Volume 35, Issue 35, Part A, Pages 4451-4490 (16 August 2017)
10th Vaccine Congress
Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic
Original Research Article
Beth-Ann G. Coller, Jeffrey Blue, Rituparna Das, Sheri Dubey, Lynn Finelli, Swati Gupta, Frans Helmond, Rebecca J. Grant-Klein, Kenneth Liu, Jakub Simon, Sean Troth, Susan VanRheenen, Julie Waterbury, Ashley Wivel, Jayanthi Wolf, D. Gray Heppner, Tracy Kemp, Rick Nichols, Thomas P. Monath
The 2014–2016 Ebola outbreak caused over 28,000 cases and 11,000 deaths. Merck & Co. Inc., Kenilworth, NJ USA and NewLink Genetics are working with private and public partners to develop and license an Ebola vaccine that was evaluated extensively during the outbreak. The vaccine referred to as V920 is a recombinant vesicular stomatitis virus (rVSV) in which the VSV-G envelope glycoprotein (GP) is completely replaced by the Zaire ebolavirus GP (rVSVΔG-ZEBOV-GP). Eight Phase I and four Phase II/III clinical trials enrolling approximately 17,000 subjects were conducted in parallel to the outbreak to assess the safety, immunogenicity, and/or efficacy of V920. Immunogenicity data demonstrate that anti-GP antibodies are generally detectable by ELISA by 14 days postvaccination with up to 100% seroconversion observed by 28 days post dose. In addition, the results of a ring vaccination trial conducted by the WHO and their partners in Guinea suggest robust vaccine efficacy within 10 days of receipt of a single dose of vaccine. The vaccine is generally well-tolerated when administered to healthy, non-pregnant adults. The development of this vaccine candidate in the context of this unprecedented epidemic has involved the close cooperation of large number of international partners and highlights what we as a public health community can accomplish when working together towards a common goal.
Study identification: V920-001 to V920-012.
CLINICALTRIALS.GOV identifiers: NCT02269423; NCT02280408; NCT02374385; NCT02314923; NCT02287480; NCT02283099; NCT02296983; NCT02344407; NCT02378753; NCT02503202.