| Author | Santini-Oliveira, Marília | |
| Author | Pinto, Patrícia Machado | |
| Author | Santos, Tatiane | |
| Author | Vilar, Mônica Magno | |
| Author | Grinsztejn, Beatriz | |
| Author | Veloso, Valdiléa G. | |
| Author | Paes-de-Almeida, Elan C. | |
| Author | Amaral, Maria A. Z. | |
| Author | Ramos, Celso R. | |
| Author | Marroquin-Quelopana, Miryam | |
| Author | Coler, Rhea | |
| Author | Reed, Steven | |
| Author | Ciol, Marcia A. | |
| Author | Savino, Wilson | |
| Author | Parra, Juçara de Carvalho | |
| Author | Almeida, Marília Sirianni dos Santos | |
| Access date | 2023-01-09T15:08:28Z | |
| Available date | 2023-01-09T15:08:28Z | |
| Document date | 2022 | |
| Citation | SANTINI-OLIVEIRA, Marília 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, n. 10, p. 1-15, 2022. | en_US |
| ISSN | 2076-393X | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/56396 | |
| Language | eng | en_US |
| Publisher | MDPI | en_US |
| Rights | open access | |
| 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 | en_US |
| Type | Article | |
| DOI | 10.3390/vaccines10101724 | |
| Abstract | 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 µg 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 TNFα, IFNγ, 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. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fluminense Federal University. Department of Basic Sciences. Nova Friburgo, RJ, Brazil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Programa de Desenvolvimento do Campus Mata Atlântica. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fenix Biotec Treinamento S.S. LTDA, São Paulo, SP, Brasil. | en_US |
| Affilliation | Fenix Biotec Treinamento S.S. LTDA, São Paulo, SP, Brasil. | en_US |
| Affilliation | University of Washington. Department of Global Health. Seattle, WA, USA. | en_US |
| Affilliation | HDT Bio. Seattle, WA, USA. | en_US |
| Affilliation | University of Washington. School of Medicine. Department of Rehabilitation Medicine. Seattle, WA, USA. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Pesquisa do 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. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil. | en_US |
| Subject | Sm14 Protein | en_US |
| Subject | Phase Ib Clinical Trial | en_US |
| Subject | Pregnant Rabbits | en_US |
| Subject | Schistosomiasis | en_US |
| Subject | Toxicology | en_US |
| Subject | Vaccine | en_US |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
