Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil.
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFOP |
Texto Completo: | http://www.repositorio.ufop.br/handle/123456789/6596 https://doi.org/10.1016/j.vaccine.2016.03.019 |
Resumo: | Background: A canine vaccine remains a promising approach for effective control of visceral leishmaniasis(VL), given its complex epidemiology in areas where zoonotic VL is prevalent. Leish-Tec®is a recombi-nant vaccine, based on the Leishmania A2 antigen, against canine VL (CVL). It is, since 2014, the singlecommercial vaccine licensed in Brazil. Here, Leish-Tec®efficacy was estimated through a randomizedfield trial (RFT), in a highly VL endemic area.Methods: The RFT was conducted from 2008 to 2010 in an endemic area of southeastern Brazil, presentinga CVL seroprevalence of 41.9%. Eight hundred forty-seven seronegative dogs were randomly selected toreceive Leish-Tec®(n = 429) or placebo (n = 418). Animals were followed up by clinical, serological, andparasitological exams for 18 months. The CVL incidence in both groups was compared through proportionanalysis.Results: A significant reduction in the number of cases of CVL was observed in the vaccine group, ascompared with the placebo group, whether efficacy was estimated according to parasitological results(71.4%; 95% CI: 34.9–87.3%; p = 0.001; risk ratio = 0.287), by adding results of xenodiagnosis and parasito-logical exams (58.1%; 95% CI: 26.0–76.3%; p = 0.002; risk ratio = 0.419). Among the animals that convertedto a positive anti-A2 serology, efficacy reached 80.8% (95% CI: 37.6–94.1%, p = 0.001; risk ratio = 0.192).Xenodiagnosis has detected a reduction of 46.6% (p = 0.05) in transmission to sand flies from vaccinatedanimals presenting anti-A2 positive serology.Conclusion: The Leish-Tec®vaccine proved significantly effective for prophylaxis of CVL, after naturalchallenge assured by transmission of Leishmania parasites, in a highly endemic area. Noteworthy, thisreport has unveiled the complexity of performing a RFT for anti-CVL vaccines in Brazil, which may behelpful for designing of future studies. |
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Silva, Shara ReginaFeres, Ana Maria Leonardi TibúrcioSilva, João Carlos França daDias, Edelberto SantosMichalsky, Érika MonteiroAndrade, Hélida Monteiro deCoelho, Eduardo Antônio FerrazRibeiro, Gustavo MeirellesFernandes, Ana PaulaCoelho, George Luiz Lins Machado2016-07-22T16:05:50Z2016-07-22T16:05:50Z2016SILVA, S. R. et al. Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. Vaccine (Guildford), v. 34, p. 2233-2239, 2016. Disponível em: <http://www.sciencedirect.com/science/article/pii/S0264410X16003303>. Acesso em: 16 jun. 2016.0264-410Xhttp://www.repositorio.ufop.br/handle/123456789/6596https://doi.org/10.1016/j.vaccine.2016.03.019Background: A canine vaccine remains a promising approach for effective control of visceral leishmaniasis(VL), given its complex epidemiology in areas where zoonotic VL is prevalent. Leish-Tec®is a recombi-nant vaccine, based on the Leishmania A2 antigen, against canine VL (CVL). It is, since 2014, the singlecommercial vaccine licensed in Brazil. Here, Leish-Tec®efficacy was estimated through a randomizedfield trial (RFT), in a highly VL endemic area.Methods: The RFT was conducted from 2008 to 2010 in an endemic area of southeastern Brazil, presentinga CVL seroprevalence of 41.9%. Eight hundred forty-seven seronegative dogs were randomly selected toreceive Leish-Tec®(n = 429) or placebo (n = 418). Animals were followed up by clinical, serological, andparasitological exams for 18 months. The CVL incidence in both groups was compared through proportionanalysis.Results: A significant reduction in the number of cases of CVL was observed in the vaccine group, ascompared with the placebo group, whether efficacy was estimated according to parasitological results(71.4%; 95% CI: 34.9–87.3%; p = 0.001; risk ratio = 0.287), by adding results of xenodiagnosis and parasito-logical exams (58.1%; 95% CI: 26.0–76.3%; p = 0.002; risk ratio = 0.419). Among the animals that convertedto a positive anti-A2 serology, efficacy reached 80.8% (95% CI: 37.6–94.1%, p = 0.001; risk ratio = 0.192).Xenodiagnosis has detected a reduction of 46.6% (p = 0.05) in transmission to sand flies from vaccinatedanimals presenting anti-A2 positive serology.Conclusion: The Leish-Tec®vaccine proved significantly effective for prophylaxis of CVL, after naturalchallenge assured by transmission of Leishmania parasites, in a highly endemic area. Noteworthy, thisreport has unveiled the complexity of performing a RFT for anti-CVL vaccines in Brazil, which may behelpful for designing of future studies.O periódico Vaccine concede permissão para depósito deste artigo no Repositório Institucional da UFOP. Número da licença: 3894171189856.info:eu-repo/semantics/openAccessRandomized field trialCanine visceral leishmaniasisVaccineEfficacyField randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleengreponame:Repositório Institucional da UFOPinstname:Universidade Federal de Ouro Preto (UFOP)instacron:UFOPLICENSElicense.txtlicense.txttext/plain; charset=utf-8924http://www.repositorio.ufop.br/bitstream/123456789/6596/2/license.txt62604f8d955274beb56c80ce1ee5dcaeMD52ORIGINALARTIGO_FieldRandomizedTrial.pdfARTIGO_FieldRandomizedTrial.pdfapplication/pdf800168http://www.repositorio.ufop.br/bitstream/123456789/6596/1/ARTIGO_FieldRandomizedTrial.pdf91dba759f661af889cd481104d7f3908MD51123456789/65962019-09-19 13:24:30.571oai:localhost: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ório InstitucionalPUBhttp://www.repositorio.ufop.br/oai/requestrepositorio@ufop.edu.bropendoar:32332019-09-19T17:24:30Repositório Institucional da UFOP - Universidade Federal de Ouro Preto (UFOP)false |
dc.title.pt_BR.fl_str_mv |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
title |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
spellingShingle |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. Silva, Shara Regina Randomized field trial Canine visceral leishmaniasis Vaccine Efficacy |
title_short |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
title_full |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
title_fullStr |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
title_full_unstemmed |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
title_sort |
Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. |
author |
Silva, Shara Regina |
author_facet |
Silva, Shara Regina Feres, Ana Maria Leonardi Tibúrcio Silva, João Carlos França da Dias, Edelberto Santos Michalsky, Érika Monteiro Andrade, Hélida Monteiro de Coelho, Eduardo Antônio Ferraz Ribeiro, Gustavo Meirelles Fernandes, Ana Paula Coelho, George Luiz Lins Machado |
author_role |
author |
author2 |
Feres, Ana Maria Leonardi Tibúrcio Silva, João Carlos França da Dias, Edelberto Santos Michalsky, Érika Monteiro Andrade, Hélida Monteiro de Coelho, Eduardo Antônio Ferraz Ribeiro, Gustavo Meirelles Fernandes, Ana Paula Coelho, George Luiz Lins Machado |
author2_role |
author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Silva, Shara Regina Feres, Ana Maria Leonardi Tibúrcio Silva, João Carlos França da Dias, Edelberto Santos Michalsky, Érika Monteiro Andrade, Hélida Monteiro de Coelho, Eduardo Antônio Ferraz Ribeiro, Gustavo Meirelles Fernandes, Ana Paula Coelho, George Luiz Lins Machado |
dc.subject.por.fl_str_mv |
Randomized field trial Canine visceral leishmaniasis Vaccine Efficacy |
topic |
Randomized field trial Canine visceral leishmaniasis Vaccine Efficacy |
description |
Background: A canine vaccine remains a promising approach for effective control of visceral leishmaniasis(VL), given its complex epidemiology in areas where zoonotic VL is prevalent. Leish-Tec®is a recombi-nant vaccine, based on the Leishmania A2 antigen, against canine VL (CVL). It is, since 2014, the singlecommercial vaccine licensed in Brazil. Here, Leish-Tec®efficacy was estimated through a randomizedfield trial (RFT), in a highly VL endemic area.Methods: The RFT was conducted from 2008 to 2010 in an endemic area of southeastern Brazil, presentinga CVL seroprevalence of 41.9%. Eight hundred forty-seven seronegative dogs were randomly selected toreceive Leish-Tec®(n = 429) or placebo (n = 418). Animals were followed up by clinical, serological, andparasitological exams for 18 months. The CVL incidence in both groups was compared through proportionanalysis.Results: A significant reduction in the number of cases of CVL was observed in the vaccine group, ascompared with the placebo group, whether efficacy was estimated according to parasitological results(71.4%; 95% CI: 34.9–87.3%; p = 0.001; risk ratio = 0.287), by adding results of xenodiagnosis and parasito-logical exams (58.1%; 95% CI: 26.0–76.3%; p = 0.002; risk ratio = 0.419). Among the animals that convertedto a positive anti-A2 serology, efficacy reached 80.8% (95% CI: 37.6–94.1%, p = 0.001; risk ratio = 0.192).Xenodiagnosis has detected a reduction of 46.6% (p = 0.05) in transmission to sand flies from vaccinatedanimals presenting anti-A2 positive serology.Conclusion: The Leish-Tec®vaccine proved significantly effective for prophylaxis of CVL, after naturalchallenge assured by transmission of Leishmania parasites, in a highly endemic area. Noteworthy, thisreport has unveiled the complexity of performing a RFT for anti-CVL vaccines in Brazil, which may behelpful for designing of future studies. |
publishDate |
2016 |
dc.date.accessioned.fl_str_mv |
2016-07-22T16:05:50Z |
dc.date.available.fl_str_mv |
2016-07-22T16:05:50Z |
dc.date.issued.fl_str_mv |
2016 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
SILVA, S. R. et al. Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. Vaccine (Guildford), v. 34, p. 2233-2239, 2016. Disponível em: <http://www.sciencedirect.com/science/article/pii/S0264410X16003303>. Acesso em: 16 jun. 2016. |
dc.identifier.uri.fl_str_mv |
http://www.repositorio.ufop.br/handle/123456789/6596 |
dc.identifier.issn.none.fl_str_mv |
0264-410X |
dc.identifier.doi.none.fl_str_mv |
https://doi.org/10.1016/j.vaccine.2016.03.019 |
identifier_str_mv |
SILVA, S. R. et al. Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil. Vaccine (Guildford), v. 34, p. 2233-2239, 2016. Disponível em: <http://www.sciencedirect.com/science/article/pii/S0264410X16003303>. Acesso em: 16 jun. 2016. 0264-410X |
url |
http://www.repositorio.ufop.br/handle/123456789/6596 https://doi.org/10.1016/j.vaccine.2016.03.019 |
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eng |
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