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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jun 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a vaccine called the recombinant zoster vaccine in people living with HIV. The goal is to understand how well the vaccine works based on the participant's age and their immune system's health, indicated by a special blood cell count called CD4+ T-cell count. By gathering this information, researchers hope to provide better guidance on vaccinations for individuals living with HIV.

To be eligible for this trial, participants must be at least 19 years old and have a confirmed HIV infection, and they need to be taking antiviral medications consistently for at least a month. They also need to have a recent CD4+ T-cell count and not have any severe health conditions that could interfere with the study. Participants can expect to receive the vaccine and will be monitored for any side effects through phone calls after vaccination. It’s important to note that individuals who have recently received other vaccines, have specific medical conditions, or are pregnant cannot join the study. This trial aims to help improve vaccination practices for those living with HIV.

Gender

ALL

Eligibility criteria

• 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.