Phase I and II Clinical Trial Comparing the LBSap, Leishmune®, and Leish-Tec® Vaccines against Canine Visceral Leishmaniasis
Autor(a) principal: | |
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Data de Publicação: | 2020 |
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/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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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 |
format |
article |
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 |
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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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MDPI |
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MDPI |
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