| Author | Brelsford, Jill B. | |
| Author | Plieskatt, Jordan L. | |
| Author | Yakovleva, Anna | |
| Author | Jariwala, Amar | |
| Author | Keegan, Brian P. | |
| Author | Peng, Jin | |
| Author | Xia, Pengjun | |
| Author | Li, Guangzhao | |
| Author | Campbell, Doreen | |
| Author | Periago, Maria Victoria | |
| Author | Oliveira, Rodrigo Correa de | |
| Author | Bottazzi, Maria Elena | |
| Author | Hotez, Peter J. | |
| Author | Diemert, David | |
| Author | Bethony, Jeffrey Michael | |
| Access date | 2018-06-05T16:50:08Z | |
| Available date | 2018-06-05T16:50:08Z | |
| Document date | 2017 | |
| Citation | BRELSFORD, Jill B et al. Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine. PLoS Neglected Tropical Diseases, v. 11, n. 2, p. 1-19, 2017. | pt_BR |
| ISSN | 1935-2727 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/26733 | |
| Language | eng | pt_BR |
| Publisher | Public Library of Science | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | Vacinas | pt_BR |
| Subject in Portuguese | Desenvolvimento de vacinas | pt_BR |
| Title | Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1371/journal.pntd.0005385 | |
| Abstract | A new generation of vaccines for the neglected tropical diseases (NTDs) have now advanced into clinical development, with the Na-GST-1/Alhydrogel Hookworm Vaccine already being tested in Phase 1 studies in healthy adults. The current manuscript focuses on the often overlooked critical aspects of NTD vaccine product development, more specifically, vaccine stability testing programs. A key measure of vaccine stability testing is "relative potency" or the immunogenicity of the vaccine during storage. As with most NTD vaccines, the Na-GST-1/Alhydrogel Hookworm Vaccine was not developed by attenuation or inactivation of the pathogen (Necator americanus), so conventional methods for measuring relative potency are not relevant for this investigational product. Herein, we describe a novel relative potency testing program and report for the first time on the clinical lot of this NTD vaccine during its first 60 months of storage at 2–8°C. We also describe the development of a complementary functional assay that measures the ability of IgG from animals or humans immunized with Na-GST-1/Alhydrogel to neutralize this important hookworm enzyme. While 90% inhibition of the catalytic activity of Na-GST-1 was achieved in animals immunized with Na-GST-1/Alhydrogel, lower levels of inhibition were observed in immunized humans. Moreover, anti-Na-GST-1 antibodies from volunteers in non-hookworm endemic areas were better able to inhibit catalytic activity than anti-Na-GST-1 antibodies from volunteers resident in hookworm endemic areas. The results described herein provide the critical tools for the product development of NTD | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA. | pt_BR |
| Affilliation | Department of Pathology. School of Medicine and Health Sciences. The George Washington University. Washington DC, USA. | pt_BR |
| Affilliation | Department of Pediatrics. Section of Pediatric Tropical Medicine. Sabin Vaccine Institute and Texas Children's Hospital Center for Vaccine Development. Baylor College of Medicine. Houston, TX, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. George Washington University.Washington DC, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. George Washington University.Washington DC, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. George Washington University.Washington DC, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. George Washington University.Washington DC, USA. | pt_BR |
| Affilliation | Fundación Mundo Sano. Buenos Aires, Argentina. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil. | pt_BR |
| Affilliation | Department of Pathology, School of Medicine and Health Sciences. George Washington University. Washington DC, USA / National School of Tropical Medicine, Baylor College of Medicine. Houston, TX, USA. | pt_BR |
| Affilliation | Department of Pathology, School of Medicine and Health Sciences. George Washington University. Washington DC, USA / National School of Tropical Medicine, Baylor College of Medicine. Houston, TX, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. George Washington University.Washington DC, USA. | pt_BR |
| Affilliation | Department of Microbiology, Immunology and Tropical Medicine. School of Medicine and Health Sciences. George Washington University.Washington DC, USA. | pt_BR |
| Subject | Vaccines | pt_BR |
| Subject | Vaccine development | pt_BR |
| Subject | Hookworms | pt_BR |
| Subject | Antibodies | pt_BR |
| Subject | Blood plasma | pt_BR |
| Subject | Neglected tropical diseases | pt_BR |
| Subject | Recombinant vaccines | pt_BR |
| Subject | Desorption | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
