Awarded Amount$4,422,091DiseaseNTD (Dengue)InterventionVaccineDevelopment StagePreclinical DevelopmentCollaboration PartnersInstitute of Tropical Medicine (NEKKEN) Nagasaki University , National Institute of Infectious Diseases , Johns Hopkins University , Latham BioPharm Group , VLP TherapeuticsPast Project
Introduction and Background of the Project
Dengue is one of the most serious public health problems worldwide. 50% of the world’s population are at risk of dengue. Despite decades of effort, there is no effective treatment and the currently one licensed vaccine is recommended for use only in those ≥ 9 years of age. The current vaccine has been associated with a safety risk in those who were seronegative to dengue at the time of vaccination. Therefore, there is an urgent need for next-generation vaccines.
Virus-like particle (VLP)-based vaccines are an attractive approach. VLP vaccines have shown to be safe and highly immunogenic because they mimic the conformation of the authentic virus but lack the viral genome. Notably, VLP vaccines can be administered to all populations including the most vulnerable population of infants and children.
In collaboration with Nagasaki University and National Institute of Infectious diseases, Japan (NIID), VLP Therapeutics has developed a novel dengue VLP vaccine using our unique technology. In an ongoing project, we have demonstrated the efficacy of our dengue VLP vaccine in preclinical studies including non-human primates. Here we will produce this VLP vaccine to conduct and lay the groundwork for clinical trials. The long-term goal of this project is to commercialize the first flavivirus VLP vaccine.
This project involves constructing VLP dengue vaccines across all four Dengue serotypes; establishing master cell banks and manufacturing vaccines, prepare an IND package and a clinical development plan.
How can your partnership (project) address global health challenges?
Dengue is one of the most serious public health problems worldwide, with 50% of the world’s population at risk of dengue. Currently there is no effective vaccine to protect against dengue infection. VLP vaccine can be a highly effective novel vaccine and be administered to all populations.
What sort of innovation are you bringing in your project?
VLP vaccines represent a new approach to dengue vaccines since all other vaccines in development are live attenuated vaccines. Administration of live attenuated vaccines to infants is considered to be risky, and these populations are very vulnerable to dengue infection.
Role and Responsibility of Each Partner
VLP Therapeutics: As the primary contractor on this project, VLP Therapeutics is responsible for overall project coordination and oversight as well as Dengue VLP construction.
National Institute of Infectious Disease (NIID): NIID will set up and perform animal experiments to confirm vaccine production for clinical trials.
Nagasaki University: Nagasaki University will perform analyses of all studies from the animal studies performed at NIID.
Latham Biopharm Group: Latham will provide program management services which includes overseeing the timelines and coordination across all project participants.
ohns Hopkins University (JHU): With the assistance of Professor Anna Durbin, JHU will help prepare the pre-IND and IND packages and a clinical development plan.
The development and production of cGMP lots of a novel tetravalent dengue virus-like particle (VLP) vaccine