We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131794
First Posted: August 19, 2005
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bandim Health Project
Hospital Nacional Simao Mendes, Bissau
Statens Serum Institut
Information provided by:
London School of Hygiene and Tropical Medicine
  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
Intervention Model: Single Group Assignment
Masking: Single
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 London School of Hygiene and Tropical Medicine:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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
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


Locations
Guinea-Bissau
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
Investigators
Principal Investigator: Amabelia Rodrigues, PhD Bandim Health Centre, Bissau.
  More Information

ClinicalTrials.gov Identifier: NCT00131794     History of Changes
Other Study ID Numbers: ITDCVG31
First Submitted: August 18, 2005
First Posted: August 19, 2005
Last Update Posted: September 2, 2016
Last Verified: August 2005

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

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