A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
研究概览
简要总结
The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.
详细描述
This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 positive
- •CD4+ T Cell count >200
- •Undetectable HIV viral load for 6 months prior to screening
- •On antiretroviral treatment for 12 months prior to screening
排除标准
- •Hepatitis C positive
- •Detectable HIV viral load within 6 months prior to study entry
- •Females who are pregnant or nursing
结局指标
主要结局
Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
时间窗: After vaccination
Number of participants with grade 3 or 4 adverse events related to vaccination
Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef
时间窗: Baseline and 14 weeks
Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.
次要结局
- T Cell Proliferation(Baseline to week 14)
- IL2 and IFN Gamma Production(Baseline to week 14)
研究者
Rajesh T. Gandhi, MD
Director of Education
Massachusetts General Hospital