CEPI expands partnership with Wageningen Bioveterinary Research to advance clinical trials of Rift Valley fever vaccine in affected countries

• 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

• 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

• 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 ‘spillover' 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 Lemaître, 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 ‘One 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 Niño 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.

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Note to Editors

WBVR-led consortium partners

Wageningen Bioveterinary Research is leading a consortium comprising Batavia Biosciences BV, Bunyavax BV, CR2O BV, University of Veterinary Medicine Hannover, and Integrum Scientific, LLC.



About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched in 2017, to develop vaccines against future epidemics. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.

Prior to COVID-19, CEPI's work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus — it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

CEPI has played a central role in the global response to COVID-19, supporting the development of the world's largest portfolio of vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access, as well as co-leading COVAX, the global initiative to deliver fair and equitable access to COVID-19 vaccines. CEPI is also the world's leading funder of R&D for broadly protective coronavirus vaccines which could protect against future variants of COVID-19 as well as other coronaviruses with epidemic and pandemic potential.

CEPI has embarked upon an ambitious five-year plan — called CEPI 2.0 — to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI's goal — supported by the G7 and G20 — to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this ‘100 Days Mission' would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic. Read the plan at endpandemics.cepi.net/

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About WBVR

Wageningen Bioveterinary Research (WBVR, part of Wageningen University and Research), is an internationally renowned independent knowledge institute in the veterinary and public health domain. WBVR aims to contribute towards a society where animals and humans live a healthy life by preventing the spread of animal and zoonotic diseases and promoting health. This is achieved by top level scientific research with a focus on One Health, sustainable animal husbandry, and diagnostics. WBVR contributes to these topics by collaborating with governments, private partners, NGOs and other funding agencies.

WBVR is the national reference centre for notifiable livestock diseases in the Netherlands and advices the Dutch government on all aspects of veterinary disease control policies.

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