Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV

Overview

The Advisory Committee on Immunization Practices (ACIP) recommends immunizing people with HIV similarly to the general population, with a few key exceptions.

• The following live virus vaccines are contraindicated in people with HIV:
  • For CD4 T lymphocyte (CD4) cell count <200 cells/mm³:
    • Measles
    • Mumps
    • Rubella
    • Varicella (VAR)
    • Live attenuated typhoid Ty21a
    • Yellow fever
  • For any CD4 counts:
    • Live attenuated influenza vaccine (LAIV)
    • Live attenuated smallpox vaccine (ACAM2000)
  • The following vaccines have specific recommendations related to HIV status:
    • COVID-19
    • Hepatitis A (HepA)
    • Hepatitis B (HepB)
    • Meningococcus serogroup A, C, W, Y (MenACWY)
    • Pneumococcal vaccines
    • Human papillomavirus

The National Institutes of Health/Infectious Diseases Society of America/HIV Medicine Association recommendations described here may differ from ACIP recommendations when the committees interpret data differently or when one guideline has been updated more recently than the other. Please see the Recommended Adult Immunization Schedule by Medical Condition and Other Indications table, Recommended Immunizations for Travel table, and Recommended Immunization Schedule for Adults and Adolescents With HIV figure at the end of this chapter for a full overview of vaccines for adults with HIV, including standard vaccines recommended for all individuals.

Specific Immunizations

COVID-19 Vaccine

Available Vaccines

• Adjuvanted protein subunit vaccine
  • Nuvaxovid (Novavax)
• mRNA vaccine
  • mNEXSPIKE (Moderna)
  • Spikevax (Moderna)
  • Comirnaty (Pfizer-BioNTech)

Summary of Recommendations

• For adolescents and adults with HIV, administer a dose of the current season COVID-19 vaccine regardless of their CD4 count, HIV viral load, or pregnancy or breastfeeding status (AII).
• Individuals with advanced or untreated HIV are considered moderately or severely immunocompromised and may receive one additional dose 6 months after their last COVID-‍19 vaccine dose (AIII).
  • Note: Advanced HIV is defined as CD4 count <200 cells/mm³, a history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV.
  • The second dose to extend protection throughout the year may be considered given the frequent peaks in circulation outside the winter months. Future guidance may be needed to reflect changes in the seasonality of the virus.
• For never vaccinated and incompletely vaccinated people, refer to published vaccine-specific guidelines.¹

Evidence Summary

People with HIV and COVID-19 have experienced worse outcomes and greater mortality than people without HIV in studies from the United States, the United Kingdom, and South Africa.^2-9 HIV was independently associated with an increased risk of severe and critical COVID-19 in a large trial from the World Health Organization’s Global Clinical Platform, which included data from 38 countries.¹⁰ In a multicenter cohort study of 286 people with HIV and COVID-19 in the United States, a lower CD4 count (i.e., <200 cells/mm³) was associated with a higher risk for the composite endpoint of intensive care unit admission, invasive mechanical ventilation, or death, even in those with viral suppression.⁷ Similarly, a multisite clinical cohort of people with HIV in clinical care in the United States showed an association between lower current (<350 cells/mm³) and nadir (<200 cells/mm³) CD4 counts and risk of hospitalization, intubation, or death, regardless of viral suppression status.¹¹

Most people with HIV develop antibody responses to vaccination comparable to responses measured in people without HIV.^12-17 However, responses may be lower and antibody titers decline faster, particularly for individuals^14-16 with CD4 counts <200 cells/mm³. Rates of breakthrough infections after vaccination are higher among individuals with HIV, with vaccine effectiveness declining sooner than in HIV-negative matched cohorts.^18-20 Breakthrough infections showed no association with viral load suppression, though fewer breakthroughs¹⁸ were seen in individuals with CD4 counts ≥500 cells/mm³. Vaccine effectiveness against more severe outcomes (e.g., hospitalization, intensive care unit admission, death) has been more robust than protection against infection or mild disease.²¹

For individuals with advanced or untreated HIV, the lower seroresponse rates and reduced vaccine effectiveness compared with individuals without immunocompromise support recommendations for additional doses to extend protection through the year because there are often peaks in circulation outside the winter season.²²

Four COVID-19 vaccines are available in the United States: three mRNA formulations (mNEXSPIKE and Spikevax from Moderna and Comirnaty from Pfizer-BioNTech) and one adjuvanted recombinant protein (Nuvaxovid from Novavax). Since 2023, the original vaccines are no longer authorized and have been replaced with updated versions that better match circulating variants. Primary and booster vaccines have been harmonized to a single strain, and annual assessments are anticipated to update vaccine composition and scheduling recommendations.²³

All adults and adolescents, regardless of their CD4 count or HIV viral load, should receive a dose of the newest updated COVID-19 vaccine when available (at least 4–8 weeks after last dose).^22,24 Those with severe immunosuppression may have a diminished immune response to the vaccine and therefore may receive one additional dose 6 months after the last COVID-19 vaccine dose.

Hepatitis A Vaccine

See the “Hepatitis A virus (HAV)” section in the table below for detailed guidance on immunization against HAV.

Available Vaccines

• Single-antigen inactivated hepatitis A vaccines
  • HepA (Havrix, GSK)
  • HepA (Vaqta, Merck)
• Combination inactivated hepatitis A vaccine and recombinant hepatitis B vaccine
  • HepA-HepB (Twinrix, GSK)

Summary of Recommendations

For Vaccination

• For people who are not immune to HAV (IgG negative), administer a two-dose series of single-antigen hepatitis A vaccine (HepA). The dosing interval depends on the vaccine used: at 0 and 6–‍12 months for Havrix (AII) or 0 and 6–18 months for Vaqta (AIII).
• For those who are not immune to HAV and hepatitis B virus (HBV), administer a two-dose series of HepA vaccine and two doses of HepBCpG (Heplisav-B) (AII). Alternatively, if HepBCpG is not available, a three-dose series (0, 1, and 6 months) of the combined hepatitis A and hepatitis B vaccine (HepA-HepB, Twinrix) may be administered (AII).
• For travelers, some clinicians recommend a four-dose accelerated regimen (0, 7, 21–‍30 days, and 12 months) of HepA-HepB (BII).
• For people with HIV and CD4 count ≥200 cells/mm³, assess antibody response 1 to 2 months after completion of the series. If negative, a third dose may be administered (BIII).
• People with HIV with CD4 count <200 cells/mm³ who have ongoing risk for HAV infection should be immunized at entry to care and assessed for antibody response 1 to 2 months after completion of the series. If negative, revaccinate when their CD4 count is >200 cells/mm³ (BIII).
• For people with HIV with CD4 count <200 cells/mm³ who do not have ongoing risk for HAV infection, waiting for a CD4 count >200 cells/mm³ prior to immunization is an option (BIII).
• One study showed lower seroresponse to HepA when coadministered with pneumococcal conjugate vaccine. For patients who need both, clinicians may choose to separate by 1 month (CIII).²⁵

For Pre-exposure Prophylaxis (Travel)

• For people with HIV who are nonimmune and traveling within 2 weeks to countries with endemic HAV, consider administering immunoglobulin G (IgG) 0.1 mL/kg if duration of travel is <1 month. If duration of travel is 1 to 2 months, administer IgG 0.2 mL/kg. If duration of travel is ≥2 months, IgG 0.2 mL/kg should be repeated every 2 months. 

For Post-exposure Prophylaxis

• For people with HIV who are nonimmune, administer HepA and IgG 0.1 mL/kg simultaneously in different anatomical sites as soon as possible, within 2 weeks of exposure. Complete the HepA series following the dosing intervals for the selected vaccine. 

Hepatitis B Vaccine

See the “Preventing Disease” section in Hepatitis B Virus Infection for detailed guidance on immunization against HBV, as well as the evidence summary.

Available Vaccines

• Recombinant hepatitis B vaccine, CpG-adjuvanted
  • HepBCpG (Heplisav-B, Dynavax)
• Recombinant hepatitis B vaccines (conventional monovalent)
  • HepB (Engerix-B, GSK)
  • HepB (Recombivax HB, Merck)
• Combination inactivated hepatitis A and recombinant hepatitis B recombinant vaccine
  • HepA-HepB (Twinrix, GSK)

Summary of Recommendations

For Vaccination

• Indications for hepatitis B vaccination
  • People without chronic HBV infection and without immunity to HBV (negative for hepatitis B surface antigen, hepatitis B core antibody [anti-HBc], and hepatitis B surface antibody [anti-HBs]) (AII).
  • Although vaccine response is better in people with CD4 count >350 cells/mm³, vaccination should not be deferred in people with a lower CD4 count who are at increased risk of HBV infection, because some people with CD4 <350 cells/mm³ do respond to vaccination (AII).
• Preferred
  • Heplisav-B intramuscularly (IM) at 0 and 4 weeks (AII)
• Alternative (if HepBCpG [Heplisav-B] is unavailable)
  • Engerix-B 40 mcg (two simultaneous injections of 20 mcg each) at 0, 1, and 6 months (these doses are considered a “double-dose,” three-dose series) (AII); or
  • Recombivax HB 20 mcg (two injections of 10 mcg each) at 0, 1, and 6 months (these doses are considered a “double-dose,” three-dose series) (AII); or
  • Twinrix combined HepA and HepB vaccine (1 mL IM) as a three-dose series (at 0, 1, and 6 months) (AII)
• Vaccination schedule for prior non-responders (anti-HBs <10 mIU/ml) 1 month after complete vaccine series
  • If prior Engerix-B or Recombivax HB vaccination failed, administer HepBCpG (Heplisav-B) IM at 0 and 4 weeks (AI), with consideration for a third dose of HepBCpG at 24 weeks (BIII).
  • If prior two-dose HepBCpG (Heplisav-B) vaccination failed, administer a third dose of HepBCpG (Heplisav-B) IM at 24 weeks after first dose (AII).
• Assess for vaccine response
  • Anti-HBs should be obtained 4 weeks after completion of the vaccine series to document response to vaccination, defined as anti-HBs ≥10 mIU/ml (AII).
• Vaccination schedule for people with isolated anti-HBc
  • One dose of any hepatitis B vaccine followed by testing for quantitative anti-HBs 1 to 2 months post-dose
    • If the titer is >100 mIU/mL, no further vaccination is needed.*
    • If the titer is ≤100 mIU/mL, a complete series of hepatitis B vaccine should be completed (see above for Vaccination Schedule), followed by repeat anti-HBs testing (BII).
    • If an anti-HBs quantitative titer is not available, then a complete hepatitis B vaccine series is recommended, followed by qualitative anti-HBs testing (BII).

* See text in Hepatitis B Virus Infection regarding rationale for >100 mIU/mL.

For Post-exposure Prophylaxis

• For people who have been exposed and were vaccinated previously with a complete HepB series and have documented antibody response, no additional vaccine is needed.
• For people who have been exposed and who received a complete HepB series without documentation of antibody response, administer a single dose of HepB.
• For people who have been exposed and have not received any HepB or have not received a complete HepB series, administer or complete a HepB series and administer one dose of hepatitis B immune globulin at a separate anatomical site as soon as possible after exposure (ideally within 24 hours, but up to 7 days after percutaneous exposure and up to 14 days after sexual exposure).
   

Human Papillomavirus Vaccine

See the “HPV Vaccine” section in Human Papillomavirus Disease for detailed guidance on immunization against human papillomavirus (HPV), as well as the evidence summary.

Available Vaccine

• 9-valent inactivated recombinant vaccine (Gardasil 9, Merck)

Summary of Recommendations

• Routine HPV vaccination is recommended for people with HIV. Ideally, the series should be initiated at age 11 or 12 years but may be started as early as age 9 years. For all people with HIV who are aged 13 to 26 years and who were not vaccinated previously, regardless of sex, administer three doses of the recombinant HPV 9-valent vaccine (Gardasil 9) at 0, 1 to 2, and 6 months (AIII). The two-dose series is not recommended for people with HIV.
• Shared clinical decision-making regarding HPV vaccination is recommended for people with HIV who are aged 27 to 45 years and who were not adequately vaccinated previously (AIII).
• At present, vaccination with commercially available HPV vaccine is not recommended during pregnancy (CIII). However, in post-hoc analyses of clinical trials and population-based studies, HPV vaccines have not been linked to adverse pregnancy outcomes.^26-29
• For people who have completed a vaccination series with the recombinant HPV bivalent or quadrivalent vaccine, some experts would consider additional vaccination with recombinant HPV 9-valent vaccine, but data are lacking to define the efficacy and cost-effectiveness of this approach (CIII).

Influenza Vaccine

Available Vaccines*

• Inactivated Influenza vaccine (IIV3) (standard-dose, egg-based vaccine)
  • Afluria (Seqirus)
  • Fluarix (GSK)
  • FluLaval (GSK)
  • Fluzone (Sanofi Pasteur)
• ccIIV3 (standard dose, cell culture-based vaccine)
  • Flucelvax (Seqirus)
• HD-IIV3 (high-dose, egg-based vaccine)
  • Fluzone High-Dose (Sanofi Pasteur)
• aIIV3 (standard-dose, egg-based vaccine with MF59 adjuvant)
  • Fluad (Seqirus)
• RIV3 (recombinant hemagglutinin [HA] vaccine)
  • Flublok (Sanofi Pasteur)
• LAIV3 (live attenuated, egg-based vaccine)
  • FluMist (AstraZeneca)

* Vaccine formulations are updated yearly to reflect circulating strains.

Summary of Recommendations

• For all adults and adolescents with HIV, administer age-appropriate inactivated influenza vaccine or recombinant influenza vaccine annually (AI).
• For pregnant women with HIV, administer inactivated influenza or recombinant vaccine at any time during pregnancy (AI).
• LAIV administered via nasal spray is contraindicated in people with HIV (AIII).
• High-dose, recombinant, and adjuvanted influenza vaccines are recommended for people with HIV aged 65 years or older over standard-dose unadjuvanted inactivated vaccines (AII).³⁰

Evidence Summary

Influenza is a common respiratory disease in adults and adolescents. Annual epidemics of seasonal influenza typically occur in the United States between October and April. Influenza A and B are most frequently implicated in human epidemics. Influenza A viruses are categorized into subtypes based on characterization of two surface antigens: hemagglutinin and neuraminidase. Although vaccine-induced immunity to these surface antigens reduces the likelihood of infection,^31,32 the frequent emergence of antigenic variants through antigenic drift³³ (i.e., point mutations and recombination events within a subtype) is the virologic basis for seasonal epidemics and necessitates revaccination each season.³⁴

Some studies of influenza have noted higher hospitalization rates^35-38 and increased mortality^38,39 among people with HIV; however, these findings have not been observed in all settings.⁴⁰ Increased morbidity may be greatest for people with HIV not receiving effective antiretroviral therapy (ART) or with advanced disease. People with HIV are at high risk of serious influenza-related complications.

In general, people with HIV with minimal AIDS-related symptoms and normal or near-normal CD4 counts who receive inactivated influenza vaccine (IIV) develop adequate antibody responses.^41-43 Among people with a low CD4 count or who have advanced HIV disease, IIV might not induce protective antibody titers.^43-45 In one study, markers of inflammation in older people (≥60 years) with HIV were associated with lower post-vaccination influenza antibody titers.⁴⁶ In people with HIV, a second dose of vaccine does not improve immune response,^44,47 and intradermal influenza vaccine dosing did not improve the immune response compared with intramuscular dosing.⁴⁸

Influenza vaccines are trivalent (two A components and one B component) in the 2025–2026 season, with formulations and number of components that can change from season to season. Two clinical studies have evaluated influenza vaccine efficacy in people with HIV. In an investigation of an influenza A outbreak at a residential facility for people with HIV,³⁵ vaccination was most effective at preventing influenza-like illness among people with a CD4 count >100 cells/mm³ and among those with HIV RNA <30,000 copies/mL. In a randomized placebo-controlled trial conducted in South Africa among 506 people with HIV, including 349 people on ART and 157 who were ART naive, efficacy of trivalent IIV for prevention of culture- or reverse transcription–polymerase chain reaction–confirmed influenza illness was 75% (95% confidence interval, 9% to 96%).⁴⁹

Several clinical studies also have evaluated the immunogenicity of influenza vaccine in people with HIV. In a randomized study⁵⁰ comparing the immunogenicity of high-dose (60 mcg of antigen per strain) versus standard-dose (15 mcg of antigen per strain) trivalent IIV among 195 adults with HIV aged ≥18 years (10% of whom had a CD4 count <200 cells/mm³), seroprotection rates were higher in the high-dose group for influenza A (96% vs. 87%; P = 0.029) and influenza B (91% vs. 80%; P = 0.030). However, in a comparative study of 41 children and young adults with HIV, high-dose trivalent IIV was no more immunogenic than the standard dose among the recipients with HIV.⁵¹

Although booster doses can make the influenza vaccine more effective, that benefit is limited to specific groups, such as solid-organ transplant recipients.⁵² One study in people with HIV assessed the effectiveness of a two-dose regimen of IIV and found that the second dose of vaccine did not significantly increase the frequency or magnitude of antibody responses.⁴⁷ Based on this study, influenza booster immunizations are not recommended for people with HIV.

Optimally, influenza vaccination should occur before onset of influenza activity in the community because it takes about 2 weeks after vaccination for protective antibodies to develop.³⁰ Health care providers should offer vaccination by the end of October if possible, and vaccination should continue to be offered as long as influenza viruses are circulating. Information on currently available influenza vaccines is obtainable through the Centers for Disease Control and Prevention’s (CDC) recommendations on the 2025–2026 influenza season. For adults aged ≥65 years, high-dose IIV,⁵³ adjuvanted IIV,⁵⁴ or recombinant influenza vaccine⁵⁵ are preferentially recommended over standard-dose unadjuvanted vaccines based on data suggesting higher efficacy in preventing invasive pneumococcal disease (IPD) in this age group.⁵⁶

Although a LAIV is available, it is contraindicated for people with HIV because of the paucity of safety data and the availability of alternative vaccines.⁵⁷ Although unintentional administration of LAIV to adults with HIV has been well tolerated,⁵⁸ it is not recommended for people with HIV.

IIVs can be administered to people receiving influenza antiviral drugs for treatment or chemoprophylaxis. Concurrent administration of influenza vaccine does not interfere with the immune response to other inactivated vaccines or to live vaccines.

Measles, Mumps, and Rubella Vaccine

Available Vaccines

• Live attenuated measles, mumps, and rubella (MMR) combination vaccine
  • M-M-R II (Merck)
  • Priorix (GSK)

Summary of Recommendations

For Vaccination

• Administer two doses of MMR vaccine at least 1 month apart to people with a CD4 count ≥200 cells/mm³ and who have no evidence of immunity to MMR (evidence of immunity is defined as: patient was born before 1957 or has documentation of receipt of MMR vaccine or has laboratory evidence of immunity or disease) (AIII).
• The MMR vaccine is not recommended during pregnancy (AII).
• Women of childbearing potential who get the MMR vaccine should wait 4 weeks before getting pregnant.
• For pregnant women without immunity to rubella, delay immunization until after pregnancy and then administer two doses of the MMR vaccine at least 1 month apart if the CD4 count is ≥200 cells/mm³ and on combination ART (AIII).
• If no serologic evidence of immunity exists after two doses of MMR vaccine, consider repeating the two-dose MMR vaccine series, especially if the person is vaccinated while not virologically suppressed (CIII).
• Do not administer MMR vaccine to people with HIV with CD4 count <200 cells/mm³ or uncontrolled HIV (not on ART or virologic failure) (AIII).

For Post-exposure Prophylaxis

• For measles exposure of nonimmune individuals with CD4 count ≥200 cells/mm³, administer either MMR vaccine within 72 hours of exposure or immunoglobulin (IG) within 6 days of exposure. Do not administer the MMR vaccine and IG simultaneously.
• For measles exposure of nonimmune individuals with CD4 count <200 cells/mm³ or who are pregnant, administer IG within 6 days of exposure.

Evidence Summary

Measles is a highly contagious and potentially life-threatening disease. Measles is particularly virulent in the immunocompromised host, with a reported mortality rate as high as 40% in people with advanced HIV.⁵⁹ Worldwide, the incidence of measles has continued to rise, with several ongoing outbreaks, and the United States has experienced a resurgence of measles. The CDC reported 2,267 measles in 2025, up from 285 cases in 2024 and 59 cases in 2023. Almost 90% of cases were associated with outbreaks, and this increase is largely attributable to decreased rates of vaccination. Current information regarding outbreaks can be found on the CDC website Measles Cases and Outbreaks.⁶⁰

A study from a large urban HIV clinic in the U.S. reported that measles immune status is rarely documented (11.2%) in patient medical records.^61,62 With a resurgence of measles both domestically⁶³ and globally,⁶⁴ all people with HIV should be assessed for immunity or prior vaccination and vaccinated if MMR vaccine is indicated. Acceptable evidence of immunity includes being born before 1957, documented evidence of two doses of the MMR vaccine, or presence of positive antibody titers and this information should be documented.

Several studies from the 1990s found that 90% to 95% of adults with HIV were immune to measles.^65-67 but in a 2020 study, the measles seroprevalence rate was only 70.3%.⁶⁸ In these studies, serostatus did not vary by CD4 count, suggesting that people with HIV retained protective immunity even in the context of advanced disease. Similarly, people with HIV appear to retain immunity to mumps and rubella even after acquisition of HIV.⁶⁹

Individuals who do not fulfill any criteria for immunity and have CD4 counts ≥200 cells/mm³ should receive two doses of MMR vaccine separated by at least 28 days. The combination measles, mumps, rubella, and varicella (MMRV) vaccine has not been studied in immunocompromised hosts and should not be administered to people with HIV (AIII).

The MMR vaccine is contraindicated for people with HIV with CD4 counts <200 cells/mm³ because the MMR vaccine is a live attenuated formulation that has been linked to fatal cases of measles‑associated pneumonitis following administration to people with HIV with a low CD4 count (AIII).^70,71 For people with HIV with CD4 count ≥200 cells/mm³, the vaccine has been shown to be safe, although antibody response may be lower than for patients without HIV.^69,72,73 The MMR vaccine is also contraindicated for people with other immunocompromised conditions.

For more detailed information regarding post-exposure prophylaxis, please see the CDC webpage Measles (Rubeola).

Meningococcal Vaccine

Available Vaccines

• Quadrivalent meningococcal conjugate vaccine (MenACWY)
  • Menveo (GSK)
  • MenQuadfi (Sanofi Pasteur)
• Recombinant meningococcal group B vaccine (MenB)
  • Bexsero (GSK)
  • Trumenba (Pfizer)
• Pentavalent meningococcal vaccine (MenABCWY; combines conjugated MenACWY with recombinant MenB)
  • Penbraya (Pfizer)
  • Penmenvy (GSK)

Summary of Recommendations

• Administer two doses of quadrivalent meningococcal conjugate vaccine (MenACWY) at least 8 weeks apart to adolescents and adults with HIV who have not been vaccinated previously (AII).
• For people with HIV who have been vaccinated previously, repeat vaccination every 5 years throughout life (BIII).
• Serogroup B meningococcal vaccination (MenB) is not routinely indicated for all people with HIV unless they have additional risks for meningococcal disease (e.g., complement component deficiency, asplenia, or receipt of a complement inhibitor) or are at risk during a serogroup B outbreak.
• Adolescents and young adults with HIV (age 16–23 years) can be offered MenB vaccination with shared decision-making (CIII).⁷⁴
• Adults may receive a single dose of pentavalent meningococcal conjugate vaccine (MenABCWY) as an alternative to separate administration of MenACWY and MenB when both vaccines would be given on the same clinic day (BIII).

Evidence Summary

Meningococcal meningitis, caused by Neisseria meningitidis, is a leading cause of bacterial meningitis among children and young adults in the United States.⁷⁵ In the 6 years prior to the introduction of MenACWY (2000–2005), the mean annual incidence of serogroups C, W, and Y meningococcal disease among adolescents aged 11 to 15 years was 0.36 cases per 100,000 population, and it decreased to 0.01 cases per 100,000 population in the 6 years following implementation of the two-dose MenACWY series (2011–2017).⁷⁶ Two quadrivalent MenACWY vaccines and two pentavalent MenABCWY meningococcal vaccines are currently licensed and available in the United States. The quadrivalent vaccines include (1) meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM, Menveo) and (2) meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT, MenQuadfi). The pentavalent vaccines include (1) a combination of MenACWY-TT plus meningococcal group B recombinant FHbp antigens (MenACWY-TT plus MenB-FHbp; Penbraya) and (2) MenACWY plus meningococcal group B four component recombinant protein vaccine (MenACWY plus MenB-4C; Penmenvy). Meningococcal groups ACWY polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D, Menactra) is no longer available. A two-dose series of quadrivalent meningococcal vaccination is recommended for all adolescents, with the first dose at age 11 or 12 years and a second dose at age 16 years. Adolescents and adults with HIV who have not had this primary meningococcal vaccination series should receive two doses of MenACWY vaccine at least 8 weeks apart (AII). Repeated MenACWY boosters are recommended every 5 years, and MenACWY vaccines are interchangeable (BIII). MenACWY vaccines are licensed in the United States for one booster dose. Repeated boosters every 5 years is an off-label use but endorsed by ACIP.⁷⁷

A growing body of evidence supports an increased risk of meningococcal disease in people with HIV. Studies have shown a fivefold to 24-fold increased risk of meningococcal disease in people with HIV compared with people without HIV^78-80; low CD4 count and high HIV viral load are associated with increased risk.^81,82Most meningococcal infections among people with HIV in the United States have been caused by serogroups C, W, or Y.⁸²In addition, a cohort study found that uptake of the MenACWY vaccine among people with a new diagnosis of HIV infection was low, and time to receipt of first vaccination was long.⁸³

The safety and immunogenicity of MenACWY-D vaccine have been evaluated only in people with HIV who are aged 11 to 24 years. Patients with CD4 percentage ≥15% received either one or two doses (at 0 and 24 weeks) of vaccine, and those with CD4 percentage <15% received two doses (at 0 and 24 weeks). Among people with HIV who received one dose of vaccine, 21% to 63% developed an antibody titer of ≥1:128 at 72 weeks after vaccination. Antibody responses at 72 weeks in individuals with CD4 percentage <15% were less robust,⁸⁴ with only 6% to 28% achieving titers ≥1:128. Local site reactions—such as pain and tenderness at the injection site—were uncommon (3.1%), as were Grade 3 or greater events (2.2%). No vaccine-related deaths or cases of meningitis were noted. No safety or immunogenicity studies are available for quadrivalent MenACWY-CRM vaccine or the pentavalent vaccine in people with HIV, and clinical outcome data for both vaccines in people with HIV are lacking, as well.

MenB is not routinely indicated for all people with HIV unless they have additional risks for meningococcal disease. Adolescents and young adults (aged 16–23 years) with HIV can be offered MenB vaccination with shared decision-making (CIII).⁷⁴ MenB vaccine provides short-term protection against most strains of serogroup B meningococcal disease and has been used for patients at increased risk (e.g., those living in dormitories or barracks) and during outbreaks. People with functional or anatomic asplenia (including sickle cell disease), with persistent complement component deficiency, or using a complement inhibitor (e.g., eculizumab, ravulizumab) should receive MenB vaccination.⁷⁷ Two MenB vaccines are available: MenB-4C (Bexsero) and MenB-‍FHbp (Trumenba). People with HIV should receive the three-dose series for MenB, given at 0, 1–2, and 6 months, rather than the two-dose option recommended for healthy adolescents and young adults. MenB-4C consists of three recombinant proteins in addition to outer membrane vesicles that contain outer membrane protein porin A. MenB-FHbp consists of two purified recombinant lipidated FHbp antigens. MenB vaccines are not interchangeable; the same product must be used for all doses in the series. A MenB vaccine booster may be indicated if a person has ongoing high risk for serogroup B meningococcal disease. In this situation, a single dose of the same vaccine is recommended ≥1 year after the MenB primary series completion and every 2 to 3 years thereafter. A booster dose may also be recommended by public health authorities for people at increased risk of exposure during a serogroup B meningitis outbreak. 

Urban outbreaks of meningococcal meningitis (several different serogroups) have been reported in the United States among men both with and without HIV who have sex with men. Several outbreaks were associated with clubs and bathhouses. Some public health jurisdictions now recommend meningococcal vaccine for all men who have sex with men, regardless of HIV status; however, ACIP has not adopted this recommendation for men without HIV who have sex with men.⁸⁵

During pregnancy and when lactating, women with HIV should receive MenACWY vaccine if indicated (AIII). No safety signals related to maternal and neonatal adverse events (including spontaneous abortion and birth defects) with MenACWY vaccine are evident in clinical trials or post-licensure surveillance.^86-90 Because only limited data are available for MenB vaccination during pregnancy, vaccination with MenB should be deferred unless the pregnant woman is at increased risk and, after consultation with their health care provider, the benefits of vaccination are considered to outweigh the potential risks (CIII).⁷⁷

Mpox Vaccine

Available Vaccines

• Live nonreplicating smallpox and mpox vaccine
  • JYNNEOS (Bavarian Nordic)

Summary of Recommendations

For Vaccination

• Indications
  • Regardless of CD4 count, all people with HIV and no prior mpox infection should be offered mpox vaccination if they have or anticipate potential exposure to mpox, per CDC clinical considerations (BII).⁹¹
  • JYNNEOS should be provided to any other people with HIV who request vaccination (CII).
  • People who have received smallpox vaccination should receive mpox vaccination (CIII).
• Vaccine
  • Modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, sold in the United States as JYNNEOS, is the preferred vaccine before mpox exposure for people with HIV because it uses a live attenuated, nonreplicating virus (AII).
  • Administer JYNNEOS in two doses 28 days apart either 0.5 mL subcutaneously (SQ) or 0.1 mL intradermally (ID). SQ administration is preferred for people with a history of keloids and recommended for people aged <18 years.
  • In situations where the second dose was not administered during the recommended interval, administer a second dose as soon as possible (CIII). Restarting or adding doses to the series when an extended interval between doses occurs is not necessary (CIII).
  • At this time, booster doses, including for people with prior mpox or who were vaccinated at CD4 counts <200 cells/mm³, are not recommended (CIII).
  • Administration of the smallpox vaccine (ACAM2000, a live replicating vaccinia vaccine) to people with HIV is contraindicated (AII).
  • Available human data on JYNNEOS administered to pregnant women are limited, and the risks and benefits of JYNNEOS should be discussed with the patient using shared decision-making (CIII).
  • If mpox vaccination is sought during pregnancy or while breastfeeding, administer JYNNEOS because it contains nonreplicating virus (AII).

For Post-exposure Prophylaxis

• Indications
  • Post-exposure vaccination is recommended for all unvaccinated people with HIV who experience a known or presumed exposure (BII).
  • Post-exposure vaccination is recommended as soon as possible, ideally within 4 days after exposure; however, administration 4 to 14 days after exposure may still provide some protection against mpox and should be offered (BII).
  • People who have received smallpox vaccination should still receive mpox post-exposure vaccination (CIII). 
• Vaccine
  • JYNNEOS is the preferred vaccine before mpox exposure for people with HIV because it uses a live attenuated, nonreplicating virus (AII).
  • Administer JYNNEOS in two doses 28 days apart either 0.5 mL SQ or 0.1 mL ID. SQ administration is preferred for people with a history of keloids and recommended for people aged <18 years.
  • When there is adequate supply of JYNNEOS, clinicians may preferentially administer via SQ route. Local side effects may be less severe with SQ administration than with ID administration. 

Evidence Summary

Mpox (formerly monkeypox) is a zoonotic viral disease caused by monkeypox virus (MPXV) that belongs to the Orthopoxvirus genus of the Poxviridae family, which also includes the causative agent of smallpox. Two main clades of MPXV have been described in different geographic regions of Africa; clade I (previously called Congo Basin clade) was classically associated with more severe disease and more human-to-human transmission than clade II (previously called West African clade).^92-94

Vaccination is the principal biomedical means of preventing mpox, regardless of clade. Vaccines active against clade II mpox are expected to be equally active against clade I. Indications for mpox vaccination are the same for people with and without HIV. Mpox vaccination should be offered to all people with HIV who have not had prior mpox and who have or anticipate potential exposure to mpox, regardless of CD4 count.⁹¹

People with HIV who are eligible for vaccination against mpox should receive MVA-BN vaccines (AII). These are live attenuated, nonreplicating viral vaccines, sold as JYNNEOS in the United States and as IMVANEX or IMVAMUNE elsewhere. Vaccination consists of two doses given 4 weeks (28 days) apart. The CDC’s considerations for mpox vaccination recommend either SQ or ID vaccine administration; both routes of administration have been shown to be similarly effective.⁹⁵ SQ administration of JYNNEOS is preferred for people with a history of keloids and recommended for people aged <18 years.

JYNNEOS has been demonstrated to be both safe for people with HIV and equally immunogenic compared with people without HIV.^96-98Several studies indicate that JYNNEOS is effective against mpox.^99-104 Matched case control study data indicate that vaccine effectiveness against symptomatic infection ranges from 36% to 75% after one dose to 66% to 89% after two doses.^100,103,104

However, these studies were limited to virologically suppressed people with CD4 counts ≥100 cells/mm³. Studies to date have had insufficient data to assess the effectiveness of JYNNEOS against mpox stratified by CD4 count, although one study reported high effectiveness regardless of CD4 count.¹⁰⁵ Immunogenicity among people with HIV who are not virologically suppressed or who have lower CD4 counts remains unknown.

The durability of immunity after mpox vaccination is unknown, including among people with HIV. Serological studies have shown declining antibody titers post-vaccination. However, the roles of innate and cell-mediated immunity remain unclear, and immunologic correlates of protection have not yet been established.¹⁰⁶ Breakthrough infections are rare but have been documented after vaccination.¹⁰⁷ A global case study from nine countries described 29 individuals who experienced mpox infections following completion of two appropriately spaced doses of JYNNEOS vaccine; of these individuals, eight had HIV and were virologically suppressed¹⁰⁸ with a median CD4 count of 555 cells/mm³. Data collected from May 2022 to May 2024 during the clade II outbreak in the United States observed 271 cases (<1% of people vaccinated) occurring at disparate time intervals after vaccination; this low proportion of post-vaccination infections suggests that immunity is not waning to date.¹⁰⁹ In both reports, vaccine-breakthrough cases experienced less severe illness with fewer lesions. Hence, at this time, booster doses are not recommended, including for people who were vaccinated at CD4 counts <200 cells/mm³ (CIII).

For people with a prior history of mpox infection, including people with HIV, vaccination is not recommended because mpox infection confers protective immunity (CIII).⁹¹ No clinical correlates of immunity have yet been established to guide when additional vaccination might be needed following prior mpox infection. Although the durability of immunity is unknown, reinfection with mpox remains very rare. Very limited observational data indicate that people who become reinfected in the United States (i.e., have acquired immunity due to infection) tend to have a self-limited illness with a lower burden of lesions that can be managed in outpatient settings.^110,111 At this time, people who had mpox with moderate-to-severe immune suppression (CD4 <200 cells/mm³) are also not recommended (CIII) to receive additional vaccinations after they achieve immune reconstitution on HIV treatment. 

Available human data on JYNNEOS administered during pregnancy are insufficient to determine vaccine-associated risks. Animal studies of JYNNEOS have shown no evidence of harm to the developing fetus.¹¹² The risks and benefits of JYNNEOS should be discussed with the patient using shared decision-making (CIII). If vaccination is sought during pregnancy or breastfeeding, JYNNEOS should be used because it contains nonreplicating virus (AII). Vaccination with ACAM2000, which contains a replication-competent virus, is contraindicated during pregnancy or while breastfeeding due to risk of pregnancy loss, congenital defects, and vaccinia virus infection in fetuses and newborns and the availability of an alternative nonreplicating viral vaccine (AII).¹¹³

Pneumococcal Vaccine

Available Vaccines

• Pneumococcal conjugate vaccines (PCVs)
  • PCV15 (Vaxneuvance, Merck)
  • PCV20 (Prevnar 20, Pfizer)
  • PCV21 (Capvaxive, Merck)
• Pneumococcal polysaccharide vaccine (PPSV)
  • PPSV23 (Pneumovax, Merck)

Summary of Recommendations

Our recommendations are generally consistent with ACIP.¹¹⁴ All people with HIV without a history of pneumococcal vaccination or with unknown vaccine history should be vaccinated as follows:

• Administer PCV21, PCV20, or PCV15 (AII). After PCV21 or PCV20, no additional pneumococcal vaccine is currently recommended.
  • In the expert opinion of the Community-Acquired Pneumonia Section Group of the Adult and Adolescent Opportunistic Infection Guidelines Panel, PCV21 is not recommended for adults with HIV if the prevalence of serotype 4 is over 30% in the region.¹¹⁵ As of September 2024, high levels of serotype 4 have been reported in Alaska, Colorado, the Navajo Nation, New Mexico, and Oregon. In these locations, people with HIV should receive PCV20 or, if PCV20 is not available, PCV15 (AIII). This guidance will be reviewed and updated as pneumococcal disease epidemiology evolves and data from other geographic areas become available.
• If PCV15 is used, administer a dose of PPSV23 at least 8 weeks later (AII). No additional pneumococcal vaccine doses are recommended. 
• For people with HIV who previously started or completed a pneumococcal vaccination series, there is no need to restart the series. Specific cases are as follows:
  • Adults who have received both PCV13 and PPSV23:
    • Adults who received PPSV23 before the age of 65 can be administered PCV21 or PCV20 at least 5 years after the last pneumococcal vaccine dose
    • Adults who received PPSV23 at age 65 or older do not require further doses of PPSV23. Their pneumococcal vaccination can be considered complete.
    • Shared clinical decision-making is recommended regarding administration of PCV21 or PCV20 for immunocompromised persons aged ≥65 years who completed their vaccine series with both PCV13 and PPSV23. If a decision to administer PCV21 or PCV20 is made, it should be given at least 5 years after the last pneumococcal vaccine dose (CIII).
  • Adults who previously received only PCV13 may receive one dose of PCV21 or PCV20 at least 1 year later (BIII)
  • Adults who have only received PPSV23 may receive PCV21 or PCV20 (or PCV15 if the former are not available) at least 1 year after their last PPSV23 dose to complete their pneumococcal vaccination series (BIII).

Evidence Summary

Some observational studies have reported benefits of PPSV against invasive pneumococcal disease (IPD)^116,117 (e.g., bacteremia, meningitis) and all-cause pneumonia^118-120 in people with HIV; however, results have been variable.^116,121-123 One randomized placebo-controlled trial of PPSV in Africa paradoxically found that vaccination was associated with an increased risk of pneumonia, and there was no evidence of reduced risk of IPD among vaccinated participants.¹²⁴ Follow-up of this cohort confirmed the increase in pneumonia in vaccinated participants but also showed a decrease in all-cause mortality, although participants in this study were not treated with ART.¹²⁵ A study¹²⁶ evaluating the impact of PCV13 vaccination on the rates of IPD in adults with HIV between 2008 and 2018 found that IPD rates remained high despite reductions with the introduction of PCV13. However, use of higher-valent conjugate vaccines might reduce IPD: 11.2% of cases of IPD consisted of additional serotypes contained in PCV15 but not PCV13, and 16.5% of cases of IPD consisted of serotypes in PCV20 but not in PCV15.

In 2021, PCV15 and PCV20 were licensed by the U.S. Food and Drug Administration (FDA) for use in adults¹²⁷ based on safety and immunogenicity data compared with data on PCV13 or PPSV23. Effectiveness data of these vaccines against pneumococcal disease or their durability in providing immunoprotection in adults with HIV currently are not available. One Phase 3 clinical trial of PCV15 followed by PPSV23 8 weeks later in people with HIV demonstrated safety and immunogenicity of this approach.¹²⁸ No clinical data exist for the use of PCV20 in people with HIV.

In 2024, PCV21, which was developed specifically for adults, was approved in the United States. It includes the serotypes that are currently responsible for most cases of IPD in adults.¹²⁹ Overall, 77% to 85% of IPD cases in adults are due to serotypes in PCV21, compared with 54% to 62% in PCV20 and 60% to 67% in PPSV23. However, PCV21 does not include some serotypes contained in previously approved vaccines. One example is serotype 4, which is included in all other PCV formulations and in PPSV23; serotype 4 has recently reemerged in certain geographic areas (Alaska, Colorado, the Navajo Nation, New Mexico, and Oregon), causing outbreaks of pneumococcal disease, especially among people with certain risk factors that often are more common in people with HIV (e.g., homelessness, alcoholism, cigarette smoking, injection drug use, chronic lung disease)¹³⁰

Immune responses to PCV21 were evaluated among adults aged ≥18 years with HIV in one study. When recipients of PCV15 followed by PPSV23 8 weeks later were compared with recipients of PCV21 followed by placebo 8 weeks later, immunogenicity for shared serotypes was comparable, and PCV21 was immunogenic for unique serotypes.¹³¹ There are currently no data on clinical effectiveness of PCV21 in people with HIV.

Recommendations for PCV and PPSV23 in people with HIV depend on their age, receipt of prior doses of pneumococcal vaccine, number of prior doses, and specific vaccines received. In addition, the region’s prevalence of IPD (>30% of IPD cases) caused by serotype 4, patients’ risk factors, and local health department recommendations need to be considered when deciding between PCV21 or PCV20 for vaccine-naive individuals. For people with HIV and CD4 counts >200 cells/mm³, pneumococcal vaccination should not be delayed while awaiting a response to ART. For people with HIV who have a CD4 count <200 cells/mm³, immunogenicity may be improved if pneumococcal vaccination is administered when the CD4 count increases to 200 cells/mm³ or higher on ART. However, data are inconsistent. In some studies, immune responses have been shown to be decreased in response to PCV or to PPSV23 among people with HIV and lower CD4 counts (e.g., <200 or <350 cells/mm³)^132,133; other studies have demonstrated no difference according to CD4 count at the time of vaccination or with delaying vaccinations until after 6 months of ART.^134-136 Thus, delaying administration of pneumococcal vaccines to optimize immune response in those with CD4 counts <200 cells/mm³ must be considered against an increased risk of pneumococcal disease and IPD in this group and any potential barriers to retention in care.

Respiratory Syncytial Virus Vaccine

Available Vaccines

• Adjuvanted protein subunit vaccine (Arexvy, GSK)
• Bivalent protein subunit vaccine (Abrysvo, Pfizer)
• mRNA vaccine (mRESVIA, Moderna)

Summary of Recommendations

• Administration of a single respiratory syncytial virus (RSV) vaccine (Abrysvo, Arexvy, or mRESVIA) to all people with HIV aged ≥75 years is recommended (BIII).
• Administration of a single RSV vaccine for people ages 50 to 74 with HIV and CD4 count <200cells/mm³ or with comorbid chronic conditions that increase risk for severe RSV disease is recommended.
• For pregnant women with HIV, administration of a single RSV vaccine (Abrysvo) between 32 and 36 weeks’ gestation with seasonal administration during September through January in most of the continental United States is recommended (BIII).
• No booster doses are currently recommended (BIII).

Evidence Summary

RSV is a significant cause of lower respiratory tract infection and bronchiolitis worldwide in children aged <5 years and adults aged ≥60 years. RSV vaccine development began in the 1960s; however, early formaldehyde-inactivated RSV vaccines induced a life-threatening inflammatory response during subsequent natural RSV infection in infants.¹³⁷ Following an improved understanding of the structure of RSV, modern vaccine research has developed a myriad of safer approaches, including live attenuated, chimeric, vector-based, subunit proteins, nanoparticle, and nucleic acid vaccines.¹³⁸ Currently, at least 19 RSV vaccines are in clinical trials evaluating efficacy in pediatric, maternal, and adult populations.¹³⁹

In May 2023, the FDA approved the first two RSV vaccines for adults aged ≥60 years: RSVPreF3 (Arexvy) and RSVpreF (Abrysvo). Both vaccines target the prefusion F protein on the viral surface.¹⁴⁰

RSVPreF3 (Arexvy) is an AS01_E-adjuvanted RSV prefusion F protein–based vaccine, approved based on results of a large clinical trial comparing the candidate vaccine to placebo over a median follow-up of 6.7 months.¹⁴¹ The study included 17,922 participants. People with HIV were excluded from the study. Relative to placebo, RSVPreF3 was efficacious in reducing RSV-related lower respiratory tract disease, severe lower respiratory tract disease, and acute respiratory infection by 83%, 94%, and 72%, respectively. Further, this vaccine was generally safe, with most adverse events being transient, mild to moderate, and related to local pain and fatigue. Rare inflammatory neurologic events were reported in three trial participants within 42 days of receipt of the RSVPreF3; all events occurred in trials without a placebo arm. These included one case of Guillain-Barré syndrome (GBS) and two cases of acute disseminated encephalomyelitis (ADEM). Both ADEM cases were based on symptoms and clinical findings, and one case was fatal.

RSVpreF (Abrysvo) is a bivalent RSV prefusion F protein–based vaccine that demonstrated efficacy in a large, randomized clinical trial with a mean follow-up of 7 months.¹⁴² Immunocompromised patients were excluded from this trial. People with well-controlled HIV (viral load <50 copies/mL and CD4 counts >200 cells/mm³ on ART) were eligible, but the number of people with HIV in the trial is not reported. Compared with placebo, RSVpreF reduced RSV-related lower respiratory tract illness with at least two signs or symptoms and with at least three signs or symptoms by 67% and 86%, respectively. RSVpreF reduced RSV-associated acute respiratory illness by 62%. RSVpreF was relatively safe, with higher rates of local reactions in the vaccine (12%) versus placebo (7%), but rates of systemic events were similar. Rare inflammatory neurologic events were reported in three of 34,284 participants, including one case of GBS, one case of Miller Fisher syndrome (GBS variant), and one case of undifferentiated motor-sensory axonal polyneuropathy. A separate clinical trial evaluated maternal RSVpreF versus placebo to determine efficacy in reducing RSV-related illness in newborns and infants.¹⁴³ In interim analysis, RSVpreF was effective in reducing medically attended severe RSV-associated lower respiratory tract illness in infants within 90 days after birth, and no safety concerns were identified. Pregnant women with HIV were excluded from this trial.

mRNA-1345 (mRESVIA) is an mRNA-based RSV vaccine encoding the stabilized RSV prefusion F glycoprotein. In a trial of more than 35,000 participants aged ≥60 years, the vaccine demonstrated greater than 80% efficacy against RSV-related lower respiratory tract disease.¹⁴⁴ Participants with HIV and CD4 count ≥350 cells/mm³ and an undetectable HIV viral load within the past year were permitted to enroll in the trial. The vaccine was generally well tolerated, and no cases of ADEM or GBS were observed.

In June 2024, ACIP recommended that adults aged ≥75 years and adults aged 60 to 74 years with comorbid conditions that increase risk for severe RSV disease receive a single dose of an approved RSV vaccine. A full list of qualifying conditions can be found on the CDC’s Clinical Overview of RSV webpage.¹⁴⁵ In September 2023, ACIP and the American College of Gynecology both recommended seasonal administration of one dose of RSV vaccine for pregnant women during weeks 32 through 36 of pregnancy, ideally at least 14 days before delivery.

In the absence of additional data regarding immunologic response, clinical efficacy, and safety in people with HIV, these recommendations are aligned with the ACIP guidance for the general population. For people with HIV, offer a single RSV vaccine (Abrysvo, Arexvy, or mRESVIA) to individuals aged ≥75 years and those aged 50 to 74 years with qualifying comorbid conditions (BIII). Individuals aged 50 to 74 years with HIV and CD4 <200 cells/mm³ are eligible for RSV vaccination, although the vaccines have not been studied in this population, and many clinicians may choose to wait for immune reconstitution prior to administering the vaccine (BIII). Optimally, vaccination should occur before the onset of the fall and winter RSV season.

For pregnant women with HIV, administer a single RSV vaccine (Abrysvo) between 32 to 36 weeks gestation with seasonal administration during September through January in most of the continental United States (BIII). The adjuvanted vaccine, Arexvy, and the mRNA vaccine, mRESVIA, have not been studied in pregnancy and should not be used as an alternative. In locations where the seasonality of RSV differs from the continental United States (e.g., tropical climates, the Southern hemisphere), providers should follow local guidance on timing of administration. Data regarding immunologic response to the vaccine and clinical outcomes are notably lacking in people with HIV.

Tetanus, Diphtheria, and Pertussis Vaccine

Available Vaccines

• Tdap: Tetanus, diphtheria, and pertussis
  • Adacel (Sanofi Pasteur)
  • Boostrix (GSK)
• Td: Tetanus and diphtheria
  • TENIVAC (Sanofi Pasteur)

Note: DTaP vaccines (diphtheria, tetanus, and pertussis) are only for babies and young children and therefore are not covered in these guidelines.

Summary of Recommendations

• Administer the combination tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) once if the person with HIV has not been vaccinated at age 11 or older, and then tetanus and diphtheria toxoids vaccine (Td) or Tdap every 10 years thereafter (AII).
• For pregnant women with HIV, administer one dose of Tdap during each pregnancy, preferably between 27 weeks and 36 weeks gestation (AIII).
• For adolescents and adults with HIV who have not received the primary vaccination series for tetanus, diphtheria, or pertussis, administer one dose of Tdap followed by one dose of Td or Tdap at least 4 weeks after Tdap, and another dose of Td or Tdap 6 months to 12 months after the last Td or Tdap. Tdap can be substituted for any Td dose and is always preferred as the first dose (AIII).

Evidence Summary

Antibody response to tetanus and diphtheria vaccination varies by CD4 count. For individuals with advanced HIV and a low CD4 count, immunologic response is attenuated for both tetanus and diphtheria when compared with people without HIV.^146,147 For people with CD4 count >300 cells/mm³, antibody response to tetanus vaccination is similar to the general population, whereas response to diphtheria remains diminished.^146-148 Limited data exist on the efficacy of pertussis vaccination in this population.

Two Tdap vaccines for individuals aged ≥10 years are available in the United States (Adacel and Boostrix). Both vaccines are inactivated and considered safe to administer at any CD4 count. People with HIV should receive vaccination for tetanus, diphtheria, and pertussis on the same schedule as individuals without HIV. All adults not previously vaccinated should receive a single dose of Tdap, followed by a Td or Tdap booster every 10 years.

Varicella Vaccine

Available Vaccine

• Live attenuated varicella vaccine (VAR)
  • Varivax (Merck)

Summary of Recommendations

• People with HIV with any of the following have presumed immunity to varicella: receipt of two doses of either Varivax or MMRV, diagnosis of varicella or herpes zoster (shingles) by a health care provider, or laboratory evidence of immunity or disease.
• For adults and adolescents with HIV who are varicella nonimmune with CD4 count ≥200 cells/mm³, administer two doses of VAR 4 to 8 weeks apart (BIII).
• VAR is contraindicated for people with HIV with CD4 count <200 cells/mm³ (AIII).
• VAR is contraindicated during pregnancy (AIII). However, for non-immune pregnant women with HIV and CD4 count ≥200 cells/mm³, VAR should be administered immediately after delivery with a subsequent dose administered at the 6-week postpartum visit (AIII).
• If vaccination results in disease due to live attenuated vaccine virus, antiviral treatment is recommended (AIII). See the Treating Disease section of the Varicella-Zoster Virus Disease chapter for dosing.
• If post-exposure varicella-zoster immune globulin (VariZIG) has been administered, an interval of at least 5 months is recommended before varicella vaccination (CIII).
• If post-exposure acyclovir, famiclovir, or valacyclovir have been administered, an interval of at least 24 hours is recommended before varicella vaccination (CIII).
• Post-exposure varicella vaccination for people with HIV is not recommended (CIII).

Evidence Summary

The live attenuated varicella vaccine (Varivax) is safe and immunogenic in children and adolescents with HIV who have relatively preserved immune systems (CD4 percentage ≥15%)^149-152 and is recommended for this population of children and adolescents with HIV.¹⁵³ Varicella vaccination of children and adolescents with HIV also reduces the risk of subsequent herpes zoster.^152,154

Adults who are seronegative for varicella-zoster virus (VZV) are potential candidates for varicella vaccination. Given the high prevalence of VZV seropositivity in adults, administration of varicella vaccine for adults will be infrequent. Some experts would serologically screen adults with HIV without a history of prior varicella infection or varicella vaccination for VZV IgG. However, the value of this approach may be limited by the lack of sensitivity of commercially available VZV antibody assays (particularly for vaccine-induced antibody).^155,156 No studies have evaluated the clinical efficacy of the vaccine in adolescents or adults with HIV, but varicella vaccination (two doses, administered 4 to 8 weeks apart) is recommended for VZV-susceptible people with HIV at least age 18 years with CD4 counts ≥200 cells/mm³(BIII).¹⁵⁷

If post-exposure varicella-zoster immune globulin (VariZIG) has been administered (see below), an interval of at least 5 months is recommended before varicella vaccination (CIII).¹⁵⁸ If post-exposure acyclovir, famciclovir, or valacyclovir has been administered, an interval of at least 24 hours after the last dose is recommended before varicella vaccination (CIII).

Herpes Zoster Vaccine

See “Vaccination to Prevent Reactivation Disease (Herpes Zoster)” in the Varicella-Zoster Virus Disease section for detailed guidance on immunization against zoster, as well as the evidence summary. Herpes zoster vaccine has not been studied for prevention against primary varicella infection.

Available Vaccine

• Recombinant adjuvanted zoster vaccine (RZV)
  • Shingrix (GSK)

Summary of Recommendations

• For people with HIV aged ≥18 years, regardless of CD4 count or previous history of herpes zoster, administer two doses of RZV 2 to 6 months apart (AIII).
• For individuals who are expected to have worsening immunosuppression (e.g., initiating immunosuppressive therapy, ART nonadherence, or ineffective ART) in the near future, a shorter vaccination schedule can be used: two doses administered 1 to 2 months apart (CIII).
• Following initiation of ART, some experts would administer the RZV vaccination series after CD4 count recovery (≥200) and/or virologic suppression are achieved, to ensure a robust vaccine response (CIII).
• Individuals with herpes zoster who did not previously receive RZV vaccine can be vaccinated after their episode resolves to provide protection from recurrent episodes (CIII). Vaccination is recommended following resolution of primary episode, preferably within 1 year, but may be administered at any point after the primary episode has resolved (CIII).
• Do not administer RZV to people experiencing an acute episode of herpes zoster (AIII) or an episode of active inflammation due to VZV-related inflammatory eye disease (AIII). 
• People who were previously vaccinated with attenuated zoster vaccine live (ZVL, Zostavax) should be revaccinated with RZV (AIII).
• Data on RZV during pregnancy is insufficient. Consider administering after delivery (BIII). 
• RZV vaccine is not recommended or approved for prevention of primary varicella infection (AIII).

Evidence Summary

Initial FDA approval for Shingrix was based on pivotal Phase 3 randomized, placebo-controlled clinical trials involving >30,000 participants aged ≥50 years in which the vaccine efficacy against herpes zoster in vaccinated participants was 97.2% overall and 91.3% in those aged ≥70 years.^159,160 The most common solicited adverse reactions in vaccine recipients were pain (78% of recipients), myalgia (45%), and fatigue (45%), with Grade 3 injection site reactions (pain, redness, and swelling) reported in 9.4% of vaccine recipients and Grade 3 solicited systemic events (myalgia, fatigue, headache, fever, and gastrointestinal symptoms) reported by 10.8% of vaccine recipients.^161,162 Systemic Grade 3 reactions were reported more frequently after Dose 2 than after Dose 1.¹⁶² 

Data on use of RZV in people with HIV are limited, but two studies of immune response to the recombinant zoster vaccine in people with HIV are ongoing.^163,164 In one study of people with HIV, RZV increased humoral and cell-mediated immunity to VZV after two doses, including among people with CD4 counts <200 cells/mm³. Based on these very limited data in people with HIV, the vaccine appears safe and immunogenic. No efficacy data are available for RZV among people with HIV. 

No data identify the optimal timing of vaccination for people with HIV with a CD4 count <200 cells/mm³ or who are not suppressed virologically on ART, but ACIP recommends vaccination of all people with HIV regardless of CD4 count and HIV viral load. Following initiation of ART, some experts would administer the RZV vaccination series after CD4 count recovery (≥200) and/or virologic suppression are achieved (CIII).

Post-infection vaccination has been shown to be safe and immunogenic in the general population,¹⁶⁵ and most recurrences occur after 1 year (interquartile ranges vary from 1–2.3 years to 1.4–4.1 years based on age group studied).¹⁶⁶ Therefore, vaccination is recommended any time between resolution of primary episode and 1-year later if possible, but can be given at any point in the future as well (CIII). The optimal timepoint for vaccination in this scenario has not been studied in any population.

Prior to availability of RZV, a 1-dose attenuated live-zoster virus vaccine (Zostavax) for prevention of herpes zoster was FDA-approved and recommended for use in immunocompetent adults aged ≥50 years. It is no longer available or recommended for use in the United States. Those who previously received ZVL should be revaccinated with RZV (AIII).

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