Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Medical Research Council Laboratories, Gambia |
---|---|
Information provided by: | Medical Research Council Laboratories, Gambia |
ClinicalTrials.gov Identifier: | NCT00130325 |
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.
Condition | Intervention |
---|---|
Tuberculosis |
Drug: Isoniazid Drug: Placebo of Isoniazid tablets 300mg |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind Placebo-Controlled Randomized Trial of Isoniazid for the Reversion of a Positive IFNg ELISPOT in TB Case Contacts |
Estimated Enrollment: | 300 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Isoniazid arm
|
Drug: Isoniazid
Drug: Isoniazid
INH 900mg twice weekly for 6 months
|
B: Placebo Comparator
Placebo of Isoniazid tablet 300mg
|
Drug: Placebo of Isoniazid tablets 300mg
Isoniazid BP 0mg twice weekly for 6 months
|
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 and treat infection needs to be developed.
The MRC Labs in The Gambia is well positioned to conduct safety and immunogenicity studies and also to conduct trials of the therapeutic effect of these vaccines in preventing disease in case contacts who are infected.
This study is part one of a three-step plan to develop a reliable early surrogate marker of the therapeutic efficacy of new TB vaccines.
The three-step plan is as follows:
For this first step the researchers will test the following hypothesis:
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Philip C Hill, MPH, FRACP | +220 4495442-5 ext 491 | phill@mrc.gm |
Contact: Ifedayo MO Adetifa, MB;BS, FWACP | +220 4495442-5 ext 441 | iadetifa@mrc.gm |
Gambia, KSMD | |
MRC Laboratories | Recruiting |
Banjul, KSMD, Gambia, Po Box 273 Banjul | |
Contact: Ifedayo MO Adetifa, MB;BS, FWACP +4495442-5 ext 441 iadetifa@mrc.gm | |
Contact: Philip C Hill, MPH, FRACP +4495442-5 ext 491 phill@mrc.gm | |
Principal Investigator: Philip C Hill, MPH FRACP | |
Principal Investigator: Roger H Brookes, Ph.D |
Principal Investigator: | Philip C Hill, MPH FRACP | MRC Laboratories, Gambia |
Principal Investigator: | Roger H Brookes, PhD | MRC laboratories, Gambia |
Study Chair: | Richard A Adegbola, PhD FRCPath | MRC laboratories, Gambia |
Study ID Numbers: | IRS SCC965 |
Study First Received: | August 11, 2005 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00130325 |
Health Authority: | Gambia: Department of State for Health and Social Welfare |
ELISPOT, tuberculosis, Mycobacterium tuberculosis Isoniazid Clinical trial |
Bacterial Infections Gram-Positive Bacterial Infections Interferon Type II Interferons |
Mycobacterium Infections Tuberculosis Isoniazid Interferon-gamma, Recombinant |
Antimetabolites Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Antitubercular Agents Pharmacologic Actions Fatty Acid Synthesis Inhibitors Actinomycetales Infections |