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Immune Responses to BCG Vaccination in Malawi and the UK

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241657
First Posted: October 19, 2005
Last Update Posted: December 15, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
London School of Hygiene and Tropical Medicine
  Purpose
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.

Condition Intervention Phase
Immunity, Cellular Hypersensitivity, Delayed Type Biological: BCG Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Delayed-type hypersensitivity
  • cytokine responses (eg IFNg) to mycobacterial antigens

Secondary Outcome Measures:
  • scar size

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV positive
  • Pregnant
  • Seriously ill
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241657


Locations
Malawi
Karonga Prevention Study
Chilumba, Karonga District, Malawi, PO Box 36
United Kingdom
Redbridge and Waltham Forest Primary Care Trust
Ilford, Essex, United Kingdom, IG1 2QX
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Paul EM Fine, VMD, PhD London School of Hygiene and Tropical Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00241657     History of Changes
Other Study ID Numbers: KPS10
First Submitted: October 17, 2005
First Posted: October 19, 2005
Last Update Posted: December 15, 2005
Last Verified: December 2002

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Delayed
Immune System Diseases