NCT01879163已完成1 期
A Phase I Randomised Trial to Evaluate the Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in Bacille Calmette-Guérin (BCG) Vaccinated Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety evaluation through actively and passively collected data on adverse events
研究概览
简要总结
This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.
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
- Single (Participant)
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 must meet all of the following criteria to enter the trial:
- •Healthy adult aged 18-55 years
- •Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF) and able to travel to Oxford for vaccination for the duration of the trial period
- •No relevant findings in medical history or on physical examination
- •Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
- •Allow the Investigators to discuss the individual's medical history with their GP
- •Use effective contraception for the duration of the trial period (females only)
- •Refrain from blood donation during the trial
- •Give written informed consent
- •Allow the Investigator to register subject details with a confidential database to prevent concurrent entry into clinical trials
- •Able and willing (in the Investigator's opinion) to comply with all the trial requirements
排除标准
- •Subjects must meet none of the following criteria to enter the trial:
- •Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
- •Clinical, radiological, or laboratory evidence of current active TB disease
- •Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA vaccine
- •Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), autoimmune disease, cancer (except BCC or CIS), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- •History of serious psychiatric condition
- •Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
- •History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine, including eggs
- •Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the subject in the trial
- •Positive HBsAg, HCV or HIV antibodies
- •Female currently lactating, confirmed pregnancy or intention to become pregnant during trial period
- •Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the trial vaccine for 30 days prior to dosing with the trial vaccine, or planned use during the trial period
- •Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- •Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial
研究组 & 干预措施
Group C
Active Comparator
12 subjects receiving intradermal injection of 5x10^7 pfu MVA85A (following completion of group A, subjects will be randomised to either group B or group C).
干预措施: MVA85A (Biological)
Group B
Active Comparator
12 subjects receiving intradermal injection of 5x10^7 pfu MVA85A-IMX313 (following completion of group A, subjects will be randomised to either group B or group C).
干预措施: MVA85A-IMX313 (Biological)
Group A
Experimental
The first six volunteers will receive an intradermal injection of 1x10^7 pfu MVA85A-IMX313 (non-randomised).
干预措施: MVA85A-IMX313 (Biological)
结局指标
主要结局
Safety evaluation through actively and passively collected data on adverse events
时间窗: Up to 24 weeks
To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A-IMX313 vaccination compared to MVA85A vaccination, by actively and passively collecting data on adverse events.
次要结局
- Evaluation of immune response of MVA85A-IMX313 vaccination compared with MVA85A vaccination in healthy, BCG vaccinated adults.(Up to 24 weeks)
研究者
研究点 (2)
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