Immune Responses to BCG Vaccination in Malawi and the UK

Phase 2

Completed

• Conditions: Immunity, Cellular; Hypersensitivity, Delayed Type

• Registration Number: NCT00241657
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2002-12
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Last Update Submitted: 2005-12-14
• Last Update Posted: 2005-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• HIV positive
• Pregnant
• Seriously ill

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Delayed-type hypersensitivity
cytokine responses (eg IFNg) to mycobacterial antigens

Secondary Outcome Measures

Name	Time	Method
scar size

Trial Locations

Locations (2)

Karonga Prevention Study; 🇲🇼 Chilumba, Karonga District, Malawi

Redbridge and Waltham Forest Primary Care Trust; 🇬🇧 Ilford, Essex, United Kingdom