Shingrix Vaccine Study in People with HIV and Healthy Volunteers
This study is looking at the Shingrix vaccine, which helps prevent shingles (a painful rash caused by the chickenpox virus). Researchers want to understand how well Shingrix works and how safe it is in people living with HIV, both those with lower and higher CD4 counts (a measure of immune health). They are also studying healthy volunteers aged 50 and older. The main goal is to see how the immune system responds to the vaccine by measuring specific antibody levels at 3 and 12 months after vaccination. The study is currently recruiting participants.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving Shingrix. It plans to enroll 225 participants, including people with HIV and healthy volunteers.
- What's involved
- You will have at least 4 clinic visits over 1 year. This includes a screening visit, a physical exam, blood and urine tests, and receiving Shingrix as a shot in your upper arm at your first visit and again at month 2.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your immune response will be checked at 3 and 12 months after vaccination to see how well the vaccine worked.
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NCT05580458
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
Recruiting
PHASE1Ages 18+InterventionalPreventionNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~225 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Shingrix
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)
Measured over Months 3 and 12
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Maura M Manion, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
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 90 days of screening and documented viral suppression defined as viral load consistently \<100 copies/mL with at least one documented viral load \< 40 copies/mL within 12 months prior to 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 12 months prior to screening visit).
No active/uncontrolled opportunistic infections (patients on chronic maintenance therapy would be considered as controlled).
\>= 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).
Exclusion
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.
Immunocompromised (other than HIV for the PWH cohort) within the past 6 months (eg, due to a malignancy other than skin cancer).
Current moderate or severe acute illness (ie, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the principal investigator, would make the subject unsuitable for the study.
Pregnancy or breastfeeding.
Receipt of an investigational agent, investigational vaccine, or licensed live virus vaccine within 30 days prior to screening.
Planned receipt of any vaccine (investigational or ACIP-recommended) between months 0 and 2 except for the tetanus, diphtheria, and pertussis vaccine \[TDaP\], Pneumovax, inactivated influenza vaccines, and COVID-19 vaccine which may be given at least 8 days before and/or at least 14 days after each study agent injection (at month 0/month 2).
Administration of immunoglobulins or any blood products within 90 days preceding the first dose of vaccine or planned administration during the study period.
Chronic administration (\>= 15 consecutive days) of immunosuppressive or other immune-modifying drugs within 6 months before screening. (Prednisone \< 20 mg/day or equivalent, corticosteroid nasal spray or inhaler, and topical steroids are not exclusionary).
Uncontrolled psychiatric disease per physician evaluation, current substance use, or inappropriate conduct unsuitable for a research study.
Any condition that could compromise, in the investigator's opinion, the participant's safety or the study outcomes.
What this trial measures
- Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)Months 3 and 12
Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH based upon CD4 count \< 300 and \>= 300.