Status:
COMPLETED
A Trial of Isoniazid for the Reversion of Interferon Gamma ELISPOT in Tuberculosis (TB) Case Contacts
Lead Sponsor:
Medical Research Council Unit, The Gambia
Conditions:
Tuberculosis
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
There are new TB vaccines already developed that need to be tried in humans to assess their efficacy. The researchers had previously shown that production of interferon gamma by T cells in response t...
Detailed Description
Current efforts to control the spread of tuberculosis are failing. An increasingly large number of new generation vaccines are being produced and a plan for assessing their ability to prevent disease ...
Eligibility Criteria
Inclusion
- Healthy person aged 15 years and above
- Normal medical history and physical examination
- Normal biochemistry and haematological indices
- Mantoux ≥ 10mm
- Negative HIV antibody test
- No serological evidence of hepatitis B virus (HBV) infection
- Normal Chest X-ray
- ESAT6 and/or CFP-10 peptides and ESAT6/CFP-10 protein positive (≥10 SFC for ESAT 6 or CFP-10 and ESAT6/CFP-10 protein).
- Index case is sputum smear positive
- Index case has chest X ray (CXR) characteristics of TB
Exclusion
- Pregnant female
- Haemoglobin \<8 g/dl
- Previous history of tuberculosis
- Clinical case of tuberculosis
- Current participation in another clinical trial, or within 12 weeks of this study.
- Any other factor that might increase the risk of an adverse outcome from participation in the trial
- Significant history or evidence of skin disorder, allergy, immunodeficiency, organ specific disorders causing significant immunodeficiency.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00130325
Start Date
October 1 2004
End Date
June 1 2009
Last Update
January 13 2010
Active Locations (1)
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1
MRC Laboratories
Banjul, KSMD, The Gambia, Po Box 273 Banjul