The way forward for vaccine development
TOVA Initiative has set its goal to take at least one vaccine candidate to Phase I trials by 2022.
Prepative work has included
- 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.
The next steps (Table 2) will involve
- Vaccine manufacture in accordance with Good Manufacturing Practice and WHO and national regulatory processes.
- Toxicology testing of vaccines to comply with WHO and national regulatory processes.
- Phase Ia, first-in-human safety trials involving person who have not been exposed to onchocerciasis or related infections.
- Phase Ib, human safety trials involving persons living in onchocercais endemic regions and therfore exposed to infection.
- Imunological profiling of pre-school children to assess immune responses in those exposed to O volvulus infections and in preparation for phase II trials
- Imunological profiling of pre-school children to assess immune responses following exposure to co-infection with O volvulus and Loa loa.
- Investigation of social and cultural attitudes of vaccination and which may influence and uptake of a vaccine.
- Mathematical assessment of vaccine efficacy and economic benefit of vaccination.
Table 2, Milestones en route to an onchocerciasis vaccine