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

Anhui Zhifei Longcom

Status and phase: Completed; Phase 2

Conditions: Tuberculosis

Treatments: Biological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm; Biological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm; Biological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02336542

LTao-IIb-patient

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 192 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

192 participants in 2 patient groups

TB subjects

Experimental group

Description:

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.

Treatment:

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

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

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

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

non-TB subjects with lung disease

Active Comparator group

Description:

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.

Treatment:

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

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

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

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