An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

Abstract A new tuberculosis vaccine is a high priority. However, the classical development pathway is a major deterrent. Most tuberculosis cases arise within 2 years after Mycobacterium tuberculosis exposure, suggesting a 3-year trial period should be possible if sample size is large to maximize the number of early exposures. Increased sample size could be facilitated by working alongside optimized routine services for case ascertainment, with strategies for enhanced case detection and safety monitoring. Shortening enrolment could be achieved by simplifying screening criteria and procedures and strengthening site capacity. Together, these measures could enable radically shortened phase 3 tuberculosis vaccine trials. A new tuberculosis vaccine is urgent but licensure requires clinical trials that take many years. Options for an accelerated phase 3 tuberculosis vaccine prevention of disease trial through increasing trial sample size and shortening the enrolment period are discussed.