Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]

Current vaccines for canine leishmaniosis (CanL) provide limited protection, underscoring the need for improved immunization strategies. Multi-epitope peptide vaccine delivered via nanoparticle systems represents a promising alternative but remains underexplored in canine clinical trials. Here, we r...

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Autores: Hurtado-Morillas, Clara, Mas, Alicia, Orden, José A., Urbina-Fuentes, Laura de, Blanco, María Del Mar, Domínguez-Bernal, Gustavo, Martínez-Rodrigo, Abel
Tipo de recurso: conjunto de datos
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/416382
Acceso en línea:http://hdl.handle.net/10261/416382
https://doi.org/10.20350/digitalCSIC/17917
Access Level:acceso abierto
Palabra clave:Canine leishmaniosis
Multi-epitope vaccines
PLGA nanoparticles
Cell immunity
Veterinary clinical trial
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spelling Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]Hurtado-Morillas, ClaraMas, AliciaOrden, José A.Urbina-Fuentes, Laura deBlanco, María Del MarDomínguez-Bernal, GustavoMartínez-Rodrigo, AbelCanine leishmaniosisMulti-epitope vaccinesPLGA nanoparticlesCell immunityVeterinary clinical trialCurrent vaccines for canine leishmaniosis (CanL) provide limited protection, underscoring the need for improved immunization strategies. Multi-epitope peptide vaccine delivered via nanoparticle systems represents a promising alternative but remains underexplored in canine clinical trials. Here, we report the results of a double-blind clinical trial (499/ECV) evaluating the safety and immunogenicity of HisDTC, a peptide vaccine targeting Leishmania infantum, encapsulated in poly(lactic-co-glycolic acid) PLGA nanoparticles and adjuvanted with Toll-like receptor 2 (TLR2) and TLR3 ligands. Forty healthy dogs were immunized with different vaccine formulations and monitored over 12 months. Immune responses were assessed by flow cytometry, ELISA, and in vitro macrophage infection assays, while safety was evaluated through clinical follow-up. Vaccination with HisDTC elicited a protective cellular response, including sustained IFN-γ production by CD4+ and CD8+ T cells, an IgG2a-skewed humoral response, and expansion of CD4+CD8α+ double-positive memory T cells. Notably, only HisDTC-vaccinated dogs exhibited a >80% reduction in in vitro macrophage infection, with protective effects persisting for up to 8 months post-immunization. Importantly, the formulation was well tolerated, with no adverse effects reported. These findings demonstrate that HisDTC delivered via PLGA nanoparticles induces durable, protective immunity against L. infantum in dogs and supports its further evaluation under natural exposure conditions.This research was supported by the grants PID2019-106487RB-I00 and PID2023-146579OB-I00 funded by Ministerio de Ciencia, Innovación y Universidades/Agencia Estatal de Investigación/AEI/10.13039/501100011033.Peer reviewedFigshareAgencia Estatal de Investigación (España)Ministerio de Ciencia, Innovación y Universidades (España)European CommissionHurtado-Morillas, Clara [0000-0001-8041-4980]Mas, Alicia [0000-0001-8947-3207]Orden, J. A. [0000-0001-6352-1426]Domínguez-Bernal, G. [0000-0002-7693-653X]Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202620262025info:eu-repo/semantics/datasethttp://purl.org/coar/resource_type/c_ddb1Publisher's versioninfo:eu-repo/semantics/publishedVersionapplication/pdftext/csvhttp://hdl.handle.net/10261/416382https://doi.org/10.20350/digitalCSIC/17917reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Inglés#PLACEHOLDER_PARENT_METADATA_VALUE#info:eu-repo/grantAgreement/AEI/Plan Estatal de Investigación Científica y Técnica y de Innovación 2021-2023/PID2023-146579OB-I00Hurtado-Morillas, Clara; Mas, Alicia; Orden, José A.; Urbina-Fuentes, Laura de; Blanco, María Del Mar; Domínguez-Bernal, Gustavo; Martínez-Rodrigo, Abel. Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs. https://doi.org/10.1080/01652176.2025.2591396. http://hdl.handle.net/10261/416378https://doi.org/10.6084/m9.figshare.30796923Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/4163822026-05-22T06:33:51Z
dc.title.none.fl_str_mv Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
title Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
spellingShingle Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
Hurtado-Morillas, Clara
Canine leishmaniosis
Multi-epitope vaccines
PLGA nanoparticles
Cell immunity
Veterinary clinical trial
title_short Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
title_full Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
title_fullStr Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
title_full_unstemmed Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
title_sort Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs [Dataset]
dc.creator.none.fl_str_mv Hurtado-Morillas, Clara
Mas, Alicia
Orden, José A.
Urbina-Fuentes, Laura de
Blanco, María Del Mar
Domínguez-Bernal, Gustavo
Martínez-Rodrigo, Abel
author Hurtado-Morillas, Clara
author_facet Hurtado-Morillas, Clara
Mas, Alicia
Orden, José A.
Urbina-Fuentes, Laura de
Blanco, María Del Mar
Domínguez-Bernal, Gustavo
Martínez-Rodrigo, Abel
author_role author
author2 Mas, Alicia
Orden, José A.
Urbina-Fuentes, Laura de
Blanco, María Del Mar
Domínguez-Bernal, Gustavo
Martínez-Rodrigo, Abel
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Agencia Estatal de Investigación (España)
Ministerio de Ciencia, Innovación y Universidades (España)
European Commission
Hurtado-Morillas, Clara [0000-0001-8041-4980]
Mas, Alicia [0000-0001-8947-3207]
Orden, J. A. [0000-0001-6352-1426]
Domínguez-Bernal, G. [0000-0002-7693-653X]
Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Canine leishmaniosis
Multi-epitope vaccines
PLGA nanoparticles
Cell immunity
Veterinary clinical trial
topic Canine leishmaniosis
Multi-epitope vaccines
PLGA nanoparticles
Cell immunity
Veterinary clinical trial
description Current vaccines for canine leishmaniosis (CanL) provide limited protection, underscoring the need for improved immunization strategies. Multi-epitope peptide vaccine delivered via nanoparticle systems represents a promising alternative but remains underexplored in canine clinical trials. Here, we report the results of a double-blind clinical trial (499/ECV) evaluating the safety and immunogenicity of HisDTC, a peptide vaccine targeting Leishmania infantum, encapsulated in poly(lactic-co-glycolic acid) PLGA nanoparticles and adjuvanted with Toll-like receptor 2 (TLR2) and TLR3 ligands. Forty healthy dogs were immunized with different vaccine formulations and monitored over 12 months. Immune responses were assessed by flow cytometry, ELISA, and in vitro macrophage infection assays, while safety was evaluated through clinical follow-up. Vaccination with HisDTC elicited a protective cellular response, including sustained IFN-γ production by CD4+ and CD8+ T cells, an IgG2a-skewed humoral response, and expansion of CD4+CD8α+ double-positive memory T cells. Notably, only HisDTC-vaccinated dogs exhibited a >80% reduction in in vitro macrophage infection, with protective effects persisting for up to 8 months post-immunization. Importantly, the formulation was well tolerated, with no adverse effects reported. These findings demonstrate that HisDTC delivered via PLGA nanoparticles induces durable, protective immunity against L. infantum in dogs and supports its further evaluation under natural exposure conditions.
publishDate 2025
dc.date.none.fl_str_mv 2025
2026
2026
dc.type.none.fl_str_mv info:eu-repo/semantics/dataset
http://purl.org/coar/resource_type/c_ddb1
Publisher's version
info:eu-repo/semantics/publishedVersion
format dataset
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/416382
https://doi.org/10.20350/digitalCSIC/17917
url http://hdl.handle.net/10261/416382
https://doi.org/10.20350/digitalCSIC/17917
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv #PLACEHOLDER_PARENT_METADATA_VALUE#
info:eu-repo/grantAgreement/AEI/Plan Estatal de Investigación Científica y Técnica y de Innovación 2021-2023/PID2023-146579OB-I00
Hurtado-Morillas, Clara; Mas, Alicia; Orden, José A.; Urbina-Fuentes, Laura de; Blanco, María Del Mar; Domínguez-Bernal, Gustavo; Martínez-Rodrigo, Abel. Evaluation of the safety and immunogenicity of a peptide vaccine against canine leishmaniosis: a double-blind, multicenter, controlled clinical trial in dogs. https://doi.org/10.1080/01652176.2025.2591396. http://hdl.handle.net/10261/416378
https://doi.org/10.6084/m9.figshare.30796923
Sí
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instname:Consejo Superior de Investigaciones Científicas (CSIC)
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