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

NCT00130325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2010-01-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Isoniazid

Isoniazid 900mg, tablets, twice a week for 6 months

DRUG

Isoniazid

INH 900mg twice weekly for 6 months

DRUG

Placebo of Isoniazid tablets 300mg

Isoniazid BP 0mg twice weekly for 6 months

Sponsors & Collaborators

  • Medical Research Council Unit, The Gambia

    lead OTHER

Principal Investigators

  • Philip C Hill, MPH FRACP · MRC Laboratories, Gambia

  • Roger H Brookes, PhD · MRC laboratories, Gambia

  • Richard A Adegbola, PhD FRCPath · MRC laboratories, Gambia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2008-10-31
Completion
2009-06-30

Countries

  • The Gambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130325 on ClinicalTrials.gov