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AutorDiemert, David J.
AutorFreire, Janaína de Moura
AutorValente, Vanderson Firmiano
AutorFraga, Carlos Geraldo
AutorTalles, Frederico
AutorGrahek, Shannon
AutorCampbell, Doreen
AutorJariwala, Amar
AutorPeriago, Maria Victoria
AutorEnk, Martin Johannes
AutorBethony, Maria Flávia Gazzinelli
AutorBottazzi, Maria Elena
AutorHamilton, Robert
AutorBrelsford, Jill
AutorYakovleva, Anna
AutorLi, Guangzhao
AutorPeng, Jin
AutorOliveira, Rodrigo Correa de
AutorHotez, Peter Jay
AutorBethony, Jeffrey Michael
Fecha de acceso2018-05-18T16:58:59Z
Fecha de disponibilización2018-05-18T16:58:59Z
Fecha de publicación2017
ReferenciaDIEMERT, David J. et al. Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults. PLoS Negl Trop Dis., v. 11, n. 5, p. 1-22, 2017.pt_BR
ISSN1935-2727pt_BR
URIhttps://www.arca.fiocruz.br/handle/icict/26484
Idiomaengpt_BR
EditorPublic Library of Sciencept_BR
Derechos de autoropen accesspt_BR
Palabras clave en PortuguésVacinaçãopt_BR
Palabras clave en PortuguésImunizaçãopt_BR
TítuloSafety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adultspt_BR
Tipo del documentoArticlept_BR
DOI10.1371/journal.pntd.0005574
Resumen en InglésNecator americanus Glutathione-S-Transferase-1 (Na-GST-1) plays a role in the digestion of host hemoglobin by adult N. americanus hookworms. Vaccination of laboratory animals with recombinant Na-GST-1 is associated with significant protection from challenge infection. Recombinant Na-GST-1 was expressed in Pichia pastoris and adsorbed to aluminum hydroxide adjuvant (Alhydrogel) according to current Good Manufacturing Practice. Two Phase 1 trials were conducted in 142 healthy adult volunteers in the United States and Brazil, first in hookworm-naïve individuals and then in residents of a N. americanus endemic area in Brazil. Volunteers received one of three doses of recombinant Na-GST-1 (10, 30, or 100 μg) adjuvanted with Alhydrogel, adjuvanted with Alhydrogel and co-administered with an aqueous formulation of Glucopyranosyl Lipid A (GLA-AF), or the hepatitis B vaccine. Vaccinations were administered via intramuscular injection on days 0, 56, and 112. Na-GST-1/Alhydrogel was well tolerated in both hookworm-naïve and hookworm-exposed adults, with the most common adverse events being mild to moderate injection site pain and tenderness, and mild headache and nausea; no vaccine-related severe or serious adverse events were observed. Antigen-specific IgG antibodies were induced in a dose-dependent fashion, with increasing levels observed after each vaccination in both trials. The addition of GLA-AF to Na-GST-1/Alhydrogel did not result in significant increases in specific IgG responses. In both the US and Brazil studies, the predominant IgG subclass induced against Na-GST-1 was IgG1, with lesser amounts of IgG3. Vaccination of both hookworm-naïve and hookworm-exposed adults with recombinant Na-GST-1 was safe, well tolerated, and resulted in significant antigen-specific IgG responses. Based on these results, this vaccine will be advanced into clinical trials in children and eventual efficacy studies.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónUniversidade Federal de Minas Gerais. Faculdade Enfermagem. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónDepartment of Pediatrics. Section of Pediatric Tropical Medicine. Sabin Vaccine Institute and Texas Children's Hospital Center for Vaccine Development. National School of Tropical Medicine. Baylor College of Medicine. Houston, TX, USA.pt_BR
AfiliaciónJohns Hopkins University School of Medicine. Baltimore, MD, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
AfiliaciónFundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.pt_BR
AfiliaciónDepartment of Pediatrics. Section of Pediatric Tropical Medicine. Sabin Vaccine Institute and Texas Children's Hospital Center for Vaccine Development. National School of Tropical Medicine. Baylor College of Medicine. Houston, TX, USA.pt_BR
AfiliaciónDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.pt_BR
Palavras clave en InglêsVaccination and immunizationpt_BR
Palavras clave en InglêsAntibodiespt_BR
Palavras clave en InglêsHookwormspt_BR
Palavras clave en InglêsEnzyme-linked immunoassayspt_BR
Palavras clave en InglêsHepatitis Bpt_BR
Palavras clave en InglêsRecombinant vaccinespt_BR
xmlui.metadata.dc.subject.ods03 Saúde e Bem-Estar


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