Comparing the safety and immune response of a zoster vaccine in people living with HIV
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
This study is testing if a new shingles vaccine is safe and effective for people living with HIV, based on their age and immune health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05898464 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the immunogenicity and safety of the recombinant zoster vaccine in individuals living with HIV, categorized by their CD4+ T-cell count and age. Participants will receive two doses of the vaccine, spaced two months apart, and will be monitored for adverse events shortly after each dose. The study will assess immune response at one month and thirteen months post-vaccination, with an interim analysis planned after a subset of participants completes their follow-up. The goal is to provide evidence to guide vaccination strategies for people living with HIV.
Who should consider this trial
Good fit: Ideal candidates include HIV-infected individuals aged 19 and older with stable antiviral treatment and specific CD4+ T-cell counts, as well as non-HIV individuals aged 50 and older.
Not a fit: Patients who have received any zoster vaccine within the past year or have a history of severe allergies to vaccine components may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies for people living with HIV, potentially reducing the incidence of shingles and its complications.
How similar studies have performed: While this approach is focused on a specific population, similar studies have shown promise in evaluating vaccine responses in immunocompromised individuals.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (for HIV #1, HIV #2) : * 19 years old or older, HIV-1 infected person who have voluntarily agreed to participate in the study. * Have been taking antiviral medications stably for at least one month at the time of screening. * Have a CD4+ T-cell count measured within one month of screening. * Do not have AIDS-defining diseases (excluding oral thrush) or acute/uncontrolled opportunistic infection at the time of enrollment. * Do not have uncontrolled chronic medical conditions other than HIV infection. Inclusion Criteria (for non-HIV) : * 50 years old or older who have voluntarily agreed to participate in the study. * Do not have uncontrolled chronic medical conditions Exclusion Criteria: * Have received any type of zoster vaccine within 1 year. * Have been diagnosed with chickenpox or shingles within 12 months. * Have a history of severe allergy to any of the components of Shingrix vaccine. * Have a acute medical condition at the time of screening. * Unable to be evaluated for adverse events via telephone contact after vaccination. * Pregnant (including those planning to become pregnant) or lactating women. * Those who have received chemotherapy or radiotherapy within 6 months prior to the first vaccine dose. * Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to ther first vaccine dose. * Administration of immunoglobulins, and/or any blood products within 3 months preceding the first dose of study vaccine * Have a medical condition that makes receiving an intramuscular injection medically contraindicated. * Have a disease or condition that may affect the immunogenicity or safety of the vaccine. * Receiving any other vaccine within 14 days prior to and 14 days after receiving the study vaccine. * Participate in a clinical trial that involves other investigational product or device during the course of the study. * Any other person who, in the opinion of the investigator, is unsuitable for immune response assessment.
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- National Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Wan Beom Park, M.D., PhD. — Seoul National University Hospital
- Study coordinator: Wan Beom Park, M.D., PhD.
- Email: wbpark1@snu.ac.kr
- Phone: 82-2-2072-3596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.