Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis

Detalhes bibliográficos
Autor(a) principal: Aguiar-Soares, Rodrigo Dian de Oliveira
Data de Publicação: 2020
Outros Autores: Roatt, Bruno Mendes, Mathias, Fernando Augusto Siqueira, Reis, Levi Eduardo Soares, Cardoso, Jamille Mirelle de Oliveira, Brito, Rory Cristiane Fortes de, Ker, Henrique Gama, Oliveira, Rodrigo Corrêa de, Giunchetti, Rodolfo Cordeiro, Reis, Alexandre Barbosa
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/45654
Resumo: Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil / Universidade Federal de Ouro Preto. Escola de Farmácia. Departamento de Análises Clínicas. Ouro Preto, MG, Brazil.
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spelling Aguiar-Soares, Rodrigo Dian de OliveiraRoatt, Bruno MendesMathias, Fernando Augusto SiqueiraReis, Levi Eduardo SoaresCardoso, Jamille Mirelle de OliveiraBrito, Rory Cristiane Fortes deKer, Henrique GamaOliveira, Rodrigo Corrêa deGiunchetti, Rodolfo CordeiroReis, Alexandre Barbosa2021-01-12T17:00:15Z2021-01-12T17:00:15Z2020AGUIAR-SOARES, Rodrigo Dian de Oliveira et al. Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis. Vaccines, v. 8, n. 4, p. 1-17, 2020.2076-393Xhttps://www.arca.fiocruz.br/handle/icict/4565410.3390/vaccines8040690engMDPIPhase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil / Universidade Federal de Ouro Preto. Escola de Farmácia. Departamento de Análises Clínicas. Ouro Preto, MG, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil / Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Salvador, BA, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil.Fundação Oswaldo Cruz. Instituto René Rachou. Laboratório de Imunologia Celular e Molecular. Belo Horizonte, MG, Brazil.Universidade Federal de Minas Gerais. Departamento de Morfologia. Laboratório de Biologia das Interações Celulares. Belo Horizonte, MG, Brazil.Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil / Universidade Federal de Ouro Preto. Escola de Farmácia. Departamento de Análises Clínicas. Ouro Preto, MG, Brazil / Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais. Salvador, BA, Brazil.In this study, we performed a phase I and II clinical trial in dogs to evaluate the toxicity and immunogenicity of LBSap-vaccine prototype, in comparison to Leishmune® and Leish-Tec® vaccines. Twenty-eight dogs were classified in four groups: (i) control group received 1 mL of sterile 0.9% saline solution; (ii) LBSap group received 600 μg of Leishmania braziliensis promastigotes protein and 1 mg of saponin adjuvant; (iii) Leishmune®; and (iv) Leish-Tec®. The safety and toxicity of the vaccines were measured before and after three immunizations by clinical, biochemical, and hematological parameters. The clinical examinations revealed that some dogs of LBSap and Leishmune® groups presented changes at the site of vaccination inoculum, such as nodules, mild edema, and local pain, which were transient and disappeared seventy-two hours after vaccination, but these results indicate that adverse changes caused by the immunizations are tolerable. The immunogenicity results demonstrate an increase of B lymphocytes CD21+ regarding the Leishmune® group and monocytes CD14+ concerning LBSap and Leishmune® groups. In the in vitro analyses, an increase in lymphoproliferative activity in LBSap and Leishmune® groups was observed, with an increase of antigen-specific CD4+ and CD8+ T lymphocytes in the LBSap group. A second approach of in vitro assays aimed at evaluating the percentage of antigen-specific CD4+ and CD8+ T lymphocytes producers of IFN-γ and IL-4, where an increase in both IFN-γ producing subpopulations in the LBSap group was observed, also showed an increase in IFN-γ producers in CD8+ lymphocytes in the Leish-Tec® group. Our data regarding immunogenicity indicate that the vaccination process, especially with the LBSap vaccine, generated a protective immune response compatible with L. infantum parasite control. Based on the foregoing, the LBSap vaccine would be suitable for further studies of phase III clinical trial in endemic areas with high prevalence and incidence of canine visceral leishmaniasis (VL) cases.LBSapLeishmune®Leish-Tec®Leishmania infantumDogVaccinesVisceral leishmaniasisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83082https://www.arca.fiocruz.br/bitstream/icict/45654/1/license.txt9193a7c197bc67acd023525e72a03240MD51ORIGINALAguiar-Soares_Rodrigo_etal_IRR_2020.pdfAguiar-Soares_Rodrigo_etal_IRR_2020.pdfapplication/pdf9687932https://www.arca.fiocruz.br/bitstream/icict/45654/2/Aguiar-Soares_Rodrigo_etal_IRR_2020.pdf060b6d4e4d3955eabe7f9c84d4fd1c29MD52TEXTAguiar-Soares_Rodrigo_etal_IRR_2020.pdf.txtAguiar-Soares_Rodrigo_etal_IRR_2020.pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
title Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
spellingShingle Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
Aguiar-Soares, Rodrigo Dian de Oliveira
LBSap
Leishmune®
Leish-Tec®
Leishmania infantum
Dog
Vaccines
Visceral leishmaniasis
title_short Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
title_full Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
title_fullStr Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
title_full_unstemmed Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
title_sort Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
author Aguiar-Soares, Rodrigo Dian de Oliveira
author_facet Aguiar-Soares, Rodrigo Dian de Oliveira
Roatt, Bruno Mendes
Mathias, Fernando Augusto Siqueira
Reis, Levi Eduardo Soares
Cardoso, Jamille Mirelle de Oliveira
Brito, Rory Cristiane Fortes de
Ker, Henrique Gama
Oliveira, Rodrigo Corrêa de
Giunchetti, Rodolfo Cordeiro
Reis, Alexandre Barbosa
author_role author
author2 Roatt, Bruno Mendes
Mathias, Fernando Augusto Siqueira
Reis, Levi Eduardo Soares
Cardoso, Jamille Mirelle de Oliveira
Brito, Rory Cristiane Fortes de
Ker, Henrique Gama
Oliveira, Rodrigo Corrêa de
Giunchetti, Rodolfo Cordeiro
Reis, Alexandre Barbosa
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Aguiar-Soares, Rodrigo Dian de Oliveira
Roatt, Bruno Mendes
Mathias, Fernando Augusto Siqueira
Reis, Levi Eduardo Soares
Cardoso, Jamille Mirelle de Oliveira
Brito, Rory Cristiane Fortes de
Ker, Henrique Gama
Oliveira, Rodrigo Corrêa de
Giunchetti, Rodolfo Cordeiro
Reis, Alexandre Barbosa
dc.subject.en.pt_BR.fl_str_mv LBSap
Leishmune®
Leish-Tec®
Leishmania infantum
Dog
Vaccines
Visceral leishmaniasis
topic LBSap
Leishmune®
Leish-Tec®
Leishmania infantum
Dog
Vaccines
Visceral leishmaniasis
description Universidade Federal de Ouro Preto. Núcleo de Pesquisas em Ciências Biológicas. Laboratório de Imunopatologia. Ouro Preto, MG, Brazil / Universidade Federal de Ouro Preto. Escola de Farmácia. Departamento de Análises Clínicas. Ouro Preto, MG, Brazil.
publishDate 2020
dc.date.issued.fl_str_mv 2020
dc.date.accessioned.fl_str_mv 2021-01-12T17:00:15Z
dc.date.available.fl_str_mv 2021-01-12T17:00:15Z
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 AGUIAR-SOARES, Rodrigo Dian de Oliveira et al. Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis. Vaccines, v. 8, n. 4, p. 1-17, 2020.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/45654
dc.identifier.issn.pt_BR.fl_str_mv 2076-393X
dc.identifier.doi.none.fl_str_mv 10.3390/vaccines8040690
identifier_str_mv AGUIAR-SOARES, Rodrigo Dian de Oliveira et al. Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis. Vaccines, v. 8, n. 4, p. 1-17, 2020.
2076-393X
10.3390/vaccines8040690
url https://www.arca.fiocruz.br/handle/icict/45654
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 MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
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https://www.arca.fiocruz.br/bitstream/icict/45654/3/Aguiar-Soares_Rodrigo_etal_IRR_2020.pdf.txt
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