Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 42
- 主要终点
- Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
研究概览
简要总结
The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.
No vaccine will be administered during the study period. Vaccines were administered during the primary studies.
详细描述
General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must satisfy ALL the following criteria at study entry:
- •HIV-infected subject.
- •Previous participation in a study evaluating GSK HIV vaccine
- •Written informed consent obtained from the subject.
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Subjects who did not receive a complete vaccination course in previous studies.
研究组 & 干预措施
Group A
Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
干预措施: Blood collection (Procedure)
Group A
Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
干预措施: GSK HIV vaccine 732462 (Biological)
Group B
Subjects who were administered placebo in primary studies and who accepted to participate in this study
干预措施: Blood collection (Procedure)
结局指标
主要结局
Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
CD4 count
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Viral load (VL) and method of measurement
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of HIV disease progression
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study)
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of each separate defining condition for HIV-disease progression
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of specific clinical events and death
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of potential immune-mediated diseases (pIMDs)
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of SAEs related to study participation
时间窗: Once a year after Visit 1 (during a maximum of 4 years)
次要结局
- Time between dose 1 and ART (re)-initiation or ART modification(Once a year after Visit 1 (during a maximum of 4 years))
- Time between dose 1 and CD4 count measurement(Once a year after Visit 1 (during a maximum of 4 years))
- Time between dose 1 and VL measurement(Once a year after Visit 1 (during a maximum of 4 years))
- Time between dose 1 and occurrence of HIV disease progression(Once a year after Visit 1 (during a maximum of 4 years))
- Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression(Once a year after Visit 1 (during a maximum of 4 years))
- Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)(Once a year after Visit 1 (during a maximum of 4 years))
- Antibody concentrations to vaccine antigens(Once a year after Visit 1 (during a maximum of 4 years))
- Cell-mediated immunity responses(Once a year after Visit 1 (during a maximum of 4 years))