Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women

Detalhes bibliográficos
Autor(a) principal: Oliveira, Marília Santini
Data de Publicação: 2022
Outros Autores: Pinto, Patrícia Machado, Santos, Tatiane dos, Vilar, Mônica Magno, Grinsztejn, Beatriz, Veloso, Valdiléa G., Almeida, Elan C. Paes de, Amaral, Maria A. Z., Ramos, Celso R., Marroquin-Quelopana, Miryam, Coler, Rhea, Reed, Steven, Ciol, Marcia A., Savino, Wilson, Parra, Juçara de Carvalho, Almeida, Marília Sirianni dos Santos, Tendler, Miriam
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/56187
Resumo: Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
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spelling Oliveira, Marília SantiniPinto, Patrícia MachadoSantos, Tatiane dosVilar, Mônica MagnoGrinsztejn, BeatrizVeloso, Valdiléa G.Almeida, Elan C. Paes deAmaral, Maria A. Z.Ramos, Celso R.Marroquin-Quelopana, MiryamColer, RheaReed, StevenCiol, Marcia A.Savino, WilsonParra, Juçara de CarvalhoAlmeida, Marília Sirianni dos SantosTendler, Miriam2022-12-23T14:13:47Z2022-12-23T14:13:47Z2022OLIVEIRA, Marília Santini et al. Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women. Vaccines, v. 10, 1724, p. 1-15, Oct. 2022.2076-393Xhttps://www.arca.fiocruz.br/handle/icict/5618710.3390/vaccines10101724engMDPIVacinaEsquistossomoseEnsaio clínico de Fase IbToxicologiaCoelhas grávidasProteína Sm14VaccineSchistosomiasisPhase Ib clinical trialToxicologyPregnant rabbitsSm14 proteinDevelopment of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Womeninfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Universidade Federal Fluminense. Departamento de Ciências Básicas. Nova Friburgo, RJ, Brasil.Fundação Oswaldo Cruz. Fiocruz Mata Atlântica. Programa para o Desenvolvimento do Campus da Mata Atlântica. Rio de Janeiro, RJ, Brasil.Fenix Biotec Treinamento SS LTDA. São Paulo, SP, Brasil.Fenix Biotec Treinamento SS LTDA. São Paulo, SP, Brasil.University of Washington. Department of Global Health. Seatle, WA, USA.HDT Bio, Seattle, WA 98102, USA.Department of Rehabilitation Medicine, School of Medicine, University of Washington, Seattle, WA 98105, USA.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Pesquisa sobre o Timo. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Instituto Nacional de Ciência e Tecnologia de Neuroimunomodulação. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.We report the successful closure of Phase I clinical trials, comprising Phases Ia and Ib, of the vaccine candidate against human schistosomiasis: the Schistosoma mansoni 14 kDa fatty acid-binding protein (Sm14) + glucopyranosyl lipid A in squalene emulsion (GLA-SE). Shown here are the results of Phase Ib, an open, non-placebo-controlled, standardized-dose immunization trial involving 10 healthy 18–49-year-old women. Fifty micrograms of the Sm14 protein plus 10 g GLA-SE per dose was given intramuscularly thrice at 30-day intervals. Participants were assessed clinically, biochemically, and immunologically for up to 120 days. In preambular experiments involving vaccinated pregnant female rabbits, we did not find any toxicological features in either the offspring or mothers, and the vaccine induced adaptive immunity in the animals. In women, no adverse events were observed, and vaccination induced high titers of anti-Sm14 serum IgG antibody production. Vaccination also elicited robust cytokine responses, with increased TNF , IFN , and IL-2 profiles in all vaccinees on days 90 and 120. The completion of Phase I clinical trials, which were performed to the highest standards set by Good Clinical Research Practice (GCP) standards, and preclinical data in pregnant rabbits enabled the vaccine candidate to proceed to Phase II clinical trials in endemic areas.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALMariliaOliveira_WilsonSavino_etal_IOC_2022.pdfMariliaOliveira_WilsonSavino_etal_IOC_2022.pdfapplication/pdf1708822https://www.arca.fiocruz.br/bitstream/icict/56187/2/MariliaOliveira_WilsonSavino_etal_IOC_2022.pdf5a67c398d3ea7b3142d81f1a08deb4c6MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56187/1/license.txt5a560609d32a3863062d77ff32785d58MD51icict/561872023-09-04 11:03:14.083oai:www.arca.fiocruz.br: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ório 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dc.title.en_US.fl_str_mv Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
title Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
spellingShingle Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
Oliveira, Marília Santini
Vacina
Esquistossomose
Ensaio clínico de Fase Ib
Toxicologia
Coelhas grávidas
Proteína Sm14
Vaccine
Schistosomiasis
Phase Ib clinical trial
Toxicology
Pregnant rabbits
Sm14 protein
title_short Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
title_full Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
title_fullStr Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
title_full_unstemmed Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
title_sort Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women
author Oliveira, Marília Santini
author_facet Oliveira, Marília Santini
Pinto, Patrícia Machado
Santos, Tatiane dos
Vilar, Mônica Magno
Grinsztejn, Beatriz
Veloso, Valdiléa G.
Almeida, Elan C. Paes de
Amaral, Maria A. Z.
Ramos, Celso R.
Marroquin-Quelopana, Miryam
Coler, Rhea
Reed, Steven
Ciol, Marcia A.
Savino, Wilson
Parra, Juçara de Carvalho
Almeida, Marília Sirianni dos Santos
Tendler, Miriam
author_role author
author2 Pinto, Patrícia Machado
Santos, Tatiane dos
Vilar, Mônica Magno
Grinsztejn, Beatriz
Veloso, Valdiléa G.
Almeida, Elan C. Paes de
Amaral, Maria A. Z.
Ramos, Celso R.
Marroquin-Quelopana, Miryam
Coler, Rhea
Reed, Steven
Ciol, Marcia A.
Savino, Wilson
Parra, Juçara de Carvalho
Almeida, Marília Sirianni dos Santos
Tendler, Miriam
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Oliveira, Marília Santini
Pinto, Patrícia Machado
Santos, Tatiane dos
Vilar, Mônica Magno
Grinsztejn, Beatriz
Veloso, Valdiléa G.
Almeida, Elan C. Paes de
Amaral, Maria A. Z.
Ramos, Celso R.
Marroquin-Quelopana, Miryam
Coler, Rhea
Reed, Steven
Ciol, Marcia A.
Savino, Wilson
Parra, Juçara de Carvalho
Almeida, Marília Sirianni dos Santos
Tendler, Miriam
dc.subject.other.en_US.fl_str_mv Vacina
Esquistossomose
Ensaio clínico de Fase Ib
Toxicologia
Coelhas grávidas
Proteína Sm14
topic Vacina
Esquistossomose
Ensaio clínico de Fase Ib
Toxicologia
Coelhas grávidas
Proteína Sm14
Vaccine
Schistosomiasis
Phase Ib clinical trial
Toxicology
Pregnant rabbits
Sm14 protein
dc.subject.en.en_US.fl_str_mv Vaccine
Schistosomiasis
Phase Ib clinical trial
Toxicology
Pregnant rabbits
Sm14 protein
description Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
publishDate 2022
dc.date.accessioned.fl_str_mv 2022-12-23T14:13:47Z
dc.date.available.fl_str_mv 2022-12-23T14:13:47Z
dc.date.issued.fl_str_mv 2022
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 OLIVEIRA, Marília Santini et al. Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women. Vaccines, v. 10, 1724, p. 1-15, Oct. 2022.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/56187
dc.identifier.issn.en_US.fl_str_mv 2076-393X
dc.identifier.doi.none.fl_str_mv 10.3390/vaccines10101724
identifier_str_mv OLIVEIRA, Marília Santini et al. Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized- Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women. Vaccines, v. 10, 1724, p. 1-15, Oct. 2022.
2076-393X
10.3390/vaccines10101724
url https://www.arca.fiocruz.br/handle/icict/56187
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)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/56187/2/MariliaOliveira_WilsonSavino_etal_IOC_2022.pdf
https://www.arca.fiocruz.br/bitstream/icict/56187/1/license.txt
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
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