Prevention and Treatment in the Global Tuberculosis Epidemic: Approaches and Strategies in Current Clinical Trials

OBJECTIVES: In 2015, the World Health Organization published its 20-year report on the global “battle against tuberculosis (TB)” and introduced a new era with a goal to end the TB epidemic globally. The reported estimated 9.6 million new cases of TB in the prior year, and 1.5 million deaths. The End TB Strategy sought to, by 2030, reduce the number of TB deaths by 90% (from 2015) and cut new cases by 80%. The objective of this study was to perform a landscape review of ongoing TB prevention and cure strategies using current clinical trial data to gain insight into how close we are to reaching the WHO goals at the 8-year mark.

METHODS: The study used clinical trial data retrieved from www.clinicaltrials.gov. Active and completed TB clinical trial listings from 2015 to present were assessed, categorized, and summarized to identify trends in the current TB treatment and prevention landscape.

RESULTS: As of 1/15/2023 there were 565 active TB clinical trials internationally. Of these, 49.7% were completed and the remainder were recruiting or not yet enrolled. A total of 253 (46.0%) were drug studies. Of these, 21.3% were preventative and 78.6% were TB treatment trials. Among all trials, 23.3% were in the early Phase I of development, 38.7% were in Phase II, and 32.2% in Phase III or IV. Advancements of note include a live attenuated Mycobacterium vaccine (in Phase I/II), a recombinant TB vaccine (Phase III), and several new combinations targeting drug-resistant TB (Phase I-III).

CONCLUSIONS: The results epitomize the expectations for the evolving TB prevention and treatment landscape for the next 5-10 years. They suggest that coming vaccines and unique treatments to combat TB are largely in the middle phase of development. While some headway has been made toward achieving the 2015 End TB goal then, progress has been slow.