Vaccine Adverse Reaction Clinical Trial
Official title:
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
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.
- HIV-infected individuals willing to receive recombinant zoster vaccine will be recruited at three study hospitals. - Participants are divided into two groups based on HIV status and CD4+ T cell count (HIV #1: CD4+ T cell count <300 cells/µL, HIV #2: CD4+ T cell count≥300 cells/µL, non-HIV). - Target numbers are 50 for each group. - Give 2 intramuscular doses of recombinant zoster vaccine 2 months apart. - Contact by phone on days 3 and 7 after each dose to assess for adverse events. - Evaluate immunogenicity at 1 month and 13 months after the second dose and safety. - An interim analysis is planned after the first approximately 30 participants of HIV group and 10 participants of non-HIV group complete a visit 13 months after 2nd dose. - Evaluation for the safety is planned after the first approximately 10 participants of the HIV #2 arm complete a visit 13 months after 2nd dose. ;
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