Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
Vaccination; Infection, Vaccine Adverse Reaction
About this trial
This is an interventional prevention trial for Vaccination; Infection focused on measuring Recombinant zoster vaccine, Vaccination of people living with HIV
Eligibility Criteria
Inclusion Criteria: 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. 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.
Sites / Locations
- Seoul National University HospitalRecruiting
- National Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
HIV #1
HIV #2
CD4+ T cell count <300 cells/µL
CD4+ T cell count≥300 cells/µL