Back to resultsImmune Responses to BCG Vaccination in Malawi and the UK
Primary Purpose
Immunity, Cellular, Hypersensitivity, Delayed Type
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BCG
Sponsored by
About this trial
This is an interventional prevention trial for Immunity, Cellular
Eligibility Criteria
Inclusion Criteria: BCG unvaccinated HIV negative Not pregnant Informed Consent Exclusion Criteria: HIV positive Pregnant Seriously ill
Sites / Locations
- Karonga Prevention Study
- Redbridge and Waltham Forest Primary Care Trust
Outcomes
Primary Outcome Measures
Delayed-type hypersensitivity
cytokine responses (eg IFNg) to mycobacterial antigens
Secondary Outcome Measures
scar size
Full Information
NCT ID
NCT00241657
First Posted
October 17, 2005
Last Updated
December 14, 2005
Sponsor
London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00241657
Brief Title
Immune Responses to BCG Vaccination in Malawi and the UK
Study Type
Interventional
2. Study Status
Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity, Cellular, Hypersensitivity, Delayed Type
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
BCG
Primary Outcome Measure Information:
Title
Delayed-type hypersensitivity
Title
cytokine responses (eg IFNg) to mycobacterial antigens
Secondary Outcome Measure Information:
Title
scar size
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BCG unvaccinated
HIV negative
Not pregnant
Informed Consent
Exclusion Criteria:
HIV positive
Pregnant
Seriously ill
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul EM Fine, VMD, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karonga Prevention Study
City
Chilumba
State/Province
Karonga District
ZIP/Postal Code
PO Box 36
Country
Malawi
Facility Name
Redbridge and Waltham Forest Primary Care Trust
City
Ilford
State/Province
Essex
ZIP/Postal Code
IG1 2QX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Immune Responses to BCG Vaccination in Malawi and the UK
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