NCT00282581终止1 期
A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection
详细描述
This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28.
Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product
- •Subjects must test positive for HIV infection
- •Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses.
- •Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control
- •subjects must be clinically stable for 6 months prior to study enrollment.
排除标准
- •Subjects with a known or suspected history of immunodeficiency (with the exception of HIV infection)
- •Subjects with history or prior exposure to a vaccinia-containing product
- •subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions)
- •Subjects with concomitant illnesses associated with impairment of immunologic function.
- •subjects with dementia
- •Subjects with malignancy.
- •Subjects with a known history of Cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities
- •Current or past history of eczema
- •known allergies to any component of MVA, including eggs or egg products, or allergies to blood products
- •females must not be pregnant and using approved contraceptives.
- •Morbid obesity
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: MVA Smallpox Vaccine (Biological)
结局指标
主要结局
Safety
时间窗: Study Completion
次要结局
- Immunogenicity(Study Completion)
研究者
研究点 (6)
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