Introduction
TB, infections
INFECTIONS, TUBERCULOSIS (TB)
Tuberculosis (TB) is a leading infectious cause of morbidity and mortality, having killed 1.5 million people and caused 10 million new infections globally in 2020. Two-thirds of new cases occur in eight countries (India, China, Indonesia, Philippines, Pakistan, Nigeria, Bangladesh, and South Africa)Efforts to develop new TB vaccines have most often relied on the rational selection of antigens made more immunogenic by the combination with vaccine adjuvantsVarious technologies can be employed to increase the thermostability of vaccinesHere, we present results from a Phase 1, randomized, double-blind clinical trial designed to evaluate the safety, tolerability, and immunogenicity of this single-vial lyophilized ID93 + GLA-SE vaccine candidate compared to the previously developed two-vial presentation in healthy adult subjects. We show the thermostable single-vial presentation of ID93 + GLA-SE elicits a similar safety profile and a comparable or improved immunogenicity profile to the non-thermostable two-vial vaccine presentation.