Clinical Trials of an Experimental Ebola Vaccine: A Canadian Research Response

This initiative supports phases 2 and 3 clinical trials of an experimental Ebola vaccine. The experimental vaccine is based on an attenuated recombinant Vesicular Stomatitis Virus vector (VSV-EBOV). The Public Health Agency of Canada developed the vaccine and licensed it to NewLink Genetics and Merck. Early vaccine trials During the multicentre phase 1 trials, researchers demonstrated the vaccine's safety and its ability to provoke an immune response (immunogenicity). The next trials will determine the expanded safety, protective immune response, and efficacy of the vaccine with at-risk populations in Africa. The trials will allow African teams to strengthen their clinical research capacities. The initiative is supported through a partnership of Foreign Affairs, Trade and Development Canada, the Canadian Institutes of Health Research, IDRC, and the Public Health Agency of Canada. Phases 2 and 3 clinical trials The phase 3 clinical trial of the VSV-EBOV vaccine will take place in Guinea, one of the main Ebola-affected countries in West Africa. An international research consortium headed by the Norwegian Institute of Public Health is leading the trials. The World Health Organization is coordinating the consortium. The clinical trial will determine the safety, protective immune response, and efficacy of the vaccine to prevent infection and the spread of the disease. Working with colleagues from Mali and Senegal, Canada will provide support for field monitoring, trial assessment, and developing Guinean clinical research capacities. The Centre hospitalier universitaire Sainte-Justine will host and chair the Data Safety Monitoring Board, an essential validating and transparency function for the vaccine trials. Canada will co-chair the Scientific Advisory Group for the Guinea Ebola vaccine trials. The partnership is discussing support for additional phase 2 clinical trials of the VSV-EBOV vaccine. These would take place in Canada and one at-risk African country not affected by the current epidemic. These trials would be performed in partnership with other donors. This will help create strong evidence of the vaccine's safety and protective immune response in broader populations, including children and HIV-positive people. Results from the project activities will be shared with the international community as part of the global response to the Ebola crisis. The results will inform the approval of the VSV-EBOV vaccine for future use to prevent Ebola transmission.