A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Safety
研究概览
简要总结
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 a history of mild to moderate Atopic Dermatitis.
详细描述
This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will undergo a screening period, a treatment/observation period during which all subjects will receive injections on study day 0 and study day 28 of investigational vaccine or placebo. The clinical observation period will be completed at day 56. A visit will occur at approximately 3 months after the second study injection (study day 118) for additional blood collection and a review of the subject's health status. Follow-up will be obtained via telephone contacts approximately 6 months after the end of the second injection during the treatment/observation period.
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
- 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 with no previous history of smallpox vaccination
- •Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study
- •Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria
- •At the time of screening, the subject must have "mild to moderate" AD.
排除标准
- •History or evidence of prior exposure to a vaccinia or MVA- containing product
- •known or suspected history of immunodeficiency other than AD
- •Known or suspected impairment of major organ function
- •Known history or diagnosis of cardiac disease or cerebrovascular disease
- •presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns.
- •Dementia or history of seizures
- •Known allergies to MVA or any known components of the vaccine
- •transfusion of blood, organ transplantation, or treatment with any blood product
- •morbid obesity, or a BMI less than or equal to 18.5
- •history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use
- •history of major psychiatric illness except major depression not requiring medical therapy.
- •subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0
结局指标
主要结局
Safety
时间窗: Study Completion
次要结局
- Immunogenicity(Study Completion)