Immune Responses to BCG Vaccination in Malawi and the UK

Immunity, Cellular Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241657
• Other study ID #: KPS10
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2005
• Last updated: December 14, 2005

Study information

• Verified date: December 2002
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

Inclusion Criteria:

• BCG unvaccinated

• HIV negative

• Not pregnant

• Informed Consent

Exclusion Criteria:

• HIV positive

• Pregnant

• Seriously ill

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypersensitivity
• Hypersensitivity, Delayed
• Hypersensitivity, Delayed Type
• Immunity, Cellular

Intervention

Biological:
• BCG

Locations

Country	Name	City	State
Malawi	Karonga Prevention Study	Chilumba	Karonga District
United Kingdom	Redbridge and Waltham Forest Primary Care Trust	Ilford	Essex

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Countries where clinical trial is conducted

Malawi,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed-type hypersensitivity
Primary	cytokine responses (eg IFNg) to mycobacterial antigens
Secondary	scar size