NCT05898464CompletedPhase 4
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to compare the immunogenicity and safety of recombinant zoster vaccine according to CD4+ T-cell count and age in people living with HIV, and to provide evidence to guide immunization of people living with HIV.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 30 May 2023
- Start date
- 27 Jun 2023
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Seoul National University Hospital
- Diseases
- HIV
- NCT number
- NCT05898464
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 71
- From 27 Jun 2023 to the primary completion date, 10 Feb 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received any type of zoster vaccine within 1 year.
- 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.
- 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.
Other illness
- Have a history of severe allergy to any of the components of Shingrix vaccine.
- Have a acute medical condition at the time of screening.
- Have a disease or condition that may affect the immunogenicity or safety of the vaccine.
Other
- Have been diagnosed with chickenpox or shingles within 12 months.
- Unable to be evaluated for adverse events via telephone contact after vaccination.
- Pregnant (including those planning to become pregnant) or lactating women.
- Any other person who, in the opinion of the investigator, is unsuitable for immune response assessment.
Who the study is looking for
- 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 before enrollment.
- 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.
- 50 years old or older who have voluntarily agreed to participate in the study.
- Do not have uncontrolled chronic medical conditions
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
- Impact of CD4 T cell counts on the immunogenicity and safety of the recombinant zoster vaccine in people living with HIV.Int J Infect Dis · 2026 · PMID 42710800
This page is information, not medical advice. Discuss any trial with your doctor.