Description du projet
Nouveaux vaccins prophylactiques contre la maladie à virus Ebola
L’objectif global du programme EBOVAC est de mener toutes les phases des études cliniques afin d’évaluer la sécurité et l’efficacité d’un nouveau vaccin prophylactique prime-boost Ad26.ZEBOV et MVA-BNFilo contre la maladie à virus Ebola (MVE). Le développement accéléré du schéma vaccinal exige que les essais de phase II et de phase III soient menés en parallèle par des équipes distinctes. Le projet EBOVAC1, financé par l’UE, portera sur les essais de phase I et de phase III. La sécurité et l’immunogénicité initiales du schéma de renforcement proposé seront évaluées dans les études de phase I en administrant les vaccins dans différentes séquences à différents intervalles de temps, afin d’identifier le schéma immunogène le plus court qui maximise le potentiel d’efficacité dans les pays touchés par la MVE.
Objectif
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
Champ scientifique
Not validated
Not validated
- natural sciencesbiological scienceszoologymammalogyprimatology
- medical and health scienceshealth sciencespublic health
- medical and health sciencesbasic medicineimmunologyimmunisation
- medical and health scienceshealth sciencesinfectious diseasesRNA virusesebola
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
Programme(s)
Régime de financement
RIA - Research and Innovation actionCoordinateur
WC1E 7HT London
Royaume-Uni