Can shingrix shield HIV patients from shingles?
NCT ID NCT05580458
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 13 times
Summary
This study tests the Shingrix vaccine in people with HIV and healthy volunteers to see how well it boosts immunity against shingles. Participants receive two shots two months apart and are followed for a year. The goal is to understand if the vaccine works safely in those with different CD4 counts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shingrix vaccine
- What this could lead to
- If successful, this study could show that Shingrix works well in people with HIV, helping protect them from shingles.
- What could go wrong
- This is an early-phase trial with only 225 participants, so results may not apply to everyone. The vaccine may cause side effects like pain or fever.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: General Inclusion Criteria: 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 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). 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). EXCLUSION CRITERIA: Individuals meeting any of the following criteria will be excluded from study participation: * 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. Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, race, ethnicity, socioeconomic status, etc, except for age. Medical record review may be used for determining eligibility. If a clinical laboratory evaluation is available for review at the screening timepoint, but was obtained prior to protocol consent, the laboratory test does not have to be repeated for the purposes of confirming eligibility under the protocol.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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