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

Conditions

• Herpes Zoster

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Shingrix — BIOLOGICAL
  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.

Study Details

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.

Key Dates

Start date

Mar 13, 2023

Status verified

Apr 2026

Primary completion

Feb 1, 2027

Completion

Oct 1, 2027

Study Design

Enrollment

225 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Shingrix
  Shingrix will be administered in two 0.5-mL doses approximately 2 months apart.

Primary Outcome Measure

Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300) [ Time Frame: Months 3 and 12 ]

Central Contacts

• Maura M Manion, M.D.
  (301) 312-2103
  [email protected]

Locations (1)

Find similar trials in Bethesda, MD