Bacillus Calmette-Guerin (BCG) Vaccine and Morbidity From Malaria
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.
|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|
- Incidence of clinical malaria.
- Prevalence of malaria parasitemia.
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2003|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131794
|Bandim Health Project|
|Bissau, Guinea-Bissau, 1004 Bissau CODEX|
|Principal Investigator:||Amabelia Rodrigues, PhD||Bandim Health Centre, Bissau.|