Wageningen Bioveterinary Research - Rift Valley fever

'Ä¢ CEPI to invest up to $25.9 million, with support from the EU, in trials in East Africa to assess a vaccine candidate against Rift Valley Fever (RVF) in people most at risk of infection 'Ä¢ Climate change is causing the potentially deadly mosquito-borne virus to expand its reach, thereby increasing the threat it poses to the lives and livelihoods of affected populations 'Ä¢ New Phase I/IIa trials for RVF vaccine candidate will help to accelerate urgent need for a protective vaccine 10 October 2023, OSLO, Norway/ WAGENINGEN, Netherlands: The Coalition for Epidemic Preparedness Innovations (CEPI) is expanding its partnership with Wageningen Bioveterinary Research (WBVR) to advance WBVR's vaccine candidate against Rift Valley fever (RVF) through a multi-site Phase I/IIa clinical trial. Subject to regulatory and ethical approvals, the anticipated trials are scheduled to begin in 2025 in Kenya and Uganda, two countries where the mosquito-borne disease poses a significant threat to the lives and livelihoods of people in rural communities. Backed with up to US$25.9 million in funding from CEPI, with support from the European Union's Horizon Europe programme, the studies will be the first to assess the safety and immunogenicity of WBVR's RVF vaccine in countries where RVF is endemic. WBVR's live-attenuated vaccine known as hRVFV-4s, and being further developed under Wageningen spin-off Bunyavax, is currently being evaluated in a Phase I clinical trial in Belgium under a previous CEPI/ EU grant. In addition to the anticipated trials in Kenya and Uganda, CEPI will fund an extension of the ongoing Phase I study to assess immunogenicity up to 24 months; manufacturing of clinical trial materials; epidemiological research to assess the burden of infection and the risk of 'Äòspillover' transmission from animals to humans in Kenya and Uganda; and regulatory engagement, including a strategy for achieving licensure of the vaccine. The work will be a combined effort of WBVR with consortium partners Batavia Biosciences BV, Bunyavax BV, CR2O BV, University of Veterinary Medicine Hannover, and Integrum Scientific, LLC. Dr Richard Hatchett, CEO of CEPI, said: "Climate change and extreme weather are expanding the range of potential Rift Valley fever outbreaks and increasing its potential to cause devastation to the lives and livelihoods of people in rural communities in Africa and beyond. We urgently need a vaccine to strengthen our defenses against this emerging disease and protect the vulnerable populations who are exposed to it. Through CEPI's expanded partnership with Wageningen Bioveterinary Research, supported by EU funding, we will generate crucial data needed to accelerate the development of this much-needed vaccine, helping to bring a protective solution closer to the growing number of people who may be affected by this potentially deadly disease." Marc Lema√Ætre, Director-General for Research and Innovation, European Commission, said: "With the memories of the recent pandemic still fresh in our minds, we know how important it is to invest in research to prevent and control the threat from infectious diseases. An effective vaccine against Rift Valley Fever would go a long way to prevent more frequent and deadly outbreaks, with all the serious public health and socioeconomic consequences that we see today. I am pleased to see that these essential research projects can now take off with the steadfast support of the European Union and Horizon Europe, through our great collaboration with CEPI. The EU and its Member States have been among the largest contributors to CEPI since its inception. From the EU Framework Programmes for Research and Innovation, we have provided more than EUR 240 million since 2017 and we are proud of the great scientific progress the strong partnership with CEPI has produced on Ebola, Chikungunya, Rift Valley Fever, and COVID-19 so far. I am confident that the projects starting today will bring us even closer to an effective vaccine against Rift Valley Fever." Dr. Paul Wichgers Schreur, researcher at WBVR, developer of the hRVFV-4s vaccine and leader of the consortium, said: "With promising results from the Phase I clinical trial in Belgium and the continuation of the collaboration with CEPI we are taking a huge step in reducing the burden of disease in Africa where the virus continues to affect both animals and humans. In addition, a RVF vaccine will contribute to preparedness for potential virus emergence in yet unaffected regions like Europe in which susceptible mosquito species are currently expanding territory." Rift Valley fever: A climate-driven disease with epidemic potential RVF is a potentially deadly virus which can spread to people either through mosquito bites or through contact with infected livestock. The disease can cause severe symptoms such as encephalitis and hemorrhaging and kills around 1 percent of all those it infects. RVF is also profoundly destructive for the livelihoods of those in rural areas where outbreaks occur and often results in large-scale losses of livestock. Because of its impact on both people and animals, RVF is a prime candidate for a 'ÄòOne Health' approach to disease control. No safe and effective human vaccines or treatments have yet been approved for use against RVF, so their development is considered a top priority by both the Africa CDC and the World Health Organization's R&D Blueprint team. RVF was first identified in Kenya's Rift Valley, but in recent decades has steadily extended its reach across much of Africa and parts of the Middle East, putting more people in more countries at risk of infection. Outbreaks of RVF have been consistently linked with intense periods of rainfall and flooding - including those caused by the El Ni√±o phenomenon which has recently returned after a seven year absence. Heavy rains provide ideal conditions for RVF-infected mosquitoes to breed and hatch. As climate change persists, expanding the range of mosquitoes and increasing the likelihood of extreme weather events such as flooding, there is a risk that RVF outbreaks will become more frequent and widespread making the development of a protective human vaccine all the more urgent. Enabling equitable access to RVF vaccines RVF primarily impacts rural and pastoral communities living in low- and middle-income countries in East Africa. CEPI and the WBVR-led consortium are committed to enabling equitable access to RVF vaccines to the populations who need them, in line with CEPI's Equitable Access Policy. This includes planning for the potential development of investigational stockpiles for use in outbreak situations, agreeing to an affordable pricing mechanism such as Cost of Goods +%, and endeavouring to manufacture the vaccine at geographically dispersed manufacturing sites close to where outbreaks may occur in order to minimise supply risks. In addition, the clinical trial and epidemiological data generated by this project will be published open access to benefit the broader public health and research communities. This project is being awarded funds under a CEPI Call for Proposals designed to support RVF vaccine candidates through clinical trials in endemic areas, which is supported by EUR35 million provided by the European Union's Horizon Europe programme. --ENDS--