title: Cluster randomised trial to evaluate the effectiveness of a vaccine against cutaneous leishmaniasis in the Caratinga microregion, south-east Brazil.
abstract: BACKGROUND
  The eco-epidemiological complexity of American cutaneous leishmaniasis (ACL) has made it difficult to devise an efficient strategy for management of the disease, and development of an effective vaccine remains the most promising approach. The objective of the study was to determine the reduction in incidence of ACL following intramuscular administration of two doses of a killed Leishmania (Leishmania) amazonensis vaccine.
  
  
  METHODS
  A cluster randomised trial was conducted from 2002 to 2011 in 108 localities in an endemic area of southeast Brazil. Communities were stratified according to population size, and randomly allocated to receive vaccine (n = 50) or placebo (n = 58). The post-vaccination ACL incidence rates in the two groups were compared through covariance analysis.
  
  
  RESULTS
  A cyclic fluctuation in the number of cases recorded during the 18-year pre-vaccination period was similar in both groups. Following the vaccination campaign, a significant reduction in the number of cases of ACL was observed in the vaccine group compared with the placebo group. This group also included the individuals who refused to participate in the trial.
  
  
  CONCLUSIONS
  This study demonstrated that the vaccine has been able to confer protection against ACL up to the present time. It is necessary to continue epidemiological surveillance to determine the duration of the vaccine's effectiveness.
authors: Laboratório de Leishmanioses e Vacinas, Departamento de Parasitologia, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
authors: Wilson
authors: W
authors: Mayrink
authors: Alekson
authors: A
authors: Mendonça-Mendes
authors: Jair Cecílio
authors: JC
authors: de Paula
authors: Liliane Maria Vidal
authors: LM
authors: Siqueira
authors: Simone de Resende
authors: Sde R
authors: Marrocos
authors: Edelberto Santos
authors: ES
authors: Dias
authors: Hélida Monteiro
authors: HM
authors: de Andrade
authors: George Luiz Lins
authors: GL
authors: Machado-Coelho
mesh_terms: D000293:Adolescent; D000328:Adult; D001938:Brazil / Q000453:epidemiology; D002648:Child; D016000:Cluster Analysis; D005260:Female; D006801:Humans; D015994:Incidence; D007273:Injections, Intramuscular; D054332:Leishmaniasis Vaccines / Q000008:administration & dosage; D016773:Leishmaniasis, Cutaneous / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D032541:Mass Vaccination / Q000379:methods*; D055815:Young Adult
chemical_list: D054332:Leishmaniasis Vaccines