02557nas a2200409   4500000000100000008004100001260001300042653001500055653001600070653001100086653001000097653002200107653001100129653001400140653002800154653001200182653002500194653001600219100001200235700001400247700001400261700001600275700001400291700001500305700001400320700001500334700001300349700001200362700001600374245014500390856004100535300000900576490000700585050001500592520152600607022001402133       2004                            d  c2004 Mar10aAdolescent10aBCG Vaccine10aBrazil10aChild10aFollow-Up Studies10aHumans10aIncidence10aInjections, Intradermal10aleprosy10aMycobacterium leprae10aVaccination1 aCunha S1 aDourado I1 aBarreto M1 aAlexander N1 aPereira S1 aIchihara M1 aPereira E1 aPedrosa VL1 aMaroja F1 aRibas C1 aRodrigues L00aDesign of the leprosy component of the Brazilian BCG revaccination trial for assessing BCG effectiveness against leprosy in school children.  uhttp://ila.ilsl.br/pdfs/v72n1a02.pdf  a8-150 v72  aCUNHA 20043 a<p><b>BACKGROUND: </b>BCG vaccination confers protection against leprosy, and vaccination among household contacts has been recommended in Brazil. Nevertheless, vaccination of the entire community against leprosy is not advocated as leprosy has low incidence in most populations. Despite that, in Brazil, BCG vaccination is recommended among school children to prevent tuberculosis and this large scale vaccination may also affect the occurrence of leprosy, which led to investigations of its impact on leprosy in endemic areas of Brazil.</p><p><b>OBJECTIVES: </b>To estimate the effectiveness against leprosy of a dose of BCG vaccine given to school children in a population with a high coverage of neonatal BCG. Long term objectives are to compare the impact of vaccination among schoolchildren with the existing recommendation to vaccinate household contacts of leprosy.</p><p><b>STUDY DESIGN: </b>Cluster randomized controlled field trial with no placebo.</p><p><b>STUDY POPULATION: </b>Children aged 7 to 14 years attending state schools with high coverage of neonatal BCG.</p><p><b>METHODS: </b>286 state schools in the city of Manaus, Brazil, were randomized to receive BCG or not. Identifying information was collected for 152,438 school children, of whom 72,980 are in intervention schools. BCG vaccination was given intradermically to children in schools allocated to vaccination. Follow-up relies on ascertainement of cases diagnosed at the health services and notified to the reference center for leprosy.</p>  a0148-916X