Development from a TB Vaccine Trial Site in Africa and Lessons from the Ebola Experience

Tuberculosis is the deadliest infection of our time, with about 1.3 million deaths in 2017. In contrast, about 11,000 people died of Ebola between 2014 and 2016. Despite this manifest difference in mortality, there is now a licensed vaccine with up to 100% efficacy against Ebola. The developments that led to the trialing and licensure of the Ebola vaccine were historic and unprecedented. The single licensed TB vaccine (BCG) has limited efficacy. There is a dire need for a new, more efficacious TB vaccine. In order to license and deploy such vaccines, trials are needed in a limited number of sites that combine high disease incidence, research infrastructure and expertise. We first chronologically describe our twelve-year experience in building a TB vaccine trial site, an arduous and incremental process in contrast to the recent Ebola outbreak, which illustrates that sites can be set up under great adversity. Due to the striking differences in the vaccine development of the two diseases, we also compare the number of respective human trials between the two diseases, using publicly available data. Relative to the Ebola pipeline, TB vaccines have fewer trials and a paucity of government and industry led trials. While acknowledging pathogens have varying levels of difficulty in the development of new vaccine candidates, there yet appears to be greater interest in funding and coordinating Ebola interventions. We are convinced that TB is a global threat that requires similar concerted effort for elimination. Funding Statement: AERAS, EDCTP and GSK funded the studies included in the manuscript. None had a role in interpreting results in the article or the decision to publish. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: The authors stated that ethics approval was obtained for all the studies included, but was not applicable to this article.