Environmental Risk Assessment for rVSVΔG-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease

被引:11
|
作者
Tell, Joan G. [1 ]
Coller, Beth-Ann G. [1 ]
Dubey, Sheri A. [1 ]
Jenal, Ursula [2 ]
Lapps, William [1 ]
Wang, Liman [1 ]
Wolf, Jayanthi [1 ]
机构
[1] Merck & Co Inc, Kenilworth, NJ 07033 USA
[2] Jenal & Partners Biosafety Consulting, CH-4310 Rheinfelden, Switzerland
关键词
ERA; rVSV; recombinant vaccine; GMO; vesicular stomatitis virus; Zaire ebolavirus; shedding; viremia; environmental impact; ERVEBO (R); VESICULAR STOMATITIS-VIRUS; NEW-JERSEY SEROTYPE; RANDOMIZED DOUBLE-BLIND; HEALTHY-ADULTS; SIERRA-LEONE; SAFETY; INFECTION; TRANSMISSION; IMMUNOGENICITY; VECTOR;
D O I
10.3390/vaccines8040779
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
rVSV Delta G-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, rVSV Delta G-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 rVSV Delta G-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 rVSV Delta G-ZEBOV-GP would spread within animal populations. Preclinical studies in various hematophagous insect vectors showed that these species were unable to transmit rVSV Delta G-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.
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页码:1 / 23
页数:23
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