Chimpanzee Adenovirus Vector Ebola Vaccine
| Autor: | Julie E, Ledgerwood, Adam D, DeZure, Daphne A, Stanley, Emily E, Coates, Laura, Novik, Mary E, Enama, Nina M, Berkowitz, Zonghui, Hu, Gyan, Joshi, Aurélie, Ploquin, Sandra, Sitar, Ingelise J, Gordon, Sarah A, Plummer, LaSonji A, Holman, Cynthia S, Hendel, Galina, Yamshchikov, Francois, Roman, Alfredo, Nicosia, Stefano, Colloca, Riccardo, Cortese, Robert T, Bailer, Richard M, Schwartz, Mario, Roederer, John R, Mascola, Richard A, Koup, Nancy J, Sullivan, Barney S, Graham, Sarah, Romano |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Fever Pan troglodytes T-Lymphocytes Genetic Vectors Simian Antibodies Viral medicine.disease_cause 03 medical and health sciences Animals Humans Medicine Vector (molecular biology) Ebola Vaccines Glycoproteins Ebolavirus Ebola virus Ebola vaccine biology business.industry Immunogenicity General Medicine Hemorrhagic Fever Ebola Middle Aged biology.organism_classification Antibodies Neutralizing Virology Vaccination Clinical trial 030104 developmental biology Immunology Adenoviruses Simian business |
| Zdroj: | New England Journal of Medicine. 376:928-938 |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | BackgroundThe unprecedented 2014 epidemic of Ebola virus disease (EVD) prompted an international response to accelerate the availability of a preventive vaccine. A replication-defective recombinant chimpanzee adenovirus type 3–vectored ebolavirus vaccine (cAd3-EBO), encoding the glycoprotein from Zaire and Sudan species, that offers protection in the nonhuman primate model, was rapidly advanced into phase 1 clinical evaluation. MethodsWe conducted a phase 1, dose-escalation, open-label trial of cAd3-EBO. Twenty healthy adults, in sequentially enrolled groups of 10 each, received vaccination intramuscularly in doses of 2×1010 particle units or 2×1011 particle units. Primary and secondary end points related to safety and immunogenicity were assessed throughout the first 8 weeks after vaccination; in addition, longer-term vaccine durability was assessed at 48 weeks after vaccination. ResultsIn this small study, no safety concerns were identified; however, transient fever developed within 1 day after vaccinat... |
| Databáze: | OpenAIRE |
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