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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TB subjects

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.

Group Type EXPERIMENTAL

5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

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.

5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

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.

10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

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.

10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

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.

non-TB subjects with lung disease

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.

Group Type ACTIVE_COMPARATOR

5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

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.

5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

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.

10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

Intervention Type BIOLOGICAL

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.

10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

Intervention Type BIOLOGICAL

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.

Interventions

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5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right 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.

Intervention Type BIOLOGICAL

5μg/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 right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

Intervention Type BIOLOGICAL

10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right 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.

Intervention Type BIOLOGICAL

10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis TB ;
* 18 to 65 years ;
* Consent and signed informed consent forms(ICF) ;
* Comply with follow-up .

* 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

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No