NCT00130325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

Enrollment Period

4 years

First QC Date

August 11, 2005

Last Update Submit

January 12, 2010

Conditions

Tuberculosis

Keywords

ELISPOT,tuberculosis,Mycobacterium tuberculosisIsoniazidClinical trial

Outcome Measures

Primary Outcomes (2)

  • Qualitative IFN-g ELISPOT reversion

    12 months

  • Quantitative IFN-g ELISPOT reversion

    12 months

Study Arms (2)

A

ACTIVE COMPARATOR

Isoniazid arm

Drug: Isoniazid

B

PLACEBO COMPARATOR

Placebo of Isoniazid tablet 300mg

Drug: Placebo of Isoniazid tablets 300mg

Interventions

IsoniazidDRUG

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

A
Placebo of Isoniazid tablets 300mgDRUG

Isoniazid BP 0mg twice weekly for 6 months

B

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC Laboratories

Banjul, KSMD, Po Box 273 Banjul, The Gambia

Location

Related Publications (2)

  • 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.

    PMID: 15034828BACKGROUND

  • 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.

    PMID: 23220919DERIVED

Related Links

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Philip C Hill, MPH FRACP

    MRC Laboratories, Gambia

    PRINCIPAL INVESTIGATOR

  • Roger H Brookes, PhD

    MRC laboratories, Gambia

    PRINCIPAL INVESTIGATOR

  • Richard A Adegbola, PhD FRCPath

    MRC laboratories, Gambia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2008

Study Completion

June 1, 2009

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

TH(1)