Project description DEENESFRITPL Novel prophylactic vaccines against Ebola virus disease The overall goal of the EBOVAC programme is to conduct all phases of clinical studies to assess the safety and efficacy of a novel prime-boost prophylactic Ad26.ZEBOV and MVA-BNFilo vaccines against Ebola virus disease (EVD). The expedited development of the vaccine regimen requires that phase II and phase III trials be conducted in parallel by separate teams. The EU-funded EBOVAC1 project will address both phase I and phase III trials. The initial safety and immunogenicity of the proposed boost regimen will be assessed in phase I studies by administering the vaccines in different sequences at different time intervals to identify the shortest immunogenic schedule that maximises the potential for efficacy in EVD-affected countries. Show the project objective Hide the project objective Objective 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 Fields of science natural sciencesbiological scienceszoologymammalogyprimatologymedical and health scienceshealth sciencespublic healthmedical and health sciencesbasic medicineimmunologyimmunisationmedical and health scienceshealth sciencesinfectious diseasesRNA virusesebolamedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines Keywords Heterologous boost prime Ebola vaccine clinical development Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Topic(s) IMI2-2014-02-01 - Vaccine development Phase I, II, and III Call for proposal H2020-JTI-IMI2-2014-02-single-stage See other projects for this call Funding Scheme RIA - Research and Innovation action Coordinator LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER Net EU contribution € 47 208 317,53 Address KEPPEL STREET WC1E 7HT London United Kingdom See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 47 208 317,53 Participants (6) Sort alphabetically Sort by Net EU contribution Expand all Collapse all JANSSEN VACCINES & PREVENTION BV Netherlands Net EU contribution € 0,00 Address ARCHIMEDESWEG 4 2333 CN Leiden See on map Region West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 39 707 803,00 THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD United Kingdom Net EU contribution € 1 376 981,12 Address WELLINGTON SQUARE UNIVERSITY OFFICES OX1 2JD Oxford See on map Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 376 981,12 INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE France Net EU contribution € 573 722,66 Address RUE DE TOLBIAC 101 75654 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 653 722,66 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. UNIVERSITE DE BORDEAUX France Net EU contribution € 45 000,00 Address PLACE PEY BERLAND 35 33000 Bordeaux See on map Region Nouvelle-Aquitaine Aquitaine Gironde Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 45 000,00 Third-party Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure. CHU HOPITAUX DE BORDEAUX France Net EU contribution € 35 000,00 Address RUE DUBERNAT 12 33404 Talence See on map Region Nouvelle-Aquitaine Aquitaine Gironde Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 35 000,00 UNIVERSITY OF SIERRA LEONE Sierra Leone Net EU contribution € 9 097 863,69 Address COLLEGE OF MEDECINE & ALLIED HEALTH SCIENCES UNIVERSITY OF SIERRA LEONE NEW ENGLAND Freetown See on map Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 9 097 863,69
