UMURINZI - Unprecedented Movement to drive a Unified Rwandan Initiative for National ZEBOVAC Immunization

The ongoing outbreak of Ebola Virus Disease (EVD) in the Democratic Republic of Republic of the Congo (DRC) is of particular concern for the Government of Rwanda, when one considers the high population density of Rwanda and the number of people crossing the border between Rwanda and DRC on a daily basis. Janssen Vaccines and Prevention B. V. (Janssen) and the Rwanda Ministry of Health have recently entered into an agreement for a donation of 200,000 doses of the Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine. Rwanda FDA has granted conditional approval of the vaccine under exceptional emergency circumstances in accordance with SAGE recommendations to "put in place approvals for investigational medicines and vaccines as an immediate priority for preparedness". This Ebola vaccine initiative consists of: 1) a mass vaccination campaign that will target up to 193,000 individuals crossing or living in sectors/districts sharing the border with DRC; this program is known as UMURINZI (Unprecedented Movement to drive a Unified Rwandan Initiative for National ZEBOVAC Immunization); 2) a clinical trial to evaluate the immunogenicity of the vaccine regimen in 2,000 people; 3) and a clinical trial to evaluate the safety of the vaccine among 5,000 pregnant women. This proposal concerns start up of UMURINZI only.