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2100-01-01
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CLUSTER RANDOMISED TRIAL TO EVALUATE THE EFFECTIVENESS OF A VACCINE AGAINST CUTANEOUS LEISHMANIASIS IN THE CARATINGA MICROREGION, SOUTH-EAST BRAZIL.
Leishmaniose cutânea
vacina
Tendências temporais
Eficácia
Author
Affilliation
Universidade Federal de Minas Gerais. Departamento de Parasitologia. Laboratorio de Leishmanioses e Vacinas. Belo Horizonte, MG, Brazil
Universidade Federal de Ouro Preto. Nucleo de Pesquisa em Ciencias Biologicas. Ouro Preto, MG, Brazil
Unidade Descentralizada de Saude de Caratinga. Caratinga, MG, Brazil
Universidade Federal de Ouro Preto. Escola de Medicina. Laboratorio de Epidemiologia de Doencas Parasitarias. Ouro Preto, MG, Brazil
Secretaria de Estado de Saude de Minas Gerais. Superintendencia Regional de Saude de Belo Horizonte. Belo Horizonte, MG, Brazil
Fundação Oswaldo Cruz. Centro de Pesquisa Rene Rachou. Laboratorio de Leishmanioses. Belo Horizonte, MG, Brazil
Universidade Federal de Minas Gerais. Departamento de Parasitologia. Laboratorio de Leishmanioses e Vacinas. Belo Horizonte, MG, Brazil
Universidade Federal de Ouro Preto. Nucleo de Pesquisa em Ciencias Biologicas. Ouro Preto, MG, Brazil/Universidade Federal de Ouro Preto. Escola de Medicina. Laboratorio de Epidemiologia de Doencas Parasitarias. Ouro Preto, MG, Brazil
Universidade Federal de Ouro Preto. Nucleo de Pesquisa em Ciencias Biologicas. Ouro Preto, MG, Brazil
Unidade Descentralizada de Saude de Caratinga. Caratinga, MG, Brazil
Universidade Federal de Ouro Preto. Escola de Medicina. Laboratorio de Epidemiologia de Doencas Parasitarias. Ouro Preto, MG, Brazil
Secretaria de Estado de Saude de Minas Gerais. Superintendencia Regional de Saude de Belo Horizonte. Belo Horizonte, MG, Brazil
Fundação Oswaldo Cruz. Centro de Pesquisa Rene Rachou. Laboratorio de Leishmanioses. Belo Horizonte, MG, Brazil
Universidade Federal de Minas Gerais. Departamento de Parasitologia. Laboratorio de Leishmanioses e Vacinas. Belo Horizonte, MG, Brazil
Universidade Federal de Ouro Preto. Nucleo de Pesquisa em Ciencias Biologicas. Ouro Preto, MG, Brazil/Universidade Federal de Ouro Preto. Escola de Medicina. Laboratorio de Epidemiologia de Doencas Parasitarias. Ouro Preto, MG, 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 ¼ 50) or placebo (n ¼ 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.
Conclusion: 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.
Keywords in Portuguese
Ensaio randomizado por clustersLeishmaniose cutânea
vacina
Tendências temporais
Eficácia
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