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Bacillus Calmette-Guerin (BCG) Vaccine and Morbidity From Malaria

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ClinicalTrials.gov Identifier: NCT00131794
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : September 2, 2016
Bandim Health Project
Hospital Nacional Simao Mendes, Bissau
Statens Serum Institut
Information provided by:
London School of Hygiene and Tropical Medicine

Brief Summary:

BCG vaccine is given at or shortly after birth in many developing countries to prevent tuberculosis. In Guinea Bissau, it has been shown that its protective effect against death is greater than would be expected from its effect against tuberculosis. This observation suggests that BCG may enhance the ability of the immune system of young children to make a protective response to other infections, including malaria. There is some evidence to support this hypothesis as BCG protects against malaria in experimental animals.

Because BCG is a recommended vaccine, a randomised controlled trial of BCG at birth would not be ethically justifiable. However, it is not known whether re-vaccination with BCG in the second year of life might provide some added benefit and a large study to determine this is under way in Guinea Bissau. This study examined the effect of re-vaccination with BCG on the incidence of clinical malaria. If re-vaccination with BCG at 19 months of age is found to protect against malaria this would support the hypothesis that one of the ways that BCG at birth provides protection to young children is through an effect on malaria.

Condition or disease Intervention/treatment Phase
Malaria Biological: BCG Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: The Effect of BCG Vaccine on Morbidity From Malaria
Study Start Date : January 2003
Estimated Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of clinical malaria.

Secondary Outcome Measures :
  1. Prevalence of malaria parasitemia.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age more than 18 months and less than 24 months
  • Previous BCG vaccination

Exclusion Criteria:

  • Mantoux skin reaction > 14 mm
  • Chronic underlying illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131794

Bandim Health Project
Bissau, Guinea-Bissau, 1004 Bissau CODEX
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Bandim Health Project
Hospital Nacional Simao Mendes, Bissau
Statens Serum Institut
Principal Investigator: Amabelia Rodrigues, PhD Bandim Health Centre, Bissau.

ClinicalTrials.gov Identifier: NCT00131794     History of Changes
Other Study ID Numbers: ITDCVG31
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2005

Keywords provided by London School of Hygiene and Tropical Medicine:
BCG vaccine
Guinea Bissau

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic