Although several promising candidate medical countermeasures are progressing through clinical development, as of now, there is no licensed vaccine available to effectively combat a potential future outbreak of Sudan virus disease (SVD) or Marburg disease (MD). Likewise, approved treatments are only available for Ebola Zaire virus (EBOV).
These filoviruses, and potentially other filoviruses and strains, continue to pose a substantial health security threat to various communities and countries across the African continent.
To be prepared for a future filovirus outbreak, robust research that helps reduce uncertainty and answers questions of public health importance is urgently needed. New approaches need to be explored to respond quicker and address implementation and operational bottlenecks.
The objectives of the workshop were to:
- Foster collaboration for evaluating filovirus candidate vaccines and therapeutics before and during outbreak responses, led by Ministries of Health and national research teams.
- Give the opportunity to national researchers and authorities to discuss existing trial protocols for candidate filovirus vaccines and therapeutics towards final consensus on key trial design attributes.
- Develop an action plan for a collaborative network of designated filovirus researchers in "at risk" countries via engagement in a framework for clinical research preparedness to ensure clinical research is promptly integrated into future outbreak plans and responses.
Presentations Day 1 (20 February, 2024)
Session 1: WHO’s Strategic Agenda for Filovirus Research and Monitoring (WHO-AFIRM)
WHO roadmap for filovirus research
Using expanded access/compassionate use to evaluate rVSV-ZEBOV-GP in DRC
Integrating vaccine research inot oubreak response
Implementing the MEURI protocol to accelerate access and collection of evidence
Experience integrating therapeutics trials as part of the outbreak response
Outline of major design considerations for candidate vaccines trial CORE protocol
Outline of major design considerations for candidate therapeutics trials CORE protocol
Process for prioritization and current recommendations for the evaluation of candidate vaccines
Process for prioritization and current recommendations for the evaluation of candidate therapeutics
Session 2: CORE filovirus clinical trial protocols that reflect country experiences and realities
Vaccine discussions, objectives and design
Therapeutics discussion, objectives and design
Therapeutics target populations (inclusion and exclusion)
Vaccines discussion, key analyses and endpoints
Presentations Day 2 (21 February, 2024)
Session 3: Addressing operational challenges of integrating clinical research during outbreaks
Setting up a MEURI to evaluate candidate therapeutics in the context of an outbreak
Setting up an RCT to evaluate candidate therapeutics in the context of an outbreak
Setting up an RCT to evaluate candidate vaccines in the context of an outbreak
Session 4: Towards the completion, review and approval of CORE filovirus protocols
AVAREF potential role in facilitating the review and pre-approval process
Session 5: Updates on essential enabling research activities
Laboratory, overview on standards, diagnostics
Community engagement during trials overview
Data Management for trials, Experience from ALERRT initiative
Data management, experience from Brazil
Session 6: The way forward to enhance collaboration and coordination. Hybrid session with the participation of Senior Officials from the countries at risk
Filovirus meeting summary for Day 2