NCT00316589已完成2 期
A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 72
- 主要终点
- Serious Adverse Events
研究概览
简要总结
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects tested positive for HIV-1 infection (HIV-infected subjects).
- •Subjects that are tested negative for HIV (Healthy subjects).
- •Either on stable antiretroviral therapy or not on antiretroviral therapy.
- •CD4 cells > = 200 - 750/µl.
- •Subjects must be in good general health except for HIV infection.
- •Women must not be pregnant and use an acceptable method of contraception.
排除标准
- •Impairment of immunologic function (other than HIV infection).
- •History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
- •Uncontrolled serious infection.
- •History of or active autoimmune disease.
- •History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- •History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
- •High risk of developing a myocardial infarction or coronary death.
- •History of intravenous drug abuse (within the last 12 months).
- •Known allergy to egg or aminoglycoside (gentamicin).
- •History of anaphylaxis or severe allergic reaction.
- •Subjects undergoing treatment for tuberculosis infection or disease.
- •Chronic administration of systemic immuno-suppressants.
研究组 & 干预措施
Healthy subjects
Experimental
Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
干预措施: IMVAMUNE (MVA-BN) (Biological)
HIV-infected, vaccinia-naive
Experimental
Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
干预措施: IMVAMUNE (MVA-BN) (Biological)
HIV-infected, vaccinia-experienced
Experimental
Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
干预措施: IMVAMUNE (MVA-BN) (Biological)
结局指标
主要结局
Serious Adverse Events
时间窗: within 32 weeks
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
次要结局
- Viral Load(within 32 weeks)
- CD8+ T-cell Counts(within 32 weeks)
- Unsolicited Adverse Events: Incidence(within 29 days after any vaccination)
- Unsolicited Adverse Events: Intensity(within 29 days after any vaccination)
- Unsolicited Adverse Events: Relationship to Vaccination(within 29 days after any vaccination)
- CD4+ T-cell Counts(within 32 weeks)
- Related Grade >=3 Adverse Events(within 29 days after any vaccination)
- Solicited Local Adverse Events(within 8 days after any vaccination)
- Solicited General Adverse Events(within 8 days after any vaccination)
- PRNT Seroconversion Rate(within 32 weeks)
- PRNT GMT(within 32 weeks)
- ELISA Seroconversion Rate(within 32 weeks)
- ELISA GMT(within 32 weeks)
- ELISPOT IFN-γ: Response Rate(within 32 weeks)
- ELISPOT IFN-γ: SFU(within 32 weeks)
研究者
研究点 (72)
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