A Trial of Isoniazid for the Reversion of Interferon Gamma ELISPOT in Tuberculosis (TB) Case Contacts

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 to TB antigens is a more specific marker of TB infection.

The researchers hypothesize that this can be used as a reliable early marker of TB vaccine efficacy. The researchers expect to show a significantly increased reversion of this test in household contacts of TB patients given Isoniazid prophylaxis treatment for 6 months.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical Research Council Unit, The Gambia
• Treatments: Isoniazid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.