Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine

This study has been terminated.
(A cluster of deaths in the BCG-arm compared with controls)
Sponsor:
Collaborators:
International Cooperation with Developing Countries
Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland
Medical Research Council Unit, The Gambia
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00126217
First received: August 2, 2005
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality. The specific objective of the study is to examine the effect of revaccination for purified protein derivative of tuberculin (PPD) reaction, scar size, morbidity and mortality in a randomised prospective study of revaccination versus no revaccination among children 19 months of age in Guinea-Bissau. The hypothesis is that revaccination with BCG reduces childhood mortality after 19 months of age by 30%.


Condition Intervention Phase
Malaria
Biological: Bacille Calmette Guerin (BCG)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: BCG Vaccination and Childhood Morbidity and Mortality: Interventions With Possible Implications for the Immunisation Policy in Developing Countries. Revaccination of Young Children With BCG Vaccine.

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality till 5 years of age
  • Hospitalisations till 5 years of age
  • Adverse effects within 12 months after intervention

Secondary Outcome Measures:
  • Tuberculin reaction 2 months after intervention
  • Scar reaction 2 months after intervention
  • Malaria morbidity/parasitaemia within 12 months after intervention
  • Assessment of antibody and cellular immune responses 18 months after intervention

Enrollment: 2871
Study Start Date: July 2002
Study Completion Date: September 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Bacille Calmette Guerin (BCG)
0,1 ml, revaccination at 19 months of age
No Intervention: 2

Detailed Description:

Examine in a randomised trial whether revaccination with BCG reduces childhood mortality after 19 months of age by 30%.

Criteria for verification: 3,000 children aged 1½ year enrolled and followed for an average of 3 years; information on potential adverse events among children with a positive PPD reaction; assessment of parasitaemia after revaccination; assessment of the tuberculin response and scar-formation after revaccination; and assessment of all-cause mortality during the period of follow-up.

Following consent to participate, children will be assessed for BCG scar and tuberculin reaction at 18-19 months of age. Subsequently, the children will be invited to a clinical examination at one of the health centres. The study will be explained again to the mother, and if she accepts to participate, she will draw a randomisation number deciding whether the child will be revaccinated or not. The BCG vaccine given will be the standard dose of 0.1 ml as recommended by WHO in this age group. In the beginning of the study, a group of 800 revaccinated and not revaccinated children will be followed weekly for two months to monitor morbidity and possible adverse effects of the vaccination. It is not expected that Koch like reactions will be common in this age group. However, should there be too many adverse reactions among children with a positive tuberculin test, only tuberculin negative children will be included in the continuation of the trial.

Two months after inclusion, the children will have another tuberculin test to examine changes in tuberculin reaction. At the same time, scar-size will be measured. In the initial phase of the project, a finger-prick blood sample will be collected from 1000 children to examine whether BCG boosting/no boosting have had an effect on the prevalence of malaria parasitaemia and the level of measles antibodies. Children with malaria will be treated and children with non-protective levels of measles antibodies will be offered revaccination with measles vaccine. In a group of children, samples will be collected both before and after BCG revaccination/no revaccination to measure changes in cytokine profile. Children with a large PPD reaction (> 15mm) will be followed in a similar way as the other children as this may reflect immune stimulation from exposure to natural TB. The studies of morbidity and immunological changes will be done both in the dry and the rainy seasons. The children will be followed for hospitalisations and mortality to 5 years of age.

  Eligibility

Ages Eligible for Study:   19 Months to 24 Months
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • No overt illness

Exclusion Criteria:

  • PPD reaction >15mm
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126217

Locations
Guinea-Bissau
Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
International Cooperation with Developing Countries
Leiden University Medical Centre, DEPT of Parasitology, Leiden Holland
Medical Research Council Unit, The Gambia
Investigators
Principal Investigator: Peter Aaby Bandim Health Project
  More Information

No publications provided

Responsible Party: Peter Aaby, Professor, Apartado 861, Bissau,Guinea-Bissau
ClinicalTrials.gov Identifier: NCT00126217     History of Changes
Other Study ID Numbers: ICA4-CT-2002-10053-REVAC, EU contract ICA4-CT-2002-10053
Study First Received: August 2, 2005
Last Updated: October 20, 2008
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Non-specific effects of vaccines
Infant mortality
Morbidity
Low income country
Malaria
BCG
immunisation
BCG revaccination
Tuberculin
Mortality

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 22, 2014