CEPI Nipah Virus Vaccine Project
Nipah virus is an emerging virus which was first recognized in Malaysia in 1997. It caused fatal encephalitis to humans with high mortality rate of around 90 % and more than a hundred infected people have died. It still has caused infection sporadically in Bangladesh and India, but no vaccine is available yet.
Coalition for Epidemic Preparedness Innovations (CEPI) is an innovative global partnership founded in 2017. It aims to accelerate the development of vaccines against emerging infectious diseases threatening human health as Nipah virus. In February 2019, CEPI announced investing 31 million dollar in developmental research of Nipah virus vaccine for the clinical use which we have previously generated. This is the first project adopted by CEPI in Japan.
In the project, we develop the vaccine for clinical use to overcome Nipah virus infection in outbreak regions and contribute to the safety of people around the world against a thread of deadly viral infection.
What is Nipah Virus?
Nipah virus is a pathogen first identified in 1998, and causes lethal encephalitis to humans. The outbreaks of Nipah virus infection have occurred sporadically in south-east Asia, and many cases of infection and death have been reported. Since Nipah virus could cause large health hazards to humans in future, it has been categorized into "Blue print list of priority diseases" by WHO since 2015.
Fruit bats of genus Pteropus have been identified as natural reservoirs of Nipah virus. The outbreak in the Malay Peninsula in 1998 occurred due to a transmission of the virus to pig farmers from pigs which contacted with secretion and excrement of bats. In the outbreaks in Bangladesh and India, the viruses are transmitted via date palm sup contaminated with secretion and excrement of bats or by direct contacts with infected bats. The virus could be also transmitted from infected humans to humans directly.
Generation and Efficacy of Recombinant Nipah Virus Vaccine
To date in 2019, no approved therapeutic or vaccine against Nipah virus is available yet. We focused on a vaccine vector of measles virus. It has been known that measles virus induces a strong immune response called life-long immunity, and we were familiar with its characteristics because we had been engaged in development of vaccines against other infectious diseases using it as a vaccine vector. We generated a recombinant measles virus vaccine against Nipah virus (Nipah virus vaccine) using a reverse genetics system and examined its efficacy in the BSL4 institute in Lyon, France.
The results indicated that the Nipah virus vaccine provided a complete protection against lethal Nipah virus challenge in hamster infection models (see right). The complete protection was also provided in monkey infection models (Yoneda M. et. al. 2013). Therefore, these results indicate that the Nipah virus vaccine is a very promising candidate for a vaccine against Nipah virus infection.
CEPI (Coalition for Epidemic Preparedness Innovations)
Recently, various emerging viruses including Nipah virus are threating human health. Development of vaccines against these viruses is important, but is economically difficult due to its unprofitability. CEPI (Coalition for Epidemic Preparedness Innovations) was founded to stimulate and accelerate the development of vaccines against emerging infectious diseases and enable access to these vaccines for people during outbreaks.
CEPI is an innovative global partnership between public, private, philanthropic, and civil society organisations which was launched at Davos 2017 by the governments of Norway and India, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the World Economic Forum. CEPI has also received with multi-year funding from Norway, Germany, Japan, Canada, Australia, the Bill & Melinda Gates Foundation, and Wellcome as well as single-year investments from the governments of Belgium and the UK.
The first call supports candidate vaccines against MERS-CoV, Nipah virus, and Lassa virus. These diseases were chosen from a priority list established by the WHO in its R&D Blueprint for Action to Prevent Epidemics.
Nipah Virus Vaccine Project
We have planned a project of research and development for clinical use of the Nipah vaccine to save people from the lethal infection in outbreak regions. This project will be performed by a large-scale international collaboration directed by the University of Tokyo. The University of Tokyo will manage the entire project and perform the pre-clinical study and development of assay systems for diagnosis. The manufacturing will be performed by Batavia Bioscience B.V. The phase I, II clinical studies will be performed by European Vaccine Initiative (EVI) which is leading European efforts to develop vaccines together with Stanford University and International Centre for Diarrhoeal Disease Research (ICDDR) in Bangladesh. We plan to finish the phase II clinical study in five years and prepare the stockpile of the Nipah vaccine to use it in regions where outbreaks of Nipah virus infection have occurred.