Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen – Sofia ref.: 115854

ended

The overall aim of the EBOVAC programme is to assess the safety and efficacy of a novel prime boost prophylactic vaccine regimen against Ebola Virus Disease (EVD), which has been 100% effective in preclinical studies. This will be done via phase I, II and III trials carried out in the EU and in Africa, in response to the urgent public health need raised by the current Ebola epidemic. To expedite the development of the vaccine regimen, Phase II and Phase III trials will be carried out in parallel and therefore co-ordinated by two separate teams. Proposals responding to IMI2 Topic 1 will consequently be split into two parts. EBOVAC1 will address the Phase I and Phase III trials, whereas EBOVAC2 will address the Phase II trials. EBOVAC1 will establish the initial safety and immunogenicity of the proposed heterologous prime/ boost regimen of Ad26.ZEBOV and MVA-BNFilo vaccine through phase I studies conducted in the UK, the US and currently Ebola- unaffected African countries. This will be done by administering the vaccine in different sequences and at different time intervals so as to identify the shortest schedule that is immunogenic and to maximize the potential for short term efficacy in affected countries. Initiation of these trials is expected to occur between December 2014 and March 2015 and approximately 300 subjects will be enrolled. The main objective therefore of EBOVAC 2 is to provide extensive and robust data on the safety, immunogenicity and efficacy of the Ad26.ZEBOV and MVA-BN-Filo vaccine. This will be done by: 1. Carrying out translational studies to link vaccine elicited immune responses in humans to protection from Ebola in vaccinated non-human primates (via WP4) 2. Carrying out Phase II trials in African and European volunteers in 6 countries, four in Africa and two in the EU with an overall target enrolment of approximately 1,500 subjects. Given the compressed nature of this development program, the Phase II studies will be conducted in parallel