RecruitingPhase 1Phase 2NCT05580458

Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population

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)


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

225 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and immune response to a shingles vaccine (recombinant varicella zoster virus vaccine) in people living with HIV, including those with lower immune cell counts (CD4 below 300) and those with higher counts. A healthy control group without HIV is also included for comparison. **You may be eligible if...** - You are 18 or older (for HIV-positive participants) - You are HIV-positive and currently on antiretroviral treatment - You have a primary care provider - You are willing to use contraception if you can become pregnant - Healthy volunteers (HIV-negative) may also be eligible **You may NOT be eligible if...** - You have previously had a severe allergic reaction to a varicella/shingles vaccine - You have a condition or are taking medications that severely weaken your immune system (beyond HIV itself) - You are pregnant or planning to become pregnant during the study - Other safety-related reasons determined by the study team Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALShingrix

Shingrix is a recombinant, adjuvanted vaccine for prevention of herpes zoster. It is supplied as lyophilized recombinant VZV surface gE antigen for reconstitution with AS01B adjuvant suspension. Each Shingrix dose will be 0.5mL and administered by IM injection in the deltoid region of the upper arm.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05580458


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