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| Autor | Bethony, Jeffrey Michael | |
| Autor | Simon, Gary | |
| Autor | Diemert, David J. | |
| Autor | Parenti, David | |
| Autor | Desrosiers, Aimee | |
| Autor | Schuck, Suzanne | |
| Autor | Fujiwara, Ricardo | |
| Autor | Santiago, Helton | |
| Autor | Hotez, Peter J. | |
| Fecha de acceso | 2021-12-28T12:50:54Z | |
| Fecha de disponibilización | 2021-12-28T12:50:54Z | |
| Fecha de publicación | 2008 | |
| Referencia | BETHONY, Jeffrey Michael et al. Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults Vaccine, v. 26, n. 19, p. 2408-2417, 2008 | pt_BR |
| ISSN | 0264-410X | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/50533 | |
| Idioma | eng | pt_BR |
| Editor | Elsevier | pt_BR |
| Derechos de autor | restricted access | pt_BR |
| Título | Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 Hookworm Vaccine in unexposed adults | pt_BR |
| Tipo del documento | Article | |
| DOI | 10.1016/j.vaccine.2008.02.049 | |
| Resumen en Inglés | Necator americanus Ancylostoma Secreted Protein-2 (Na-ASP-2) is a leading larval-stage hookworm vaccine candidate. Recombinant Na-ASP-2 was expressed in Pichia pastoris and formulated with Alhydrogel (R). In a phase 1 trial, 36 healthy adults without history of hookworm infection were enrolled into 1 of 3 dose cohorts (n = 12 per cohort) and randomized to receive intramuscular injections of either Na-ASP-2 or saline placebo. Nine participants in the first, second and third cohorts were assigned to receive 10, 50 and 100 mu g of Na-ASP-2, respectively, on study days 0, 56 and 112, while 3 participants in each cohort received placebo. The most frequent adverse events were mild-to-moderate injection site reactions; in 8 participants these were delayed and occurred up to 10 days after immunization. No serious adverse events occurred. Anti-Na-ASP-2 IgG endpoint titers as determined by ELISA increased from baseline in all. vaccine groups and peaked 14 days after the third injection, with geometric mean titers of 1:7066, 1:7611 and 1:11,593 for the 10, 50 and 100 mu g doses, respectively, compared to <1: 100 for saline controls (p < 0.001). Antibody titers remained significantly elevated in all. vaccine groups until the end of the study, approximately 8 months after the third vaccination. In vitro stimulation of PBMCs collected from participants with Na-ASP-2 resulted in robust proliferative responses in those who received vaccine, which increased with successive immunizations and remained high in the 50 and 100[mu g dose groups through the end of the study. This first trial of a human hookworm vaccine demonstrates that the Na-ASP-2 vaccine is well-tolerated and induces a prolonged immune response in adults not exposed to hookworm, justifying further testing of this vaccine in an endemic area. (C) 2008 Elsevier Ltd. All rights reserved | pt_BR |
| Afiliación | Department of Microbiology, Immunology and Tropical Medicine. George Washington University Health Center. Washington, DC, United States | pt_BR |
| Afiliación | Department of Medicine. George Washington University Health Center. Washington, DC, United States | pt_BR |
| Afiliación | Department of Microbiology, Immunology and Tropical Medicine. George Washington University Health Center. Washington, DC, United States/Albert B. Sabin Vaccine Institute. Washington, DC, United States | pt_BR |
| Afiliación | Department of Medicine. George Washington University Health Center. Washington, DC, United States | pt_BR |
| Afiliación | Department of Medicine. George Washington University Health Center. Washington, DC, United States | pt_BR |
| Afiliación | Department of Medicine. George Washington University Health Center. Washington, DC, United States | pt_BR |
| Afiliación | Fundação Oswaldo Cruz.Instituto René Rachou. Belo Horizonte, MG, Brazil | pt_BR |
| Afiliación | Department of Microbiology, Immunology and Tropical Medicine. George Washington University Health Center. Washington, DC, United States | pt_BR |
| Afiliación | Department of Microbiology, Immunology and Tropical Medicine. George Washington University Health Center. Washington, DC, United States/Albert B. Sabin Vaccine Institute. Washington, DC, United States | pt_BR |
| Palavras clave en Inglês | phase 1 | pt_BR |
| Palavras clave en Inglês | hookworm | pt_BR |
| Palavras clave en Inglês | nematode | pt_BR |
| Palavras clave en Inglês | recombinant vaccine | pt_BR |
| Fecha de embargo | 2024-12-31 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar |
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