NCT05580458 · National Institute of Allergy and Infectious Diseases (NIAID)
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
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Shingrix
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.
Primary outcome 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)
Time frame: Months 3 and 12
Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH based upon CD4 count \< 300 and \>= 300.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Bethesda, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations