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 FIOCRUZ (ARCA) |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/16288 |
Resumo: | 2021-01-01 |
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Silva, Shara Regina daFeres, Ana Maria Leonardi TibúrcioSilva, João Carlos FrançaDias, Edelberto SantosMichalsky, Érika MonteiroAndrade, Hélida Monteiro deCoelho, Eduardo Antônio FerrazRibeiro, Gustavo MeirellesFernandes, Ana PaulaCoelho, George Luiz Lins Machado2016-10-18T18:28:04Z2016-10-18T18:28:04Z2016SILVA, Shara Regina 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, 2016.0264-410Xhttps://www.arca.fiocruz.br/handle/icict/1628810.1016/j.vaccine.2016.03.019engElsevier B.V.leishmaniose visceral caninaRandomized field trialCanine visceral leishmaniasisVaccineA2 antigenEfficacyField randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article2021-01-01Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, BrasilInova Biotecnologia Saúde Animal Ltda. Juatuba, MG, BrasilUniversidade Federal de Minas Gerais. Departamento de Parasitologia. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, BrasilFundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, BrasilUniversidade Federal de Minas Gerais. Departamento de Parasitologia. Belo Horizonte, MG, BrasilUniversidade Federal de Minas Gerais. Colégio Técnico. Setor de Patologia Clínica. Belo Horizonte, MG, BrasilUniversidade Federal de Ouro Preto. Escola de Medicina. Ouro Preto, MG, BrasilUniversidade Federal de Minas Gerais. Faculdade de Farmácia. Belo Horizonte, MG, BrasilUniversidade Federal de Ouro Preto. Escola de Medicina. Ouro Preto, MG, BrasilBackground: 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.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/16288/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALve_Silva_Shara_Field randomized_CPqRR_2016.pdfve_Silva_Shara_Field randomized_CPqRR_2016.pdfapplication/pdf800168https://www.arca.fiocruz.br/bitstream/icict/16288/2/ve_Silva_Shara_Field%20randomized_CPqRR_2016.pdf91dba759f661af889cd481104d7f3908MD52TEXTve_Silva_Shara_Field randomized_CPqRR_2016.pdf.txtve_Silva_Shara_Field randomized_CPqRR_2016.pdf.txtExtracted 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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 da leishmaniose visceral canina Randomized field trial Canine visceral leishmaniasis Vaccine A2 antigen 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 da |
author_facet |
Silva, Shara Regina da Feres, Ana Maria Leonardi Tibúrcio Silva, João Carlos França 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 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 da Feres, Ana Maria Leonardi Tibúrcio Silva, João Carlos França 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.other.pt_BR.fl_str_mv |
leishmaniose visceral canina |
topic |
leishmaniose visceral canina Randomized field trial Canine visceral leishmaniasis Vaccine A2 antigen Efficacy |
dc.subject.en.pt_BR.fl_str_mv |
Randomized field trial Canine visceral leishmaniasis Vaccine A2 antigen Efficacy |
description |
2021-01-01 |
publishDate |
2016 |
dc.date.accessioned.fl_str_mv |
2016-10-18T18:28:04Z |
dc.date.available.fl_str_mv |
2016-10-18T18:28:04Z |
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, Shara Regina 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. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/16288 |
dc.identifier.issn.pt_BR.fl_str_mv |
0264-410X |
dc.identifier.doi.none.fl_str_mv |
10.1016/j.vaccine.2016.03.019 |
identifier_str_mv |
SILVA, Shara Regina 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. 0264-410X 10.1016/j.vaccine.2016.03.019 |
url |
https://www.arca.fiocruz.br/handle/icict/16288 |
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eng |
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eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
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Elsevier B.V. |
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Elsevier B.V. |
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