A Roll-Over Observational Study for the Extended Follow-Up of the Volunteers of the ISS T-003 Trial (ISS T-003 EF-UP2020)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Anti-Tat humoral Immune responses
研究概览
简要总结
A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.
详细描述
The volunteers enrolled in the South African ISS T-003 trial (ClinicalTrials.gov NCT01513135; SANCTR: DOH-27-0211-3351) were recently enrolled in an observational study to extend the follow-up of the trial. The results of this study (ISS T-003 EF-UP, ClinicalTrials.gov NCT02712489; SANCTR: DOH-27-0615-4948) indicate the maintenance of anti-Tat Ab in a vast proposition of vaccinees.
The new roll-over observational study (ISS T-003 EF-UP2020; SANCTR: DOH-27-072022-7347) is to be conducted to further extend the follow-up of the participants of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.
To this aim volunteers of the ISS T-003 study are included in a new 6-months study, with visits at weeks 0 and 24, during which the persistence and levels of anti-Tat antibodies (primary endpoint) and the CD4+ T-cell and HIV-1 plasma viraemia levels (secondary endpoint) will be evaluated. In addition, depending on the availability of residual specimens (PBMC, serum and plasma), further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers. Clinical signs and symptoms of disease progression and AIDS-defining events will also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previous participation in the ISS T-003 EF-UP study without withdrawal of consent;
- •availability to participate in the ensuing extended follow-up study;
- •signed informed consent.
排除标准
- •The absence of any of the above criteria will exclude the participants from the study.
结局指标
主要结局
Anti-Tat humoral Immune responses
时间窗: Week 0 and week 24
Changes of anti-Tat serum antibody levels
次要结局
- CD4+ T cells levels(Week 0 and week 24)
- HIV-1 plasma viremia(Week 0 and week 24)
- HIV-1 reservoir(Week 0 and week 24)