Milestones en route to an onchocerciasis vaccine
The way forward for vaccine development
TOVA Initiative has set its goal to take at least one vaccine candidate to Phase I trials by 2020. To do this the following tasks have been identified:
- Mathematical modelling of vaccine efficacy design of control programmes, and cost-effectiveness.
- Systems analysis to identify specific molecular interactions between parasite and host to idenify immne correlates of protection and assist formulation of the vaccine for maximum efficacy, and avoid adverse reactions.
- Efficacy trials using the O ochengi cattle model under conditions of natural exposure.
- Process development for human recombinant vaccine production or synthetic vaccines, including formulation, assay development, quality control and stability.
- Technology transfer for cGMP manufacturing of vaccines.
- GLP toxicology testing of vaccines.
- Regulatory filing.
- Phase I, first-in-human safety trials in developed and in endemic countries.
- Assessment of immune responses of children up to 9 years age who are exposed to O volvulus infections in preparation for phase II trials