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

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.

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 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.

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.