Description du projet
Faire progresser la recherche et l’évaluation d’un vaccin contre le virus Ebola
Ebola est une maladie virale qui peut provoquer une maladie grave et s’avérer mortelle. Les épidémies de 2014 à 2018 en Afrique ont souligné l’urgence de développer un vaccin et initié le lancement du programme IMI Ebola+, qui a financé des projets de recherche sur le virus Ebola. Le projet EBOVAC2, financé par l’UE, entend tester l’innocuité, l’immunogénicité et l’efficacité de deux vaccins prophylactiques contre le virus Ebola dans le cadre de divers essais cliniques menés en Europe et en Afrique. La sécurité et l’efficacité du schéma vaccinal à deux doses seront également évaluées chez les enfants, les personnes âgées et les personnes porteuses du VIH. En outre, les travaux de transposition chez les primates non humains fourniront de précieuses informations sur les réponses immunitaires nécessaires à la protection contre le virus Ebola.
Objectif
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 with the planned Phase III study (EBOVAC1). The phase II studies will be placebo-controlled and will be conducted in locations where it is possible to perform carefully controlled safety studies (via WP2).
3. Evaluating the use of the vaccine in special population groups, such as children (ages 1-17 years), the elderly (ages 50-65) and individuals infected with HIV, to confirm safety and immunogenicity.
It is intended that Phase II trials will begin as soon as safety data are available from Phase I trials (via WP2).
4. Monitoring and characterising immune response to the proposed vaccine (via WP3).
5. Boosting the capacity of African centres, staff and infrastructure in preparation for Phase III studies and communicating and disseminating widely the results of EBOVAC2 as they become available to all key stakeholders (via WP6).
6. Contributing all data to the Central Information Repository for use by other Ebola programme projects as well as the wider community (via WP5).
Champ scientifique
- natural sciencesbiological scienceszoologymammalogyprimatology
- medical and health scienceshealth sciencesinfectious diseasesRNA virusesebola
- medical and health sciencesbasic medicineimmunology
- medical and health scienceshealth sciencesinfectious diseasesRNA virusesHIV
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
Programme(s)
Régime de financement
IMI2-RIA - Research and Innovation actionCoordinateur
75654 Paris
France