Immune Responses to BCG Vaccination in Malawi and the UK

This study has been completed.
Sponsor:
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00241657
First received: October 17, 2005
Last updated: December 14, 2005
Last verified: December 2002
  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 Blind
Primary Purpose: Prevention

Resource links provided by NLM:


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

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00241657     History of Changes
Other Study ID Numbers: KPS10
Study First Received: October 17, 2005
Last Updated: December 14, 2005
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014