NCT01371175已完成2 期
A Randomized, Placebo-Controlled, Dosage-Escalating Phase 2A Study, Double-Blinded With Respect to Assignment to Either Vaccine or Placebo, to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Administered Intramuscularly Followed by an MVA HIV-1 Vaccine Administered at Three Different Dosage Levels and by Three Different Routes to HIV-Uninfected, Healthy, Volunteers.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.
Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Clinically relevant abnormality on history or examination including history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the designated trial physician in last 6 months;
- •Presence of any chronic condition;
- •Any of the following abnormal laboratory parameters that are moderate, severe, or very severe: haematology (haemoglobin, absolute neutrophil count absolute lymphocyte count , absolute CD4 count, platelets); urinalysis, biochemistries (total bilirubin, creatinine, AST, ALT). Volunteers with mild laboratory abnormalities which are judged by the principal investigator or designee to be not clinically significant may be enrolled.
- •If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
- •Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment;
- •Receipt of blood transfusion or blood products 6 months prior to enrolment;
- •Participation in another clinical trial of an investigational product currently or within last 12 weeks or expected participation during this study;
- •History of severe local or general reaction to vaccination or history of allergic reactions;
- •History of grand-mal epilepsy, or currently taking anti-epileptics;
- •Confirmed HIV-1 or HIV-2 seropositive;
- •Positive for hepatitis B (surface antigen) or confirmed diagnosis of active syphilis at the time of enrolment (RPR positive and TPHA positive or equivalent), positive for hepatitis C antibodies;
- •Unlikely to comply with protocol. Prior receipt of smallpox vaccination should be documented, but will not be an exclusion criterion.
结局指标
主要结局
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
时间窗: 18 months
次要结局
- Immunogenicity: Proportion of volunteers with HIV-1 specific T-cell responses by ELISPOT assay.(Day 0, Month 1, Month 2, Month 5, Month 6, Month 8, Month 9, Month 12, Month 18)
研究者
研究点 (2)
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