Background
In light of the recent Rift Valley Fever (RVF) outbreak in Senegal and Mauritania, and within the framework of the Phenuiviridae Collaborative Open Research Consortium (CORC), this consultation will focus on the development of a CORE Clinical Trial Protocol for RVF Vaccine(s) during outbreaks.
This open consultation will bring together RVF experts, national representatives from affected countries, and clinical trial specialists to collaboratively design a harmonized protocol for implementing RVF vaccine trial(s) in affected regions.
This consultation follows the Urgent Scientific Consultation on Rift Valley Fever (RVF) Research Priorities held on 14 October. A recording of that session is available at the following link: Recording (Passcode: =c2I5Rrw)
Proposed objectives:
To discuss detailed design issues for consideration to move forward the evaluation of RVF using CORE protocols
Expected outputs:
- Outline of suitable primary, secondary and exploratory endpoints.
- Outline on trial designs that can be used (including alternative designs with immunological endpoints)
- Revise key research gaps to inform efficacy evaluation.
This consultation focuses primarily on study design consideration and will not include other important elements related to the implementation of clinical trials, including but not limited to logistics, operations, community engagement, funding, and training.