Design of the leprosy component of the Brazilian BCG revaccination trial for assessing BCG effectiveness against leprosy in school children.
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.
Cunha
Sérgio S
SS
Instituto de Saúde Coletiva, Universidade Federal da Bahia, Brazil.
Dourado
Inês
I
Barreto
Mauricio L
ML
Alexander
Neal
N
Pereira
Susan M
SM
Ichihara
Yury
Y
Pereira
Emilia S
ES
Pedrosa
Valderiza
V
Maroja
Fatima
F
Ribas
Carla
C
Rodrigues
Laura C
LC
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
D001500:BCG Vaccine