Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase IIb Clinical Research

Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Wuhan Institute for Tuberculosis Control, Proswell Medical Corporation, Air Force Military Medical University, China

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.

Firstly,96 TB(Tuberculosis ) subjects which meet the standard respectively are divided into different groups through a randomized, blind methods. ESAT6-CFP10 （5μg/ml）in left arm； ESAT6-CFP10 （5μg/ml）in right arm； ESAT6-CFP10 （10μg/ml）in left arm； 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 .

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.

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 and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.

TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.

TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

the diameter of induraton or redness within 72 hours after intradermal injection with ESAT6-CFP10 in TB patients

the proportion of positive reaction within 72 hours after administered intradermally TB-PPD in TB patient

Immune response of of ESAT6-CFP10 from the size of induration OR redness in non-TB patients with lung diseases

The proportion of positive reaction after receiving specificity γ-IFN test in TB subjects and non-TB subjects with lung disease

the proportion of positive reaction within 72 hours after intradermal injection with TB-PPD in non-TB patients with lung diseases

the occurrence of adverse events within 72 hours after injection in TB subjects and non-TB subjects with lung disease

Inclusion Criteria of TB (tuberculosis ) subjects: Diagnosis TB ; 18 to 65 years ; Consent and signed informed consent forms(ICF) ; Comply with follow-up . Exclusion Criteria of TB (tuberculosis ) subjects: advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ; Taking part in other clinical or within 3 months involved in any other clinical; histories of allergy ; in pregnancy or lactation; In a mental illness ; Any conditions affect the trial evaluation. Inclusion Criteria of Non-tuberculosis subjects with lung disease : Diagnosis non-tuberculosis subjects with lung disease ; 18 to 65 years ; Consent and signed signed informed consent forms(ICF) ; Comply with follow-up . Exclusion Criteria of Non-tuberculosis subjects with lung disease : advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc ; Taking part in other clinical or within 3 months involved in any other clinical; histories of allergy; in pregnancy or lactation; In a mental illness ; Any conditions may affect the trial evaluation.

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