A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •All subjects: age 18-65, prior BCG vaccine (scar)
- •56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA)
- •21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA)
排除标准
- •pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness
研究组 & 干预措施
Sterile saline
Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos
干预措施: Sterile saline (Biological)
BCG
Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos
干预措施: BCG (Biological)
DAR-901
Intradermal administration at 0, 2 and 4 months
Three dose groups in dose escalation: 0.1 mg, 0.3 mg and 1.0 mg, all constituted in 0.1 mL
干预措施: DAR-901 (Biological)
结局指标
主要结局
Safety
时间窗: 10 months
Subjects will be followed for both systemic side effects and injection site reactions
次要结局
- Immunogenicity(10 months)