Human Immune Responses Toward HIV-1 Envelope Antigens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine
研究概览
简要总结
The primary objectives of this study is to
- Define the envelope-specific B-cell and T-cell responses in humans who have received a St. Jude HIV-1 vaccine.
- Describe mechanisms of HIV-1 envelope processing and consequent B-cell and T-cell activities.
详细描述
The goal of this protocol is to understand how human lymphocytes respond to HIV-1 antigens in the context of vaccination or infection. This protocol will support understanding of the immune response by providing a source of lymphocytes and serum from selected individuals to study in laboratory based investigations. Blood samples from individuals who have received an HIV-1 vaccine, individuals who are HIV-1-infected, and individuals who are HIV-1-uninfected are requested to: (1) test previously vaccinated volunteers for HIV-1 envelope-specific B-cell and T-cell immune activities, and (2) increase understanding of how the human immune system processes and responds to HIV-1 envelope proteins.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is greater than or equal to 18 years of age.
- •Participant is in good general health.
- •Participant weighs ≥ 110 pounds.
- •Participant has hemoglobin > 12 gm/dL within last 12 weeks.
- •Group 1 (Vaccinees) only Inclusion Criteria:
- •Participant has previously received one of the St. Jude HIV-1 vaccines via enrollment in prior St. Jude HIV vaccine studies.
- •Group 2 (HIV positive) only Inclusion Criteria:
- •Participant is HIV-1 positive by medical record review.
- •Group 3 (HIV negative) only Inclusion Criteria:
- •Participant is HIV-1 negative as determined by HIV ELISA.
排除标准
- •Participant is unable or unwilling to give written informed consent.
- •Participant is pregnant female.
- •Group 2 (HIV positive) only Exclusion Criteria:
- •Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week)
结局指标
主要结局
Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine
时间窗: 5 years
The outcome measures will be assessed in such a way that individuals will be sampled longitudinally (every 6months) until the immune response is no longer detectable by HIV ELISA or until the 5 year study period is complete, whichever comes first. A volume of 120 ml will be collected at each visit for immune response assays (both B-cell and T-cell) and 2 ml of blood will be collected for the HIV ELISA.
次要结局
- Mechanism of HIV-1 envelope processing B cell and T cell activities(5 years)