Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/31178
Title: Schistosomiasis vaccine candidate Sm14/GLA-SE: phase 1 safety and immunogenicity clinical trial in healthy, male adults
Authors: Santini-Oliveira, Marilia
Coler, Rhea N.
Parra, Juçara
Veloso, Valdilea
Jayashankar, Lakshmi
Pinto, Patricia M.
Ciol, Marcia A.
Bergquist, Robert
Reed, Steven G.
Tendler, Miriam
Affilliation: Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Infectious Disease Research Institute. Seattle, USA.
Fundação Oswaldo Cruz Mato Grosso do Sul. Campo Grande, MS, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Infectious Disease Research Institute. Seattle, USA.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.
University of Washington. Department of Rehabilitation Medicine. School of Medicin. Seattle, USA.
Geospatial Health. Brastad, Sweden.
Infectious Disease Research Institute. Seattle, USA.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Esquistossomose Experimental. Rio de Janeiro, RJ, Brasil.
Abstract: Safety and immunogenicity of a recombinant 14kDa, fatty acid-binding protein(FABP) from Schistosoma mansoni (rSm14) were evaluated through an open, non-placebo-controlled, dose-standardized trial, performed at a single research site. The vaccine was formulated with glucopyranosyl lipid A (GLA) adjuvant in an oil-in-water emulsion (SE) and investigated in 20 male volunteers from a non-endemic area for schistosomiasis in the state of Rio de Janeiro, Brazil. Fifty microgram rSm14 with 10 μg GLA-SE (rSm14/GLA-SE)/dose were given intramuscularly three times with 30-day intervals. Participants were assessed clinically, biochemically and immunologically for up to 120 days.
Keywords: Schistosomiasis
Recombinant vaccine
rSm14
GLA-SE
Fatty acid-binding protein (FABP)
Brazil
Phase 1 clinical trial
Issue Date: 2016
Publisher: Elsevier
Citation: SANTINI-OLIVEIRA, Marilia. Schistosomiasis vaccine candidate Sm14/GLA-SE: phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine, v. 34, p. 586-594, 2016.
DOI: 10.1016/j.vaccine.2015.10.027
ISSN: 0264-410X
Copyright: restricted access
Appears in Collections:IOC - Artigos de Periódicos
MS - Artigos de Periódicos
INI - Artigos de Periódicos

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