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
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|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Effect of BCG Vaccine on Morbidity From Malaria|
|Study Start Date :||January 2003|
|Estimated Study Completion Date :||December 2003|
- Incidence of clinical malaria.
- Prevalence of malaria parasitemia.
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|
|Principal Investigator:||Amabelia Rodrigues, PhD||Bandim Health Centre, Bissau.|