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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Oct 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well the Shingrix vaccine works for preventing shingles in people with HIV, as well as in healthy adults aged 50 and older. Shingles is a painful rash caused by the same virus that leads to chickenpox, and the goal of the study is to see how the immune system responds to the vaccine in individuals with different health conditions. To participate, you need to be at least 18 years old and living with HIV, or at least 50 years old and healthy. You must also have a stable HIV treatment plan and meet certain health criteria.

If you join the study, you will visit the clinic at least four times over the course of a year. At the first visit, you will receive the Shingrix vaccine as a shot in your arm, followed by a second dose two months later. You’ll also keep track of any symptoms you experience for 28 days after each shot and may have phone calls to discuss any side effects. The study includes simple health check-ups, like blood and urine tests. This research is important to help understand how to better protect people with HIV from shingles and improve their health outcomes.

Gender

ALL

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).
• • Viral load \< 100 copies/mL at screening and documented suppression \< 40 copies/mL within 6 months of 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 one year 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.