title: Design of the leprosy component of the Brazilian BCG revaccination trial for assessing BCG effectiveness against leprosy in school children.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  Cluster randomized controlled field trial with no placebo.
  
  
  METHODS
  Children aged 7 to 14 years attending state schools with high coverage of neonatal BCG.
  
  
  METHODS
  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.
authors.affiliation: Instituto de Saúde Coletiva, Universidade Federal da Bahia, Brazil.
authors.forename: Sérgio S
authors.initials: SS
authors.lastname: Cunha
authors.forename: Inês
authors.initials: I
authors.lastname: Dourado
authors.forename: Mauricio L
authors.initials: ML
authors.lastname: Barreto
authors.forename: Neal
authors.initials: N
authors.lastname: Alexander
authors.forename: Susan M
authors.initials: SM
authors.lastname: Pereira
authors.forename: Yury
authors.initials: Y
authors.lastname: Ichihara
authors.forename: Emilia S
authors.initials: ES
authors.lastname: Pereira
authors.forename: Valderiza
authors.initials: V
authors.lastname: Pedrosa
authors.forename: Fatima
authors.initials: F
authors.lastname: Maroja
authors.forename: Carla
authors.initials: C
authors.lastname: Ribas
authors.forename: Laura C
authors.initials: LC
authors.lastname: Rodrigues
mesh_terms: D000293:Adolescent; D001500:BCG Vaccine / Q000008:administration & dosage*; D001938:Brazil / Q000453:epidemiology; D002648:Child; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007271:Injections, Intradermal; D007918:Leprosy / Q000453:epidemiology / Q000517:prevention & control*; D009166:Mycobacterium leprae; D014611:Vaccination
chemical_list: D001500:BCG Vaccine