf, et al. 2019; Kunisaki 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. 2021; Grohskopf, et al. 2019. Inactivated influenza vaccine offers protective immunity in adults with HIV Grohskopf, et al. 2019; Remschmidt, et al. 2014; Beck, 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. 2016; Crum-Cianflone(a), et al. 2011; Evison, et al. 2009; Yamanaka, et al. 2005; Kroon, 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. 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 ≥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. 2013; Cooper, 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. 2016; Werker, 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.

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. 2012; Aurpibul, 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. 1998; CDC 1996. Serious adverse effects have not been reported in adults who were not severely immunocompromised Chaiwarith, et al. 2016; McLean, et al. 2013; Belaunzaran-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.

Discussion: Adults with HIV are at increased risk of invasive meningococcal disease due to serogroups C, W, and Y Mbaeyi, et al. 2020; Folaranmi, 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. 2012; Siberry, 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.

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.

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.

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

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 2023; Kobayashi, 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 2023; Kobayashi, 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. 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/mm³ who 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.

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

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 2023; Marin, et al. 2007; Kramer, 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 2014; CDC 2012; Marin, 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 2022; Marin, 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 2022; Marin, 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 2022; CDC(b) 2021. If post-exposure varicella zoster immune globulin is given, clinicians should wait ≥5 months before varicella vaccination ACIP 2022; DHHS 2022; CDC 2006.

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. 2012; Harpaz, 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. 2022; Dooling, 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.

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

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.

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]

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].

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.

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

References

Acree ME, McNulty M, Blocker O, et al. Shared decision-making around anal cancer screening among black bisexual and gay men in the USA. Cult Health Sex 2020;22(2):201-16. [PMID: 30931831]

Avery JD, Taylor KE, Kast KA, et al. Attitudes toward individuals with mental illness and substance use disorders among resident physicians. Prim Care Companion CNS Disord 2019;21(1):18m02382. [PMID: 30620451]

Bertakis KD, Azari R. Patient-centered care is associated with decreased health care utilization. J Am Board Fam Med 2011;24(3):229-39. [PMID: 21551394]

Castaneda-Guarderas A, Glassberg J, Grudzen CR, et al. Shared decision making with vulnerable populations in the emergency department. Acad Emerg Med 2016;23(12):1410-16. [PMID: 27860022]

Chambers LA, Rueda S, Baker DN, et al. Stigma, HIV and health: a qualitative synthesis. BMC Public Health 2015;15:848. [PMID: 26334626]

Chen CH, Kang YN, Chiu PY, et al. Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: a randomized controlled trial. Patient Educ Couns 2021;104(10):2498-2504. [PMID: 33741234]

Coronado-Vázquez V, Canet-Fajas C, Delgado-Marroquín MT, et al. Interventions to facilitate shared decision-making using decision aids with patients in primary health care: a systematic review. Medicine (Baltimore) 2020;99(32):e21389. [PMID: 32769870]

Coulter A, Collins A. Making shared decision-making a reality: no decision about me, without me. 2011. https://www.kingsfund.org.uk/sites/default/files/Making-shared-decision-making-a-reality-paper-Angela-Coulter-Alf-Collins-July-2011_0.pdf

Crawford J, Petrie K, Harvey SB. Shared decision-making and the implementation of treatment recommendations for depression. Patient Educ Couns 2021;104(8):2119-21. [PMID: 33563500]

FitzGerald C, Hurst S. Implicit bias in healthcare professionals: a systematic review. BMC Med Ethics 2017;18(1):19. [PMID: 28249596]

Greenwood BN, Hardeman RR, Huang L, et al. Physician-patient racial concordance and disparities in birthing mortality for newborns. Proc Natl Acad Sci U S A 2020;117(35):21194-21200. [PMID: 32817561]

Groot G, Waldron T, Barreno L, et al. Trust and world view in shared decision making with indigenous patients: a realist synthesis. J Eval Clin Pract 2020;26(2):503-14. [PMID: 31750600]

Hall WJ, Chapman MV, Lee KM, et al. Implicit racial/ethnic bias among health care professionals and its influence on health care outcomes: a systematic review. Am J Public Health 2015;105(12):e60-76. [PMID: 26469668]

Halperin B, Melnychuk R, Downie J, et al. When is it permissible to dismiss a family who refuses vaccines? Legal, ethical and public health perspectives. Paediatr Child Health 2007;12(10):843-45. [PMID: 19043497]

Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. 2001. https://www.ncbi.nlm.nih.gov/books/NBK222274/

KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. https://www.kff.org/racial-equity-and-health-policy/report/key-data-on-health-and-health-care-by-race-and-ethnicity/ [accessed 2023 May 19]

Livingston JD, Milne T, Fang ML, et al. The effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review. Addiction 2012;107(1):39-50. [PMID: 21815959]

McNulty MC, Acree ME, Kerman J, et al. Shared decision making for HIV pre-exposure prophylaxis (PrEP) with black transgender women. Cult Health Sex 2022;24(8):1033-46. [PMID: 33983866]

Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, et al. Shared decision making in surgery: a meta-analysis of existing literature. Patient 2020;13(6):667-81. [PMID: 32880820]

Parish SJ, Hahn SR, Goldstein SW, et al. The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women. Mayo Clin Proc 2019;94(5):842-56. [PMID: 30954288]

Robinson JH, Callister LC, Berry JA, et al. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract 2008;20(12):600-607. [PMID: 19120591]

Scalia P, Durand MA, Elwyn G. Shared decision-making interventions: an overview and a meta-analysis of their impact on vaccine uptake. J Intern Med 2022;291(4):408-25. [PMID: 34700363]

Sewell WC, Solleveld P, Seidman D, et al. Patient-led decision-making for HIV preexposure prophylaxis. Curr HIV/AIDS Rep 2021;18(1):48-56. [PMID: 33417201]

Stalnikowicz R, Brezis M. Meaningful shared decision-making: complex process demanding cognitive and emotional skills. J Eval Clin Pract 2020;26(2):431-38. [PMID: 31989727]

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]

Turan B, Budhwani H, Fazeli PL, et al. How does stigma affect people living with HIV? The mediating roles of internalized and anticipated HIV stigma in the effects of perceived community stigma on health and psychosocial outcomes. AIDS Behav 2017;21(1):283-91. [PMID: 27272742]

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]