Clinical Trial Readiness through the Establishment of a Pilot Filovirus Investigational Vaccine Reserve

This call for tenders aims to advance the clinical trial preparedness and readiness for Filovirus outbreaks within the European Union and globally as a critical preparedness measure, given the sporadic yet high-consequence nature of these pathogens. Specifically, the call aims to establish, pilot and maintain an investigational reserve of Filovirus candidate vaccines against Marburg (MARV) and/or Ebola Sudan (SUDV) to support such preparedness. Readiness for phase 2 and/or phase 2/3 clinical trials of Filovirus vaccines will be ensured through the advance preparation of key clinical trial activities, including the establishment of an EU-based reserve of those investigational vaccines. Subject to specific conditions being met (such as the occurrence of an outbreak and the expressed consent of the Contracting Authority), this call for tenders also provisions for the use of the reserved investigational vaccine candidates to enable clinical trials up to the number of doses held in reserve.