drugset / Trial / NCT00130325
A Trial of Isoniazid for the Reversion of Interferon Gamma ELISPOT in Tuberculosis (TB) Case Contacts
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2004-10
- Primary completion
- 2008-10
- Completion
- 2009-06
Publications
- Background Hill PC, Brookes RH, Fox A, Fielding K, Jeffries DJ, Jackson-Sillah D, Lugos MD, Owiafe PK, Donkor SA, Hammond AS, Otu JK, Corrah T, Adegbola RA, McAdam KP. Large-scale evaluation of enzyme-linked immunospot assay and skin test for diagnosis of Mycobacterium tuberculosis infection against a gradient of exposure in The Gambia. Clin Infect Dis. 2004 Apr 1;38(7):966-73. doi: 10.1086/382362. Epub 2004 Mar 16.
- Adetifa IM, Ota MO, Jeffries DJ, Lugos MD, Hammond AS, Battersby NJ, Owiafe PK, Donkor SD, Antonio M, Ibanga HB, Brookes RH, Aka P, Walton R, Adegbola RA, Hill PC. Interferon-gamma ELISPOT as a biomarker of treatment efficacy in latent tuberculosis infection: a clinical trial. Am J Respir Crit Care Med. 2013 Feb 15;187(4):439-45. doi: 10.1164/rccm.201208-1352OC. Epub 2012 Dec 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Isoniazid | Small molecule | 900 mg | — |