Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV (NCT05898464) | Clinical Trial Compass
CompletedPhase 4
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
South Korea71 participantsStarted 2023-06-27
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 med…