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

This study has been completed.
Sponsor:
Collaborators:
Bandim Health Project
Hospital Nacional Simao Mendes, Bissau
Statens Serum Institut
London School of Hygiene and Tropical Medicine
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00131794
First received: August 18, 2005
Last updated: October 13, 2005
Last verified: August 2005
  Purpose

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 Intervention Phase
Malaria
Biological: BCG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: The Effect of BCG Vaccine on Morbidity From Malaria

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Incidence of clinical malaria.

Secondary Outcome Measures:
  • Prevalence of malaria parasitemia.

Estimated Enrollment: 1200
Study Start Date: January 2003
Estimated Study Completion Date: December 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131794

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

No publications provided

ClinicalTrials.gov Identifier: NCT00131794     History of Changes
Other Study ID Numbers: ITDCVG31
Study First Received: August 18, 2005
Last Updated: October 13, 2005
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Malaria
BCG vaccine
Guinea Bissau

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on October 19, 2014