Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil

Detalhes bibliográficos
Autor(a) principal: Silva, Shara Regina da
Data de Publicação: 2016
Outros Autores: 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
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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spelling 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
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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
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier B.V.
publisher.none.fl_str_mv Elsevier B.V.
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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