Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV

2304-110-1426

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.

2023-06-27

2026-03-31

2026-03-31

Recruiting

Early phase I

150

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-02-12