Thursday July 18, 2019 0 comments
FORT COLLINS -- The Coalition for Epidemic Preparedness Innovations (CEPI) and Colorado State University announced a partnering agreement to advance the development of a vaccine candidate against Rift Valley fever (RVF) virus.
With support from the European Union’s (EU’s) Horizon 2020 program, CEPI will provide up to $9.5 million for manufacturing and preclinical studies to assess a single-dose vaccine candidate (DDVax) against RVF.
First identified in 1931 during an investigation into an outbreak among sheep on a farm in the Rift Valley of Kenya, this potentially fatal virus is found across Africa and is now emerging in the Middle East.
DDVax is a second generation RVF vaccine, which was designed after researchers identified and removed the key genes of the virus that allowed it to cause disease. Removal of these genes also stops the virus from replicating in mosquitoes -- a known vector that spreads the disease in animals and in humans -- therefore blocking this potential route of transmission.
The vaccine stimulates the body’s immune system to generate neutralizing antibodies against the RVF virus. It also likely generates a significant cellular immune response that can kill infected cells.
This investment is part of CEPI’s third call for proposals, launched earlier this year with support from the EU’s Horizon 2020 research and innovation program under grant agreement No. 857934.
Since the launch of this call in January 2019, $43 million has been invested in one Chikungunya vaccine and two RVF vaccine candidates (including DDVax).
RVF is caused by a virus transmitted by mosquitoes and blood-feeding flies that usually affect animals, including cattle, goats and sheep. However, the virus also infects animals and humans through direct contact with the blood, tissues, or organs of infected animals.
RVF mainly affects people living in pastoral communities in low-income and middle-income countries.
RVF vaccines have been used successfully to protect livestock, but no vaccine has been licensed for use in humans.
RVF can cause severe symptoms and kills about one in every hundred people it infects. In people who develop the hemorrhagic form of the disease, the fatality rate is as high as 50%.
Between May and June 2018, concurrent cases of RVF were reported in farmers in South Africa and Kenya, nearly 5000 km apart. There is also an ongoing outbreak on the island of Mayotte, a French overseas territory in the Indian Ocean. As of July 5, 2019, there have been 141 human and 124 animal cases of RVF confirmed on the island.
In view of the epidemic threat posed by RVF virus, the World Health Organization has classified it as a priority pathogen in need of urgent R&D investment.
“We’re delighted to partner with Colorado State University to develop a human vaccine against Rift Valley fever virus,” said Dr. Richard Hatchett, CEPI CEO.
“This vaccine will be the 24th candidate to join CEPI’s portfolio. Rift Valley fever has substantial epidemic potential. The world needs to accelerate its efforts to develop a vaccine against this deadly virus, and that’s exactly what we aim to achieve through this collaboration.
“By supporting the development of Rift Valley fever vaccines, CEPI hopes to improve global health security and strengthen the world’s epidemic-preparedness capacity.”
“We are excited to partner with CEPI and to work towards manufacturing a Rift Valley fever vaccine for humans,” said Alan Rudolph, CSU VP for research.
“Our team and UC Davis are well-positioned to develop this much-needed medical countermeasure to reduce suffering and mortality from this disease.”
DDVax was developed more than 10 years ago by researchers at the Centers for Disease Control and Prevention's (CDC) Viral Special Pathogens Branch. Data for preclinical studies show that the vaccine is safe, fully protective, and well-suited for large-scale production. These attributes position DDVax well as a highly promising countermeasure for humans.
The CDC researchers who developed DDVax include Dr. Brian Bird, who is now a research virologist at the One Health Institute at the University of California, Davis; Cesar Albariño and Stuart Nichol of the CDC; and Dr. Thomas Ksiazek, now at the University of Texas Medical Branch.
The consortium for this project was assembled by and is lead by John H. Wyckoff III of CSU. As part of this project, UC Davis’ One Health Institute will be working with CSU to further evaluate the safety and immune-system responses induced by DDVax to provide sufficient evidence for regulatory approval to advance the vaccine into phase 1 clinical trials in areas where RVF is endemic.