| Author | Silva, Shara Regina da | |
| Author | Feres, Ana Maria Leonardi Tibúrcio | |
| Author | Silva, João Carlos França | |
| Author | Dias, Edelberto Santos | |
| Author | Michalsky, Érika Monteiro | |
| Author | Andrade, Hélida Monteiro de | |
| Author | Coelho, Eduardo Antônio Ferraz | |
| Author | Ribeiro, Gustavo Meirelles | |
| Author | Fernandes, Ana Paula | |
| Author | Coelho, George Luiz Lins Machado | |
| Access date | 2016-10-18T18:28:04Z | |
| Available date | 2016-10-18T18:28:04Z | |
| Document date | 2016 | |
| Citation | 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. | pt_BR |
| ISSN | 0264-410X | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/16288 | |
| Language | eng | pt_BR |
| Publisher | Elsevier B.V. | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | leishmaniose visceral canina | pt_BR |
| Title | Field randomized trial to evaluate the efficacy of the Leish - Tec vaccine against canine visceral leishmaniasis in anendemic area of Brazil | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1016/j.vaccine.2016.03.019 | |
| Abstract | 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. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Inova Biotecnologia Saúde Animal Ltda. Juatuba, MG, Brasil | pt_BR |
| Affilliation | Universidade Federal de Minas Gerais. Departamento de Parasitologia. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Universidade Federal de Minas Gerais. Departamento de Parasitologia. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Universidade Federal de Minas Gerais. Colégio Técnico. Setor de Patologia Clínica. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Universidade Federal de Ouro Preto. Escola de Medicina. Ouro Preto, MG, Brasil | pt_BR |
| Affilliation | Universidade Federal de Minas Gerais. Faculdade de Farmácia. Belo Horizonte, MG, Brasil | pt_BR |
| Affilliation | Universidade Federal de Ouro Preto. Escola de Medicina. Ouro Preto, MG, Brasil | pt_BR |
| Subject | Randomized field trial | pt_BR |
| Subject | Canine visceral leishmaniasis | pt_BR |
| Subject | Vaccine | pt_BR |
| Subject | A2 antigen | pt_BR |
| Subject | Efficacy | pt_BR |
| Embargo date | 2021-01-01 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
