Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130325
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2005-08-11
Brief Title:
A Trial of Isoniazid for the Reversion of Interferon Gamma ELISPOT in Tuberculosis TB Case Contacts
Sponsor:
Medical Research Council Unit The Gambia
Organization:
Medical Research Council Unit The Gambia
Study Overview
Official Title:
A Double Blind Placebo-controlled Randomized Trial of Isoniazid for the Reversion of a Positive IFNg ELISPOT in TB Case Contacts
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRS
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 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
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
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 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
Evaluate the ability of isoniazid known to be effective in the treatment of MTB infection to revert the antigen-specific IFNg-ELISPOT in ESAT-6 andor CFP-10 positive contacts of TB patients
Compare the ability of different combinations of a TB vaccine and isoniazid to revert the ELISPOT in a 4-arm randomised trial using1 isoniazid alone 2 a TB vaccine alone 3 a combination of isoniazid and TB vaccine and 4 placebo
Compare in a randomized trial the ability of TB vaccine or vaccine plus isoniazid versus isoniazid alone to prevent the development of secondary disease
For this first step the researchers will test the following hypothesis
Those receiving isoniazid have a significantly higher reversion rate of MTB-specific responses as measured with IFNg-ELISPOT assays compared to those who receive a placebo
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
Evaluate the ability of isoniazid known to be effective in the treatment of MTB infection to revert the antigen-specific IFNg-ELISPOT in ESAT-6 andor CFP-10 positive contacts of TB patients
Compare the ability of different combinations of a TB vaccine and isoniazid to revert the ELISPOT in a 4-arm randomised trial using1 isoniazid alone 2 a TB vaccine alone 3 a combination of isoniazid and TB vaccine and 4 placebo
Compare in a randomized trial the ability of TB vaccine or vaccine plus isoniazid versus isoniazid alone to prevent the development of secondary disease
For this first step the researchers will test the following hypothesis
Those receiving isoniazid have a significantly higher reversion rate of MTB-specific responses as measured with IFNg-ELISPOT assays compared to those who receive a placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None