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

CompletedPhase 4

Sponsor: Seoul National University Hospital

Conditions: Vaccination; Infection, Vaccine Adverse Reaction

Interventions: Recombinant zoster vaccination

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.

Locations (2)

Seoul, South Korea
Seoul, South Korea