@article{92, keywords = {Adolescent, BCG Vaccine, Brazil, Child, Female, Humans, Incidence, leprosy, Male, Vaccination}, author = {Cunha S and Alexander N and Barreto M and Pereira E and Dourado I and Maroja MF and Ichihara M and Brito SC and Pereira S and Rodrigues L}, title = {BCG revaccination does not protect against leprosy in the Brazilian Amazon: a cluster randomised trial.}, abstract = {
BACKGROUND: Although BCG has been found to impart protection against leprosy in many populations, the utility of repeat or booster BCG vaccinations is still unclear. When a policy of giving a second BCG dose to school children in Brazil was introduced, a trial was conducted to assess its impact against tuberculosis, and a leprosy component was then undertaken in parallel.
OBJECTIVE: to estimate the protection against leprosy imparted by a second dose of BCG given to schoolchildren.
METHODS AND FINDINGS: This is a cluster randomised community trial, with 6 years and 8 months of follow-up.
STUDY SITE: City of Manaus, Amazon region, a leprosy-endemic area in Brazil.
PARTICIPANTS: 99,770 school children with neonatal BCG (aged 7-14 years at baseline), of whom 42,662 were in the intervention arm (revaccination).
INTERVENTION: BCG given by intradermal injection.
MAIN OUTCOME: Leprosy (all clinical forms).
RESULTS: The incidence rate ratio of leprosy in the intervention over the control arm within the follow-up, in schoolchildren with neonatal BCG, controlled for potential confounders and adjusted for clustering, was 0.99 (95% confidence interval: 0.68 to 1.45).
CONCLUSIONS/SIGNIFICANCE: There was no evidence of protection conferred by the second dose of BCG vaccination in school children against leprosy during the trial follow-up. These results point to a need to consider the effectiveness of the current policy of BCG vaccination of contacts of leprosy cases in Brazilian Amazon region.
}, year = {2008}, journal = {PLoS neglected tropical diseases}, volume = {2}, pages = {e167}, month = {2008 Feb 13}, issn = {1935-2735}, url = {https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2238709/pdf/pntd.0000167.pdf}, doi = {10.1371/journal.pntd.0000167}, language = {eng}, }