Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126217
Status:
TERMINATED
Last Update Posted:
2008-10-21
First Post:
2005-08-02
Brief Title:
Revaccination of Young Children With Bacille Calmette Guerin BCG Vaccine
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A cluster of deaths in the BCG-arm compared with controls
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Examine in a randomised trial whether revaccination with BCG reduces childhood mortality after 19 months of age by 30
Criteria for verification 3000 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 01 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 boostingno 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 revaccinationno 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
Criteria for verification 3000 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 01 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 boostingno 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 revaccinationno 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU contract ICA4-CT-2002-10053 | None | None | None |