Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)
Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18. Researchers want to learn more about how people with HIV respond to Shingrix.
Objective: To learn how Shingrix affects the immune response in people with HIV.
Eligibility: People aged 18 years and older with HIV. Healthy people aged 50 years or older are also needed.
Design: Participants will have at least 4 clinic visits in 1 year. Participants will be screened. They will have a physical exam with blood and urine tests. At their first visit, participants will receive Shingrix as a shot in the upper arm. They will have a rectal swab; a cotton swab will be inserted into the rectum and rotated gently to collect bacteria. Participants will receive a second shot of Shingrix 2 months after the first one. They will visit the clinic again 3 and 12 months after the first shot. Participants will receive a 28-day memory tool. They will write down their symptoms between clinic visits. They will have up to 4 phone calls to talk about side effects of the shot. Participants may undergo apheresis: They will lie still while blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in their other arm.
∙ Individuals must meet all of the following criteria to be eligible for study participation:
• Able to provide informed consent.
• Participants of childbearing potential must agree to use at least 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 3. Acceptable methods of contraception include the following:
‣ Hormonal contraception.
⁃ Male or female condom.
⁃ Diaphragm or cervical cap with a spermicide.
⁃ Intrauterine device.
• Has a primary care provider.
∙ Additional Inclusion Criteria for People with HIV:
• PWH must also meet all the following criteria to be eligible for study participation:
• \>= 18 years of age.
• Seropositive for HIV-1 (documented or confirmed at screening).
• Documented viral load \< 100 copies/mL within 30 days of screening and documented suppression \< 40 copies/mL within 6 months of screening.
• Currently on a stable antiretroviral regimen (minimum of 6 months of a stable ART regimen; changes for side effects, drug interaction, or convenience allowed), or is an elite controller (maintains undetectable viral loads in the absence of any treatment for a period of one year prior to screening visit).
• No active/uncontrolled opportunistic infections (patients on chronic maintenance therapy would be considered as controlled).
∙ Additional Inclusion Criteria for Healthy Volunteers:
∙ Healthy volunteers must also meet all of the following criteria to be eligible for study participation:
• \>= 50 years of age.
• No uncontrolled chronic medical issues that per the discretion of the PI or designee would compromise the safety of the research participant.
• No underlying immunodeficiencies (including negative HIV test at screening).