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.
Able to provide informed consent.
Hormonal contraception.
Male or female condom.
Diaphragm or cervical cap with a spermicide.
Previous receipt of Shingrix vaccine at any time.
Receipt of Zostavax within the past 12 months.
History of severe allergic reaction to any component of Shingrix.
Diagnosed varicella or herpes zoster episode within the past 1 month. Subject will be eligible for SHINGRIX vaccine once symptoms of herpes zoster episode have resolved.
Single group
Shingrix
Biological/VaccineShingrix 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.
Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)
Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH based upon CD4 count \< 300 and \>= 300.
Fold change of anti-gE antibody concentrations evaluated regularly through the end of study in PWH and healthy volunteers
Compare vaccine immunogenicity in PWH versus healthy volunteers.
Grade 3 and/or Grade 4 Shingrix ARs (solicited and unsolicited local and systemic).
Evaluate grade 3 and 4 safety responses in PWH, based upon age (\< 50 and \>= 50), and healthy volunteers.
Grade 3 and/or Grade 4 Shingrix ARs (solicited and unsolicited local and systemic).
Evaluate grade 3 and 4 safety responses in PWH, based upon CD4 count (\< 300 and \>= 300), and healthy volunteers.
Fold change of anti-gE antibody concentrations evaluated regularly through the end of study by age (< 50 and >= 50)
Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH by age (\< 50 and \>= 50 years).
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