Last updated: February 8, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Shingles
Chickenpox (Varicella Zoster Infection)
Rash
Treatment
Recombinant zoster vaccination
Clinical Study ID
NCT05898464
2304-110-1426
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria (for HIV #1, HIV #2) :
- 19 years old or older, HIV-1 infected person who have voluntarily agreed toparticipate in the study.
- Have been taking antiviral medications stably for at least one month at the time ofscreening.
- Have a CD4+ T-cell count measured within one month of screening.
- Do not have AIDS-defining diseases (excluding oral thrush) or acute/uncontrolledopportunistic 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
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 thefirst vaccine dose.
- Chronic administration of immunosuppressive or other immune-modifying drugs within 6months prior to ther first vaccine dose.
- Administration of immunoglobulins, and/or any blood products within 3 months precedingthe first dose of study vaccine
- Have a medical condition that makes receiving an intramuscular injection medicallycontraindicated.
- Have a disease or condition that may affect the immunogenicity or safety of thevaccine.
- Receiving any other vaccine within 14 days prior to and 14 days after receiving thestudy vaccine.
- Participate in a clinical trial that involves other investigational product or deviceduring the course of the study.
- Any other person who, in the opinion of the investigator, is unsuitable for immuneresponse assessment.
Study Design
Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Recombinant zoster vaccination
Phase: 4
Study Start date:
June 27, 2023
Estimated Completion Date:
March 31, 2026
Study Description
Connect with a study center
National Medical Center
Seoul, 04564
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
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