Abstract
Current licensure trials of new vaccines to prevent Tuberculosis (TB) disease use bacteriologically-confirmed symptomatic TB disease (sTB) as the primary endpoint. Globally, the incidence of sTB is relatively low, making licensure trials large, long and expensive. New data suggest bacteriologically-confirmed asymptomatic TB (aTB) may occur more frequently than sTB. Therefore, if vaccines have efficacy against aTB, TB vaccine licensure trials could be smaller/shorter by including aTB in the primary endpoint. We describe potential benefits and risks of including aTB in the primary endpoint of TB vaccine licensure trials. We simulate licensure trial endpoint accrual. We summarise feedback from anonymous regulators and policymakers on what they need to know about aTB to consider this proposal, and research studies to fill these evidence gaps. Research studies are needed to evaluate if bacteriologically-confirmed aTB could be included in primary endpoint of TB licensure trials. If so, it could lead to cheaper/more rapid TB vaccine development.