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 Congo (DRC) and the recent identification of Ebola cases in the cities of Goma and Bukavu (which border Rwanda) are of particular concern and have prompted the Rwandan Government to take control measures for preventing cross- border spread of EVD. As demonstrated by the current outbreak, purely reactive measures may be insufficient to fight Ebola. Prophylactic approaches are needed that can prevent emergence of EVD in previously unaffected areas. We propose to conduct a large-scale vaccination campaign targeting 196,000 individuals living and working in border-proximate areas; a clinical trial to evaluate the immunogenicity of the AD26.ZEBOV, MVA-BN-Filo vaccine in 2,000 people; and a clinical trial to evaluate the safety of the vaccine among 2,000 pregnant women in the context of this new framework of Ebola prevention. These 3 programs will together generate a large cohort that can be revisited for a long term follow up study to assess long term immunogenicity at different times following vaccination; an evaluation of a potential effect of booster doses and the optimal strategy for booster administration; and an evaluation of long term assessment of effectiveness using a test-negative case control study design.