NCT05898464进行中（未招募）4 期
Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Humoral immune response
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
HIV #1
Experimental
CD4+ T cell count <300 cells/µL
干预措施: Recombinant zoster vaccination (Biological)
HIV #2
Active Comparator
CD4+ T cell count≥300 cells/µL
干预措施: Recombinant zoster vaccination (Biological)
non-HIV
Active Comparator
Healthy adult
干预措施: Recombinant zoster vaccination (Biological)
结局指标
主要结局
Humoral immune response
时间窗: 1 month, 13 months after 2nd dose
Defined as a 4-fold or greater increase in anti-VZV antibody concentration from pre-vaccination testing in seropositive subjects and a 4-fold or greater increase in anti-gE antibody concentration from the cutoff in seronegative subjects prior to vaccination.
次要结局
- Cell-mediated immunogenicity(1 month, 13 months after 2nd dose)
- Differences in humoral immune response and cell mediated immunogenecity(1 month, 13 months after 2nd dose)
- Grade 3/4 adverse events (AE)(Within 7 days (Day 0-6) after the first and second dose.)
- Any AIDS-defining disease(Within 3 months after 2nd dose)
- Increase in HIV Viral Load or decrease in CD4+ T-cell Count(1 month after 2nd dose)
- Any serious adverse events (SAEs)(Throughout the study period: Day 0~450 or termination, whichever came first)
研究者
Wan Beom Park
Professor
Seoul National University Hospital
研究点 (2)
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