Bacillus Calmette-Guerin (BCG) Vaccine and Morbidity From Malaria
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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 |
- Incidence of clinical malaria.
- 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 |
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| Guinea-Bissau | |
| Bandim Health Project | |
| Bissau, Guinea-Bissau, 1004 Bissau CODEX | |
| 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 BCG Vaccine |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013