Evaluating the Shingrix vaccine in people with HIV and healthy adults

Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)

This study is testing how well the Shingrix vaccine works and how safe it is for people with HIV and healthy adults over 50.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: Prednisone
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT05580458 on ClinicalTrials.gov

What this trial studies

This phase 1/2 open-label study aims to assess the safety and immune response of the Shingrix vaccine in individuals aged 18 and older with HIV, as well as healthy volunteers aged 50 and older. Participants will receive two doses of the vaccine, with follow-up visits to monitor adverse events and immune responses through blood tests. The study will compare the vaccine's effectiveness based on CD4 counts and age groups, providing insights into how people with HIV respond to the vaccine compared to healthy individuals.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older with HIV and healthy adults aged 50 and older.

Not a fit: Patients who are not living with HIV and are under 50 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance vaccination strategies for preventing shingles in people living with HIV.

How similar studies have performed: Previous studies have shown promising results in vaccine responses among immunocompromised populations, but this specific approach is novel.

Eligibility criteria

* 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 this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Maura M Manion, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Maura M Manion, M.D.

Conditions Herpes Zoster; HERPES ZOSTER; Shingrix Vaccine