NCT01829490已完成1 期
Phase I Trial to Evaluate the Safety and Immunogenicity of a ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy BCG Vaccinated Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults.
研究概览
简要总结
This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy 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
- 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 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 vaccinations 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
- •Shared a residence within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture- or smear-positive pulmonary tuberculosis
- •Previous vaccination with any recombinant MVA, FP or adenoviral vector
- •Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular 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 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
结局指标
主要结局
Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults.
时间窗: Six months following vaccination
To evaluate the safety in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, with and without MVA85A boost vaccination, by actively and passively collecting data on adverse events.
次要结局
- To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost vaccination.(Six months following vaccination)
研究者
研究点 (4)
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