Phase III Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,802
- 主要终点
- Number of study population III Negative for Reaction at 24 hours After intradermal injection with EC or TB-PPD
研究概览
简要总结
The investigators recruit about 1800 cases participants who has signed ICF,then do some physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific gamma-interferon detection ,collection of medical history and the like .These subjects who meet the standard are considered as study population I. Population I are injected intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at different arm of the same subject and get at least 360 participants whose three kinds of detection result are all negative and are considered as study population II.Then,they are immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG.Do specific gamma-interferon detection before the skin test,then inject intradermally with ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.
详细描述
The investigators recruit about 1800 cases participants who has signed ICF,then do some physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific gamma-interferon detection(γ-IFN) ,collection of medical history and the like .These subjects who meet the standard are considered as study population I. Population I are injected intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at different arm of the same subject and get at least 360 participants whose three kinds of detection result are all negative(specific gamma-interferon detection ,TB-PPD and ESAT6-CFP10 ) and are considered as study population II.Then,they are immune to the Bacillus Calmette -Guerin(BCG) vaccine or the placebo of the BCG(BCG and the palcebo ratio of 2:1 ),they are incorporated into the Population III. Do specific gamma-interferon detection before the skin test,then inject intradermally with ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity. Evaluate the specificity of the ESAT6-CFP10 allergen by negative coincidence rate for BCG vaccinated crowd ,and the safety of ESAT6-CFP10 in all participant,and the correlation between ESAT6-CFP10 ,TB-PPD and γ-IFN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of the screening crowd
- •18-65 years old;
- •consent and signed informed consent form;
- •comply with follow-up;
- •No history of tuberculosis;
- •Physical condition:no obvious heart,liver,kidney, digestive tract,nervous system,mental disorder from signed informed consent to the injection;
- •Normal axillary temperature (quiet condition blow 37.0℃)
- •No abnormal chest by X-ray check;
排除标准
- •of the screening crowd
- •Has the following serious disease, such as advanced cancer, diabetes, chronic obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc;
- •Epilepsy and psychiatric patients
- •Has known or suspected (or risk possible) immune damaged or abnormal functional , accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside the gastrointestinal tract protein or blood products or plasma extraction in 3 months；
- •Has acute febrile diseases and infectious diseases;
- •taking part in any other new drug clinical trials or participated in any other new drug clinical trials within 3 months before this trials;
- •a clear history of drug allergy ；
- •In pregnancy or lactation；
- •There is a clear history of high blood pressure and systolic blood pressure ≥180mmHg , and/or diastolic blood pressure of ≥ 100mmHg after drug control ；
- •Researchers consider that any conditions may affect the trial evaluation.
- •Inclusion Criteria of three negative crowd
- •conforming to the inclusion criteria of the screening crowd ;
- •the result of four detection methods are all the negative: ESAT6-CFP10 、 TB - PPD and specific gamma - IFN and HIV;
- •Exclusion Criteria of three negative crowd
- •conforming to the exclusion criteria of the screening crowd ;
- •With BCG vaccination taboo .
研究组 & 干预措施
ESAT6-CFP10 in the right arm
Each volunteer is intradermally injected two agents in different arms 12 weeks after Bacillus Calmette - Guerin (BCG) or placebo of BCG immunization :ESAT6-CFP10 in the right arm and TB-PPD in the left arm concomitantly,according to a randomisation scheme.
干预措施: Bacillus Calmette - Guerin (Biological)
ESAT6-CFP10 in the right arm
Each volunteer is intradermally injected two agents in different arms 12 weeks after Bacillus Calmette - Guerin (BCG) or placebo of BCG immunization :ESAT6-CFP10 in the right arm and TB-PPD in the left arm concomitantly,according to a randomisation scheme.
干预措施: placebo of Bacillus Calmette - Guerin (Biological)
ESAT6-CFP10 in the left arm
Each volunteer is intradermally injected two agents in different arms 12 weeks after Bacillus Calmette - Guerin (BCG) or placebo of Bacillus Calmette - Guerin immunization :ESAT6-CFP10 in the left arm and TB-PPD in the right arm concomitantly,according to a randomisation scheme.
干预措施: Bacillus Calmette - Guerin (Biological)
ESAT6-CFP10 in the left arm
Each volunteer is intradermally injected two agents in different arms 12 weeks after Bacillus Calmette - Guerin (BCG) or placebo of Bacillus Calmette - Guerin immunization :ESAT6-CFP10 in the left arm and TB-PPD in the right arm concomitantly,according to a randomisation scheme.
干预措施: placebo of Bacillus Calmette - Guerin (Biological)
结局指标
主要结局
Number of study population III Negative for Reaction at 24 hours After intradermal injection with EC or TB-PPD
时间窗: At 24 hours after Intradermal injection with EC or TB-PPD
Number of study population III Negative for Reaction at 48 hours After intradermal injection with EC or TB-PPD
时间窗: At 48 hours after Intradermal injection with EC or TB-PPD
次要结局
- the number of participants with Adverse Events after Intradermal injection(within 48 hours after after Intradermal injection)