NCT00131794

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

September 2, 2016

Status Verified

August 1, 2005

First QC Date

August 18, 2005

Last Update Submit

September 1, 2016

Conditions

Malaria

Keywords

MalariaBCG vaccineGuinea Bissau

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinical malaria.

Secondary Outcomes (1)

  • Prevalence of malaria parasitemia.

Interventions

BCGBIOLOGICAL

Eligibility Criteria

Age18 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age more than 18 months and less than 24 months
  • Previous BCG vaccination

You may not qualify if:

  • Mantoux skin reaction \> 14 mm
  • Chronic underlying illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Bissau, 1004 Bissau CODEX, Guinea-Bissau

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Amabelia Rodrigues, PhD

    Bandim Health Centre, Bissau.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

January 1, 2003

Study Completion

December 1, 2003

Last Updated

September 2, 2016

Record last verified: 2005-08

Locations

GU(1)