NCT00241657

Brief Summary

BCG vaccination has been found to provide greater protection against TB in the UK than in Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and young adults in Malawi and in the UK.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
Last Updated

December 15, 2005

Status Verified

December 1, 2002

First QC Date

October 17, 2005

Last Update Submit

December 14, 2005

Conditions

Outcome Measures

Primary Outcomes (2)

  • Delayed-type hypersensitivity

  • cytokine responses (eg IFNg) to mycobacterial antigens

Secondary Outcomes (1)

  • scar size

Interventions

BCGBIOLOGICAL

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • BCG unvaccinated
  • HIV negative
  • Not pregnant
  • Informed Consent

You may not qualify if:

  • HIV positive
  • Pregnant
  • Seriously ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karonga Prevention Study

Chilumba, Karonga District, PO Box 36, Malawi

Location

Redbridge and Waltham Forest Primary Care Trust

Ilford, Essex, IG1 2QX, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Paul EM Fine, VMD, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 19, 2005

Last Updated

December 15, 2005

Record last verified: 2002-12

Locations