In September 2023 CEPI and the University of California, Davis (UC Davis) announced a partnership to advance human trials of a novel vaccine against the “potentially deadly” Rift Valley fever virus (RVF). CEPI is expected to provide funding of up to $28.5 million, with support from the EU’s Horizon Europe programme. This funding will support the team led by the One Health Institute at the School of Veterinary Medicine at UC Davis as they conduct Phase I and Phase II trials.
Endemic in Tanzania
The studies will take place in Tanzania, where the mosquito borne RVF presents a “significant threat” to the lives and livelihoods of people in rural communities. They will be amongst the first CEPI-funded trials to take place in an RVF endemic region. Although first identified in Kenya’s Rift Valley, the disease has “steadily extended” its reach across Africa and parts of the Middle East.
CEPI describes RVF as a “potentially deadly virus”, which is transmitted through mosquito bites or contact with infected livestock. It can cause severe symptoms, such as encephalitis, and kills around 1% of infected patients. It is also “profoundly destructive” for people whose livelihoods depend on livestock. Outbreaks are “consistently linked” with intense periods of rainfall and flooding, which provide “ideal conditions” for RVF-infected mosquitoes to breed and hatch.
As it effects 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 are approved for use, so the development of interventions is considered a top priority.
DDVax and technology transfer
The studies will assess the safety and immunogenicity of UC Davis’ live-attenuated vaccine, DDVax, in people most at risk of infection. DDVax is under evaluation in preclinical studies funded by CEPI and the EU. The Phase I trial is set to begin in 2024, subject to regulatory and ethical approvals. Alongside the trials in Tanzania, CEPI will fund technology transfer of assays and samples to laboratories in Tanzania. Further regulatory engagement will be offered to support a pathway to licensure for the vaccine.
Dr Brian Bird, Project Director at UC Davis One Health Institute, commented that a One Health approach is “essential” to control the disease.
“We are tremendously excited to work with CEPI and our partners to evaluate the safety and immunogenicity of DDVax in clinical trials in Tanzania, and to understand the underlying epidemiology of this deadly zoonotic disease.”
He hopes that the multidisciplinary team can “improve the lives of people, animals, and communities across the world”. Dr Ally Olutu, Head, Department of Interventions & Clinical Trials at Ifakara Health Institute agrees that an effeective vaccine for humans would be a “game changer for public health”.
“The Ifakara Health Institute is delighted to partner with UC Davis and CEPI to evaluate the DDVax candidate, and work to understand the dynamics of RVF transmission to inform vaccine deployment in the future.”
A promising candidate
Dr Richard Hatchett, CEPI’s CEO, commented on the need for vaccines to tackle the “devastating impact” that the disease can inflict on “vulnerable communities”.
“Climate change is making weather patterns ever more volatile, increasing the risk of more frequent and widespread outbreaks of this potentially deadly virus, and making the development of safe and effective vaccines more urgent than ever before.”
Dr Hatchett hopes to advance the “promising vaccine candidate” and generate “crucial data” in the population “most likely to benefit from its protection in the future”. Marc Lemaître is Director-General for Research and Innovation at the European Commission. He reflected on the “memories of the recent pandemic” as a driving force for investment in further research.
“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.”
He is “pleased” that the “essential research” can progress with the “steadfast support” of the EU and Horizon Europe.
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