Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults
| Autor(a) principal: | |
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| Data de Publicação: | 2017 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/26484 |
Resumo: | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA. |
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Diemert, David J.Freire, Janaína de MouraValente, Vanderson FirmianoFraga, Carlos GeraldoTalles, FredericoGrahek, ShannonCampbell, DoreenJariwala, AmarPeriago, Maria VictoriaEnk, Martin JohannesBethony, Maria Flávia GazzinelliBottazzi, Maria ElenaHamilton, RobertBrelsford, JillYakovleva, AnnaLi, GuangzhaoPeng, JinOliveira, Rodrigo Correa deHotez, Peter JayBethony, Jeffrey Michael2018-05-18T16:58:59Z2018-05-18T16:58:59Z2017DIEMERT, 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, 2017.1935-2727https://www.arca.fiocruz.br/handle/icict/2648410.1371/journal.pntd.0005574engPublic Library of ScienceVacinaçãoImunizaçãoVaccination and immunizationAntibodiesHookwormsEnzyme-linked immunoassaysHepatitis BRecombinant vaccinesSafety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adultsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleDepartment of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Universidade Federal de Minas Gerais. Faculdade Enfermagem. Belo Horizonte, MG, Brasil.Department 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.Johns Hopkins University School of Medicine. Baltimore, MD, USA.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Department 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.Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA.Necator 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.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83082https://www.arca.fiocruz.br/bitstream/icict/26484/1/license.txt9193a7c197bc67acd023525e72a03240MD51ORIGINALSafety and immunogenicity.pdfSafety and immunogenicity.pdfapplication/pdf4141075https://www.arca.fiocruz.br/bitstream/icict/26484/2/Safety%20and%20immunogenicity.pdf92a02afd3158e59e3d3051f4b1d5b59cMD52TEXTSafety and immunogenicity.pdf.txtSafety and immunogenicity.pdf.txtExtracted texttext/plain72494https://www.arca.fiocruz.br/bitstream/icict/26484/3/Safety%20and%20immunogenicity.pdf.txte99f9b8a81a8cc959113f159c19163adMD53icict/264842019-12-23 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| dc.title.pt_BR.fl_str_mv |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| title |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| spellingShingle |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults Diemert, David J. Vacinação Imunização Vaccination and immunization Antibodies Hookworms Enzyme-linked immunoassays Hepatitis B Recombinant vaccines |
| title_short |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| title_full |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| title_fullStr |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| title_full_unstemmed |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| title_sort |
Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults |
| author |
Diemert, David J. |
| author_facet |
Diemert, David J. Freire, Janaína de Moura Valente, Vanderson Firmiano Fraga, Carlos Geraldo Talles, Frederico Grahek, Shannon Campbell, Doreen Jariwala, Amar Periago, Maria Victoria Enk, Martin Johannes Bethony, Maria Flávia Gazzinelli Bottazzi, Maria Elena Hamilton, Robert Brelsford, Jill Yakovleva, Anna Li, Guangzhao Peng, Jin Oliveira, Rodrigo Correa de Hotez, Peter Jay Bethony, Jeffrey Michael |
| author_role |
author |
| author2 |
Freire, Janaína de Moura Valente, Vanderson Firmiano Fraga, Carlos Geraldo Talles, Frederico Grahek, Shannon Campbell, Doreen Jariwala, Amar Periago, Maria Victoria Enk, Martin Johannes Bethony, Maria Flávia Gazzinelli Bottazzi, Maria Elena Hamilton, Robert Brelsford, Jill Yakovleva, Anna Li, Guangzhao Peng, Jin Oliveira, Rodrigo Correa de Hotez, Peter Jay Bethony, Jeffrey Michael |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Diemert, David J. Freire, Janaína de Moura Valente, Vanderson Firmiano Fraga, Carlos Geraldo Talles, Frederico Grahek, Shannon Campbell, Doreen Jariwala, Amar Periago, Maria Victoria Enk, Martin Johannes Bethony, Maria Flávia Gazzinelli Bottazzi, Maria Elena Hamilton, Robert Brelsford, Jill Yakovleva, Anna Li, Guangzhao Peng, Jin Oliveira, Rodrigo Correa de Hotez, Peter Jay Bethony, Jeffrey Michael |
| dc.subject.other.pt_BR.fl_str_mv |
Vacinação Imunização |
| topic |
Vacinação Imunização Vaccination and immunization Antibodies Hookworms Enzyme-linked immunoassays Hepatitis B Recombinant vaccines |
| dc.subject.en.pt_BR.fl_str_mv |
Vaccination and immunization Antibodies Hookworms Enzyme-linked immunoassays Hepatitis B Recombinant vaccines |
| description |
Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA. |
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2017 |
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2017 |
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2018-05-18T16:58:59Z |
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2018-05-18T16:58:59Z |
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DIEMERT, 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. |
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https://www.arca.fiocruz.br/handle/icict/26484 |
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1935-2727 |
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10.1371/journal.pntd.0005574 |
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DIEMERT, 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. 1935-2727 10.1371/journal.pntd.0005574 |
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