Date: 12 January, 2023
Time: 14:00 to 18:30 CET
On 20 September 2022, Uganda declared an outbreak of Sudan ebolavirus, after the confirmation of a case in Mubende district in the central part of the country. Responding to this outbreak, the WHO convened emergency meetings to prioritize candidate vaccines[1]. In coordination with Ugandan researchers, health authorities, and regulators, a ring vaccination protocol was developed and locally approved [2]. Currently, Makerere University is ready to conduct a trial if new cases are confirmed and doses of the three candidate vaccines are currently available.
We organized an expert consultation on 12 January, 2023 (14:00-18:30 CET) to discuss What additional research should be conducted to advance the evaluation of these vaccines?
Any questions and design options considered should clearly contribute to advance vaccine evaluation and have a clear potential in support of public health policies. Some of the scientific questions included:
- What research questions and study designs?
- Can one or more of the vaccines be authorized using immunogenicity data and if yes what kind of data should be generated?
- What other studies are needed to advance the evaluation and licensure of these vaccines?
- What are the regulatory pathways for licensure for each candidate if clinical data cannot be generated?
PRESENTATIONS
- Objectives of the meeting
- Sudan ebolavirus epidemiology
- A trial to evaluate the efficacy and safety of Sudan ebolavirus vaccines in Uganda – Solidarity against Ebola/Tokomeza Ebola
- Vaccine research integrated in the response to the outbreak in Uganda
Session 1. What are the knowledge gaps and what study designs could address them?
- IAVI Vesicular Stomatitis Virus Sudan Virus Vaccine (VSV-SUDV) Program Update
- Sabin ChAd3 Sudan Vaccine
- An overview of ChAdOx1 biEBOV - planned/ongoing clinical studies
- What other study designs should be considered?
- A multi-way trial to assess safety and immunogenicity
- How could vaccine studies among contacts of survivors contribute?
- What studies should be considered to advance the evaluation of these candidate vaccines and further define prioritization among them?
Session 2. Can efficacy of one or more of the vaccines be demonstrated without clinical endpoint efficacy studies and, if yes, what kind of data should be generated?
- Bridging animal and human data in pursuit of vaccine authorization
- Considerations for immunobridging in evaluation of Sudan ebolavirus vaccines
Session 3. What are the potential pathways for regulatory authorization for each candidate?
RESOURCES:
