Phase II, Double-blind, Randomised, Dose-finding Study to Evaluate the Immunogenicity of Three Different Doses of MVA-BN Smallpox Vaccine in 18-30 Year Old Smallpox naïve Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- ELISA seroconversion rate
研究概览
简要总结
The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, aged 18 - 30 years
- •Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.
- •Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.
- •Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.
排除标准
- •Known or suspected history of smallpox vaccination or typical vaccinia scar.
- •Positive test result in MVA specific ELISA or PRNT at screening.
- •Positive result in HIV or HCV antibody test at screening.
- •HbsAG positive at screening.
- •Pregnancy or breast-feeding.
- •Uncontrolled serious infection i.e. not responding to antimicrobial therapy
- •History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.
- •History of autoimmune disease
- •History of malignancy.
- •History of chronic alcohol abuse and/or intravenous drug abuse.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of anaphylaxis or severe allergic reaction.
- •Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
- •Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
- •Chronic administration of immuno-suppressants or other immune-modifying drugs.
- •Administration or planned administration of immunoglobulins and/or any blood products during the study period.
- •Use of any investigational or non-registered drug or vaccine.
研究组 & 干预措施
Group 1
healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous
干预措施: IMVAMUNE (MVA-BN) (Biological)
Group 2
healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous
干预措施: IMVAMUNE (MVA-BN) (Biological)
Group 3
healthy, vaccinia naïve subjects
1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous
干预措施: IMVAMUNE (MVA-BN) (Biological)
结局指标
主要结局
ELISA seroconversion rate
时间窗: Day 42
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
次要结局
- PRNT seroconversion rate(Days 28, 42, 84)
- Cytotoxic T-Lymphocyte response(Days 28, 42, 84)
- Unsolicited Non-serious Adverse Events(within 31 days after any vaccination)
- Serious Adverse Events(within 12 weeks)
- Solicited Local Adverse Events(within 8 days after any vaccination)
- Solicited General Adverse Events(within 8 days after any vaccination)
- ELISA seroconversion rate(Days 28, 84)
- ELISA GMT(Days 28, 42, 84)
- PRNT GMT(Days 28, 42, 84)