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Trial NCT00126217

Resource URI: http://static.linkedct.org/resource/trials/NCT00126217
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13830>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/188>
linkedct:brief_title Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/4049>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/4618>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/4959>
linkedct:condition <http://static.linkedct.org/resource/condition/7686>
linkedct:criteria Inclusion Criteria: - No overt illness Exclusion Criteria: - PPD reaction >15mm
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_maximum_age 24 Months
linkedct:eligibility_minimum_age 19 Months
linkedct:end_date September 2006
linkedct:enrollment 2871 (xsd:int)
linkedct:firstreceived_date August 2, 2005
linkedct:id NCT00126217
linkedct:intervention <http://static.linkedct.org/resource/intervention/69799>
rdfs:label Trial NCT00126217
linkedct:lastchanged_date October 20, 2008
linkedct:lead_sponsor_agency Bandim Health Project
linkedct:location <http://static.linkedct.org/resource/location/68637>
linkedct:nct_id NCT00126217
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct: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.
linkedct:org_study_id ICA4-CT-2002-10053-REVAC
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/46473>
linkedct:overall_status Terminated
linkedct:oversight <http://static.linkedct.org/resource/oversight/1249>
foaf:page <http://clinicaltrials.gov/show/NCT00126217>
linkedct:phase Phase 4
linkedct:primary_completion_date May 2006
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/10133>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/13254>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/1497>
linkedct:secondary_id EU contract ICA4-CT-2002-10053
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/102477>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/10742>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/129933>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/63533>
linkedct:source Bandim Health Project
linkedct:start_date July 2002
linkedct:study_design Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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%.
rdf:type linkedct:trials
linkedct:verification_date October 2008
linkedct:why_stopped A cluster of deaths in the BCG-arm compared with controls