ONE OBJECTIVE: VALIDATING OUR RIFT VALLEY FEVER VACCINE CANDIDATE
LARISSA will manufacture and validate a vaccine for the prevention of Rift Valley fever in humans. The project encompasses vaccine manufacturing, preclinical research, and a Phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose of the vaccine.
To produce this vaccine candidate, researchers at Wageningen Bioveterinary Research (WBVR) have altered the genome of the Rift Valley fever virus in a way that makes it harmless for both animals and humans. This “attenuated” virus will be used as a vaccine to generate a lasting immune response against the disease.
What's being done
The Rift Valley fever vaccine is referred to as RVFV-4s. To prepare it for use as a human vaccine, researchers from the LARISSA consortium will establish a solid GMP manufacturing process. This will take place at IDT Biologika GmbH in Germany - a company that specializes in translating vaccines from the research lab through clinical development to large-scale manufacturing, fill/finish, packaging and quality control. The resulting clinical-grade vaccine will be ready for human application.
To produce the RVFV-4s vaccine candidate, researchers at WBVR have altered the genome of the Rift Valley fever virus in a way that significantly weakens it. This “attenuated” virus will be used as a vaccine to generate a lasting immune response against the disease. Earlier, it has been determined that RVFV-4s is safe and efficacious after a single dose in various animal models. Now, the final step to bring the vaccine to the clinical phase I study is to confirm the preclinical safety and efficacy of the GMP-manufactured vaccine. This work is performed at WBVR as well.
Phase 1 trial
A phase I clinical trial with healthy volunteers will take place in Belgium at Ghent University Hospital. In this study, the safety of the vaccine candidate will be documented. CR2O BV - a full-service clinical research organisation - will coordinate the clinical trial. The CEVAC Clinical Trial Unit of Ghent University Hospital will implement and sponsor the clinical trial. The CEVAC Immunomonitoring Laboratory will handle biological material resulting from the study.
About Rift Valley fever
Rift Valley fever vaccines have already been used successfully to protect livestock, but currently none have been licensed for use in humans. While the virus mostly infects humans through contact with the blood or organs of infected animals, there is a concern that it could also be transmitted from human-to-human by the Aedes aegypti mosquito. Rift Valley fever kills about one in every hundred people infected. In people who develop the haemorrhagic form of the disease, the fatality rate is as high as 50%. There is a high unmet need to develop a safe and efficacious vaccine against the disease in humans - the final goal of the LARISSA consortium.