Environmental Risk Assessment for rVSVΔG-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease
| Autor: | Jayanthi J. Wolf, Liman Wang, Sheri Dubey, Beth-Ann Coller, Ursula Jenal, Joan Tell, William Lapps |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Zaire ebolavirus Immunology lcsh:Medicine Viremia Review Disease medicine.disease_cause environmental impact shedding 03 medical and health sciences Animal data 0302 clinical medicine recombinant vaccine ERVEBO® Drug Discovery rVSV Medicine Pharmacology (medical) 030212 general & internal medicine Pharmacology viremia Ebola virus Attenuated vaccine biology GMO business.industry lcsh:R medicine.disease biology.organism_classification Virology ERA Genetically modified organism 030104 developmental biology Infectious Diseases Vesicular stomatitis virus vesicular stomatitis virus business |
| Zdroj: | Vaccines Vaccines, Vol 8, Iss 779, p 779 (2020) |
| ISSN: | 2076-393X |
| Popis: | rVSVΔG-ZEBOV-GP is a live, attenuated, recombinant vesicular stomatitis virus (rVSV)-based vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus. As a replication-competent genetically modified organism, rVSVΔG-ZEBOV-GP underwent various environmental evaluations prior to approval, the most in-depth being the environmental risk assessment (ERA) required by the European Medicines Agency. This ERA, as well as the underlying methodology used to arrive at a sound conclusion about the environmental risks of rVSVΔG-ZEBOV-GP, are described in this review. Clinical data from vaccinated adults demonstrated only infrequent, low-level shedding and transient, low-level viremia, indicating a low person-to-person infection risk. Animal data suggest that it is highly unlikely that vaccinated individuals would infect animals with recombinant virus vaccine or that rVSVΔG-ZEBOV-GP would spread within animal populations. Preclinical studies in various hematophagous insect vectors showed that these species were unable to transmit rVSVΔG-ZEBOV-GP. Pathogenicity risk in humans and animals was found to be low, based on clinical and preclinical data. The overall risk for non-vaccinated individuals and the environment is thus negligible and can be minimized further through defined mitigation strategies. This ERA and the experience gained are relevant to developing other rVSV-based vaccines, including candidates under investigation for prevention of COVID-19. |
| Databáze: | OpenAIRE |
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