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)
  • The following vaccines have specific recommendations related to HIV status:
    • COVID-19
    • Hepatitis A (HAV)
    • Hepatitis B (HBV)
    • 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 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

• mRNA vaccines (Spikevax, Moderna; Comirnaty, Pfizer-BioNTech)
• Adjuvanted protein subunit vaccine (Novavax)

Summary of Recommendations

• For adults and children >5 years of age with HIV, administer a dose of the updated COVID-19 vaccine (once available) regardless of their CD4 count or HIV viral load (AII).
• Individuals with advanced or untreated HIV are considered moderately or severely immunocompromised and may receive one additional dose at least 8 weeks after the last COVID-‍19 vaccine dose (AIII).
  • Note: Advanced HIV is defined as people with CD4 count <200 cells/mm³, a history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV.
• For current COVID-19 vaccination recommendations, please visit the Centers for Disease Control and Prevention (CDC) website on the Use of COVID-19 Vaccines in the United States.

Evidence Summary

Worse outcomes for people with HIV and COVID-19, including high COVID-19 mortality rates, have been reported in cohort studies from the United States, the United Kingdom, and South Africa.^1-8 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.⁹ 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. This increased risk was observed even in patients who had achieved virologic suppression of HIV.⁶ 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, without an association between viral load suppression and COVID-19 disease severity.¹⁰

Most people with HIV develop antibody responses to vaccination comparable to those measured in people without HIV.^11-16 However, responses may be lower and antibody titers decline faster, particularly for individuals^13-15 with CD4 counts <200 cells/mm³. Rates of breakthrough infections after vaccination are higher among individuals with HIV, with vaccine efficacy declining sooner than in HIV-negative matched cohorts.^17-19 Breakthrough infections showed no association with viral load suppression, though fewer breakthroughs¹⁷ were seen in individuals with CD4 counts ≥500 cells/mm³. Vaccine efficacy against more severe outcomes (e.g., hospitalization, intensive care unit admission, or death) has been more robust than protection against infection or mild disease.²⁰

For individuals with advanced or untreated HIV, the lower seroresponse rates and reduced vaccine effectiveness compared to individuals without immunocompromise support recommendations for additional booster doses.²¹

Three COVID-19 vaccines are available in the United States: two mRNA formulations (Moderna and Pfizer) and one adjuvanted recombinant protein (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.²²

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).^21,23 Those with severe immunosuppression may have a diminished immune response to the vaccine and therefore may receive one additional dose at least 8 weeks after the last COVID-19 vaccine dose. For current COVID-19 vaccination recommendations, please visit the CDC website on the Use of COVID-19 Vaccines in the United States.

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

• Administer a two-dose series (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]) of single-antigen hepatitis A vaccine (HepA) or a three-dose series (0, 1, and 6 months) of the combined hepatitis A and hepatitis B vaccine (HepA-HepB, Twinrix) to any person without evidence of immunity to HAV (and for the combined vaccine, without evidence of immunity to HAV or HBV) (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/mm³who have ongoing risk for HAV 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/mm³who do not have ongoing risk for HAV, waiting for a CD4 count >200 cells/mm³ prior to immunization is an option (BIII).

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 HAV vaccine and IgG 0.1 mL/kg simultaneously in different anatomical sites as soon as possible, ideally within 2 weeks of exposure. Complete the HAV vaccine series following the dosing intervals for the selected vaccine. 

Hepatitis B Vaccine

See the “Preventing Disease” section in Hepatitis B Virus (HBV) 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)
• Recombinant hepatitis B vaccine (trivalent; contains S, pre-S1, and pre-S2 HBV surface proteins)
  • HepB (PreHevbrio, VBI Vaccines)
• 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 infection (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 acquiring 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, there are no data but clinicians can consider a third dose of HepBCpG (Heplisav-B) IM at 24 weeks after first dose or consider the three-antigen vaccine, PreHevbrio IM, at 0, 4, and 24 weeks (CIII).
• Assess for Vaccine Response
  • Anti-HBs should be obtained 4 weeks after completion of the vaccine series to document response to HepB vaccination, defined as anti-HBs ≥10 mIU/ml (AII).
• Vaccination Schedule for People With Isolated Anti-HBc
  • One standard 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 the Hepatitis B Virus (HBV) 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 vaccine series and have documented antibody response, no additional vaccine is needed.
• For people who have been exposed and who received a complete HepB vaccine series without documentation of antibody response, administer a single dose of HepB vaccine.
• For people who have been exposed and have not received any HepB vaccine or have not received a complete HepB vaccine series, administer or complete an HepB vaccine 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 (HPV) 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 gender, administer three doses of the recombinant HPV nonavalent 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.^24-27
• 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 nonavalent vaccine, but data are lacking for defining 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 people 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).²⁸

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: HA and neuraminidase (NA). Although vaccine-induced immunity to the surface antigens HA and NA reduces the likelihood of infection,^29,30 the frequent emergence of antigenic variants through antigenic drift³¹ (i.e., point mutations and recombination events within a subtype) is the virologic basis for seasonal epidemics and necessitates revaccination each season.³²

Some studies of influenza have noted higher hospitalization rates^33-36 and increased mortality^36,37  among people with HIV; however, these findings have not been observed in all settings.³⁸ Increased morbidity may be greatest for people with HIV not on antiretroviral (ARV) drugs or with advanced disease. People with HIV are at high risk of serious influenza-related complications. For more information, see the CDC’s website on Flu and People Living With HIV.

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.^39-41 Among people with a low CD4 count or who have advanced HIV disease, IIV might not induce protective antibody titers.^41-43 In one study, markers of inflammation in older people (≥60 years) with HIV were associated with lower post-vaccination influenza antibody titers.⁴⁴ In people with HIV, a second dose of vaccine does not improve immune response,^42,45 and intradermal influenza vaccine dosing did not improve the immune response compared with intramuscular dosing.⁴⁶

Influenza vaccines are trivalent (two A components and one B component) with formulations that 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,³³ 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 ARV treatment and 157 who were ARV treatment 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%).⁴⁷

Several clinical studies also have evaluated the immunogenicity of influenza vaccine in people with HIV. In a randomized study⁴⁸ 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.⁴⁹

Although booster doses can make the influenza vaccine more effective, that benefit is limited to specific groups, such as solid-organ transplant recipients.⁵⁰ 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.⁴⁵ 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.²⁸ 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 CDC. For adults aged ≥65 years, high-dose IIV,⁵¹ adjuvanted IIV,⁵² or recombinant influenza vaccine⁵³ are preferentially recommended over standard-dose unadjuvanted vaccines based on data suggesting higher efficacy in preventing invasive pneumococcal disease in this age group.⁵⁴

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.⁵⁵ Although unintentional administration of LAIV to adults with HIV has been well tolerated,⁵⁶ 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 and/or had documentation of receipt of MMR vaccine and/or has laboratory evidence of immunity or disease) (AIII).
• The MMR vaccine is not recommended during pregnancy.
• People of childbearing potential who get the MMR vaccine should wait 4 weeks before getting pregnant.
• For pregnant people 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 antiretroviral therapy (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 the 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 those 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.⁵⁷ Worldwide, the incidence of measles has continued to rise with several ongoing outbreaks. The World Health Organization reported that its European region experienced greater than 30,000 cases in 2022 up from fewer than 1,000 in 2021, and 51 countries had large disruptive outbreaks in 2023. The increase in cases is largely attributable to decreased rates of vaccination. Current information regarding outbreaks can be found on the CDC website Measles Cases and Outbreaks.⁵⁸

With a resurgence of measles both domestically⁵⁹ and globally,⁶⁰ people with HIV should be assessed for immunity or prior vaccination. Acceptable evidence of immunity includes being born before 1957, documented evidence of two doses of the MMR vaccine, or presence of positive antibody titers.

Several studies from the 1990s found that 90% to 95% of adults with HIV were immune to measles.^61-63 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. However, in a more recent study, the measles seroprevalence rate was 70.3%. Similarly, people with HIV appear to retain immunity to mumps and rubella even after acquisition of HIV.⁶⁴

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.

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.^65,66 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.^64,67,68 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)

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 previously vaccinated (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).⁶⁹
• 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 the most common cause of bacterial meningitis among children and young adults in the United States. Surveillance data collected from 1998 to 2007 identified 2,262 cases of meningococcal disease from a sample of 13% of the U.S. population from several states. All available formulations of meningococcal vaccine are inactivated. Two MenACWY vaccines and one MenABCWY meningococcal vaccine are currently licensed and available in the United States: (1) meningococcal groups A, C, W, and Y oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM, Menveo); (2) meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT, MenQuadfi); and meningococcal groups A, C, W, and Y polysaccharide tetanus toxoid conjugate vaccine plus meningococcal group B recombinant FHbp antigens (MenACWY-TT plus MenB-FHbp; Penbraya). 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 11 to 12 years and a second dose at 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 (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.⁷⁰

A growing body of evidence supports an increased risk of meningococcal disease in people with HIV. Studies have shown a five- to 24-fold increased risk of meningococcal disease in people with HIV compared with people without HIV^71-73; low CD4 count and high HIV viral load are associated with increased risk.^74,75 From 2000 to 2011, the average annual incidence rate of invasive meningococcal disease was 0.39 cases per 100,000 people. People with HIV with a lower CD4 count are at higher risk of invasive disease.⁷⁴ Most meningococcal infections among people with HIV in the United States have been caused by serogroups C, W, or Y.⁷⁵ In 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.⁷⁶

The safety and immunogenicity of MenACWY-D vaccine have been evaluated only in people with HIV 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,⁷⁷ 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 with HIV (age 16–23 years) can be offered MenB vaccination with shared decision-making (CIII).⁶⁹ 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.⁷⁰ Two MenB vaccines are available: MenB-4C (Bexsero; two-dose series given at 0 and 1 month) and MenB-FHbp (Trumenba; people with HIV should receive the three-dose series given at 0, 1–2, and 6 months rather than the two-dose option). MenB-FHbp consists of two purified recombinant lipidated FHbp antigens. MenB-4C consists of three recombinant proteins in addition to outer membrane vesicles that contain outer membrane protein porin A. MenB vaccines are not interchangeable; the same product must be used for all doses in the series. The pentavalent meningococcal vaccine contains the MenB-FHbp vaccine. A MenB vaccine booster may be indicated if a person previously vaccinated is identified as being at increased risk during a MenB outbreak. 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.

Urban outbreaks of meningococcal meningitis have been reported among men who have sex with men in the United States, in men both with and without HIV. 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 who have sex with men without HIV.⁷⁸

Pregnant and lactating people with HIV should receive MenACWY vaccine if indicated (AIII). There have not been safety signals related to maternal and neonatal adverse events (including spontaneous abortion and birth defects) with MenACWY vaccine in clinical trial or in post-licensure surveillance.^79-83 Because limited data are available for MenB vaccination during pregnancy, vaccination with MenB should be deferred unless the pregnant person is at increased risk and, after consultation with their health care provider, the benefits of vaccination are considered to outweigh the potential risks (CIII).⁷⁰

Mpox Vaccine

See the “Preventing Disease” section in Mpox for detailed guidance on immunization against mpox, as well as the evidence summary.

Available Vaccines

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

Summary of Recommendations

For Vaccination

• Mpox vaccination with live nonreplicating vaccinia vaccine, sold as JYNNEOS in the United States, should be offered to all people with HIV, including those who are pregnant or breastfeeding who have potential for mpox exposure or anticipate potential exposure to mpox per CDC interim clinical considerations (BII), as well as any other people with HIV who request vaccination (CII).
• JYNNEOS is the preferred vaccine before mpox exposure and is safe to use in people with HIV; administer JYNNEOS in two doses (0.5 mL subcutaneous [preferred] or 0.1 mL intradermal [alternative]) 4 weeks (28 days) apart (AII).
• If the second dose is not administered during the recommended interval, it should be administered as soon as possible (CIII). There is no need to restart or add doses to the series if there is an extended interval between doses (CIII).
• People who received smallpox vaccination more than 10 years ago should still receive two doses of JYNNEOS (CIII).
• Administration of live replicating vaccinia vaccines (i.e., ACAM2000) to pregnant, breastfeeding, or immunocompromised individuals, including people with HIV, is contraindicated (AII).

For Post-Exposure Prophylaxis

• For unvaccinated people with HIV who experience a known or presumed exposure, including to those who are pregnant or breastfeeding, administer a complete series of JYNNEOS as soon as possible, ideally within 4 to 14 days after exposure (BII).

For current information on the state of the outbreak and vaccination recommendation criteria, please visit the CDC’s Mpox webpage. JYNNEOS has been demonstrated to be both safe for people with HIV and equally immunogenic compared with people without HIV.^84-86 However, these studies were limited to people who were virologically suppressed and had a CD4 count >100 cells/mm³. Immunogenicity among people with HIV who are not virologically suppressed or have a lower CD4 count remains unknown.

Recent studies indicate that JYNNEOS is effective against mpox.^87-90 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.^90-93 However, all studies to date have had insufficient data to assess effectiveness of JYNNEOS against mpox by HIV status or CD4 count, and immunologic correlates of protection have not yet been established.

Pneumococcal Vaccine

See the “Preventing Disease” section in Community-Acquired Pneumonia for detailed guidance on immunization against pneumococcal disease, as well as the evidence summary.

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

For all people with HIV without a history of pneumococcal vaccination or with unknown vaccine history:

• Administer either 20-valent pneumococcal conjugate vaccine (PCV20) or PCV15 (AII).
• 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.

• People with HIV who received PCV13 and were 65 years or older when they received a dose of PPSV23 do not require further doses of PPSV23. Shared clinical decision-making is recommended regarding administration of PCV20 for adults aged ≥65 years who completed their vaccine series with both PCV13 and PPSV23. If a decision to administer PCV20 is made, a dose of PCV20 is recommended at least 5 years after the last pneumococcal vaccine dose (CIII).
• For people with HIV who received PCV13 and were younger than 65 when they received a dose of PPSV23, one dose of PCV20 administered at least 5 years after may be used to complete their pneumococcal vaccinations (CIII) or additional doses of PPSV23 are recommended as indicated below (BIII).
  • People with HIV who have received PCV13 and PPSV23 at age <65 should receive a second dose of PPSV23 at least 5 years after the first dose. If they are age 65 or older at the time of their second dose, they do not require additional doses of PPSV23.
  • If they were <65 at the time of the second dose, they should receive a third and final dose at or after age 65, at least 5 years after the second PPSV23 dose.
• People with HIV who have only received PPSV23 may receive a PCV (either PCV20 or PCV15) ≥1 year after their last PPSV23 dose to complete their pneumococcal vaccination series (BIII).
• People with HIV who previously received only the PCV13 should receive one dose of PCV20 at least 1 year later or receive PPSV23 at least 8 weeks later and then complete the PPSV23 series as recommended above (BIII).
• In June 2024, the ACIP recommended 21-valent PCV (PCV21) as an option for adults aged ≥19 years who are currently recommended to receive PCV15 or PCV20. Data and recommendations for PCV21 are currently under review in this guideline.

Respiratory Syncytial Virus

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 vaccine (RSV) (Abrysvo, Arexvy, or mRESVIA) to all people with HIV >75 years old is recommended (CIII).
• Administration of a single RSV vaccine for people ages 60 to 74 with HIV and CD4 <200cells/mm³ or with comorbid chronic conditions that increase risk for severe RSV disease is recommended..
• For pregnant people 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 (CIII).
• No booster doses are currently recommended (CIII).

Evidence Summary

RSV is a significant cause of lower respiratory tract infection and bronchiolitis worldwide in children <5 years and adults ≥60 years of age. 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.⁹⁴ 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.⁹⁵ Currently there are at least 19 RSV vaccines in clinical trials evaluating efficacy in pediatric, pregnant, and adult populations.⁹⁶

In May 2023, the United States Food and Drug Administration approved the first two RSV vaccines for adults ≥60 years of age: RSVPreF3 (Arexvy) and RSVpreF (Abrysvo). Both vaccines target the prefusion F protein on the viral surface.⁹⁷

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.⁹⁸ 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.⁹⁹ 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 to 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 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 RSVpreF versus placebo in pregnant people to determine efficacy in reducing RSV-related illness in newborns and infants.¹⁰⁰ 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 people 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 60 years and older, the vaccine demonstrated greater than 80% efficacy against RSV-related lower respiratory tract disease.¹⁰¹ 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, the ACIP recommended that adults 75 years and older and adults 60 to 74 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 webpage.¹⁰² In September 2023, the ACIP and the American College of Gynecology both recommended seasonal administration of one dose of RSV vaccine for pregnant people 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 patients 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 between 60 to 74 with qualifying comorbid conditions (CIII). Individuals aged 60 to 74 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 (CIII). Optimally, vaccination should occur before the onset of the fall and winter RSV season.

For pregnant people 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 (CIII). 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 people 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 to HIV-uninfected controls.^103,104 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.^103-105 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

See “Vaccination to Prevent Primary Infection (Varicella)” in the Varicella-Zoster Virus Disease section for detailed guidance on immunization against varicella, as well as the evidence summary.

Available Vaccines

• Live attenuated varicella vaccine
  • Varivax (Merck)

Summary of Recommendations

• People with HIV with any of the following have presumed immunity to varicella: receipt of two doses of varicella vaccine (Varivax or MMRV), diagnosis of varicella or herpes zoster (shingles) by a health care provider, or laboratory evidence of immunity or disease.
• For people with HIV who are varicella nonimmune with CD4 count ≥200 cells/mm³, administer two doses of varicella vaccine (VAR) 4 to 8 weeks apart (BIII).
• VAR is contraindicated for people with HIV with CD4 count <200 cells/mm³ (AIII).
• VAR is not recommended during pregnancy (AIII).

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 Vaccines

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

Summary of Recommendations

• For people with HIV ≥18 years, administer two doses of RZV at 0 and 2 to 6 months (AIII).
• Consider delaying vaccination until the patient is virologically suppressed on ART (CIII) or until the CD4 count is ≥200 cells/mm³ to ensure a robust vaccine response (CIII).
• People with HIV ≥18 years should receive RZV regardless of previous history of herpes zoster or previous receipt of zoster vaccine live (no longer available).
• Do not give RZV (Shingrix) during an acute episode of herpes zoster (AIII).
• RZV is not recommended during pregnancy (AIII).

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