TOVA: next steps
The biggest challenge facing TOVA is funding for Good Manufacturing Practice to produce the vaccine and first-in-human safety trials.
TOVA: Next steps
TOVA has set its goals to take at least one vaccine candidate through Phase I trials by 2025 and Phase II trials by 2030. To achieve these goals, the following major tasks must be completed (Table 4).
1. Large scale production of the vaccines in compliance with Current Good Manufacturing Practice (cGMP) regulations. Supporting actions will include; statutory toxicity testing (this provides a stop-go point for vaccine selection); and, development of vaccine-specific immunological tests to monitor responses in vaccinated individuals.
2. First-in-human safety trials. This work will be done in two stages: (1) A phase 1a trial in non-exposed individuals, and (2) a phase 1b trials in exposed individuals. Each provides a stop-go point for vaccine selection.
3. Assessment of immune responses in primary target cohorts. Immunological profiling of pre-school children to define responses to vaccine candidates in populations living in onchocerciasis-only endemic regions of Ghana, and second, children living in onchocerciasis and loiasis co-endemic areas of Cameroon. This work will provide input to mathematical modelling of potential vaccine efficacy and design of control programmes.
4. Investigation of social and cultural attitudes towards vaccination for the purpose of assessing the feasibility and impact of control programmes using the vaccine.
5. Statistical analyses and monitoring of all research outputs and modelling of vaccine efficacy and predicted impact on disease control.