Projektbeschreibung
Erforschung und Evaluierung von Ebola-Impfstoffen vorantreiben
Ebola ist eine Viruserkrankung, die zu schweren Krankheiten führen kann und potenziell tödlich ist. Die Krankheitsausbrüche in Afrika in den Jahren 2014 bis 2018 haben die Notwendigkeit der Entwicklung von Impfstoffen unterstrichen und zum Start des IMI-Programms Ebola+ geführt, das Forschungsprojekte zum Thema Ebola finanziert. Ziel des EU-finanzierten Projekts EBOVAC2 ist es, die Sicherheit, Immunogenität und Wirksamkeit von zwei prophylaktischen Ebola-Impfstoffen anhand einer Reihe von klinischen Studien in Europa und Afrika zu prüfen. Die Sicherheit und Wirksamkeit des Zwei-Dosen-Impfschemas wird auch bei Kindern, älteren Menschen und HIV-Infizierten untersucht. Darüber hinaus werden translationale Arbeiten an nicht-menschlichen Primaten wertvolle Informationen über die zum Schutz vor Ebola erforderlichen Immunreaktionen bieten.
Ziel
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).
Wissenschaftliches Gebiet
- 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
Programm/Programme
Aufforderung zur Vorschlagseinreichung
H2020-JTI-IMI2-2014-02-single-stage
Andere Projekte für diesen Aufruf anzeigenFinanzierungsplan
IMI2-RIA - Research and Innovation actionKoordinator
75654 Paris
Frankreich