Immune Responses to BCG Vaccination in Malawi and the UK

NCT ID: NCT00241657

Last Updated: 2005-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Immunity, Cellular Hypersensitivity, Delayed Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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BCG

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* HIV positive
* Pregnant
* Seriously ill
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Paul EM Fine, VMD, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Karonga Prevention Study

Chilumba, Karonga District, Malawi

Site Status

Redbridge and Waltham Forest Primary Care Trust

Ilford, Essex, United Kingdom

Site Status

Countries

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Malawi United Kingdom

Other Identifiers

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KPS10

Identifier Type: -

Identifier Source: org_study_id