Imagine a virus that mostly hits livestock but can jump to humans, causing severe bleeding and high death rates. This project is like a high-speed training camp for new vaccines to stop this virus from spreading. It's moving from lab tests to real-world trials in areas where the virus is most common to ensure the medicine actually works.
Rift Valley fever causes high livestock mortality and up to 50% human fatality. Climate change is increasing the risk of these outbreaks spreading into new regions, including Europe, creating an urgent need for scalable, approved vaccines.
GMP batches of DDvax and hRVFV-4s vaccines, a transferred manufacturing process, and a Phase IIa clinical trial protocol.
If you are a vaccine manufacturer dealing with the need for new epidemic-ready products — this project developed GMP batches of DDvax and hRVFV-4s manufacturing processes that reduce the risk of early-stage development failure.
If you are an animal health company dealing with livestock losses from viral hemorrhagic diseases — this project developed a One Health approach and merged animal-human data repositories to improve cross-species vaccine efficacy.
If you are a health agency dealing with the threat of RVF outbreaks entering Europe due to climate change — this project developed Phase I/II clinical trial protocols and identified correlates of protection to speed up regulatory approval.
The project leverages 35M EUR from Horizon Europe and 15M EUR from CEPI, creating a total pool of 50M EUR.
Based on available project data, the hRVFV-4s manufacturing process was successfully transferred to Batavia Biosciences and engineering run material was produced and released.
The project is specifically identifying potential pathways to licensure through either pivotal clinical trials or pre-clinical routes to facilitate regulatory approval.
The overall project period runs from 2022-08-01 to 2026-07-31, with individual awards typically lasting 36 months.
The project is conducting Phase I/II clinical testing in endemic regions and using passive antibody studies to determine the minimal protective titre required.
The project is coordinated by CEPI (a non-profit research entity) with a lean structure of 1 official partner in Norway, but it operates as an umbrella for multiple sub-applicants. It integrates high-level academic research from the University of California, Davis, and industrial manufacturing capabilities through partners like Batavia Biosciences and IDT Biologika, ensuring a bridge between lab discovery and GMP production.
Contact the CEPI secretariat regarding the CfP3ii funding follow-ups.
Contact us to explore licensing opportunities for the hRVFV-4s manufacturing process.
