Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine
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|ClinicalTrials.gov Identifier: NCT00126217|
Recruitment Status : Terminated (A cluster of deaths in the BCG-arm compared with controls)
First Posted : August 3, 2005
Last Update Posted : October 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Biological: Bacille Calmette Guerin (BCG)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2871 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||September 2006|
Biological: Bacille Calmette Guerin (BCG)
0,1 ml, revaccination at 19 months of age
|No Intervention: 2|
- Mortality till 5 years of age
- Hospitalisations till 5 years of age
- Adverse effects within 12 months after intervention
- 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
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): NCT00126217
|Bandim Health Project|
|Apartado 861, Bissau, Guinea-Bissau|
|Principal Investigator:||Peter Aaby||Bandim Health Project|