Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
- Conditions
- Tuberculosis
- Interventions
- Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armBiological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left armBiological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armBiological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm
- Registration Number
- NCT02336542
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Brief Summary
96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.
- Detailed Description
Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods.
1. ESAT6-CFP10 （5μg/ml）in left arm；
2. ESAT6-CFP10 （5μg/ml）in right arm；
3. ESAT6-CFP10 （10μg/ml）in left arm；
4. ESAT6-CFP10 （10μg/ml）in right arm； Inject intradermally ESAT6-CFP10 and TB-PPD(tuberculin purified protein derivative ) in different arms of the same subject.For each of the participants in this clinical research, this study uniform that left arm inject a drug(ESAT6-CFP10 or TB - PPD) first, observe 30 min and no no obvious adverse reaction ,then another drug(ESAT6-CFP10 or TB - PPD) inject in right arm. We need draw blood to detect specific γ- IFN before the injection.Observe and record the vital signs (breathing, heart rate, blood pressure and temperature),the skin reaction diameter of injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.
Secondly, 96 non-TB subjects with lung disease are divided into different groups and the procedure are as the same as 96 TB subjects above .
Finally,we evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the TB patients and non-tuberculosis patients with lung diseases,determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis,and further evaluate the safety of ESAT6-CFP10 for the clinical auxiliary diagnosis of tuberculosis .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TB subjects 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm 96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. non-TB subjects with lung disease 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm 96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. TB subjects 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm 96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. TB subjects 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm 96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. non-TB subjects with lung disease 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm 96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. TB subjects 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm 96 TB subjects are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. non-TB subjects with lung disease 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm 96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm. non-TB subjects with lung disease 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm 96 non-TB subjects with lung disease are divided into four groups average .24 TB subjects are injected 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm,24 TB subjects are injected 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm.
- Primary Outcome Measures
Name Time Method the diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients within 72h after injection we measure the size 15min,24h,48h,72h after administered intradermally ESAT6-CFP10
the proportion of positive reaction within 72 hours after intradermal injection with TB-PPD in non-TB patients with lung diseases within 72h after injection we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient within 72h after injection we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
Immune response of of ESAT6-CFP10 from the size of induration OR redness in non-TB patients with lung diseases within 72h after injection we measure the size at 15min,24h,48h,72h after administered intradermally TB-PPD
The proportion of positive reaction after receiving specificity γ-IFN test in TB subjects and non-TB subjects with lung disease before administered intradermally
- Secondary Outcome Measures
Name Time Method the consistency between ESAT6-CFP10 and TB-PPD in TB subjects and non-TB subjects with lung disease within 72h after injection the consistency between ESAT6-CFP10 and γ-IFN in TB subjects and non-TB subjects with lung disease within 72h after injection the occurrence of adverse events within 72 hours after injection in TB subjects and non-TB subjects with lung disease within 72h after injection two drugs the consistency between TB-PPD and γ-IFN in TB subjects and non-TB subjects with lung disease within 72h after injection