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 and delivery, as well as cost-effectiveness.
- Systems analysis to identify specific molecular interactions between parasite antigens and host immune systems to assist with formulation of the vaccine for greatest efficacy and importantly, to avoid any interaction that may lead to adverse reactions, including allergic and physiological responses.
- Optimization of immunization strategies using the three filarial small animal models.
- 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