Study design and participants
This study was a Phase 1, randomized, double-blind clinical trial designed to evaluate the safety, tolerability, and immunogenicity of thermostable single-vial lyophilized ID93 + GLA-SE compared to the non-thermostable two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult participants. The study was performed under an investigational new drug (IND) with the US Food and Drug Administration (FDA), and the protocol, informed consent form, and other study materials were approved by the Saint Louis University Institutional Review Board. The clinical trial is registered at ClinicalTrials.gov under Identifier NCT03722472.The study was conducted at a single site (Saint Louis University Center for Vaccine Development in St. Louis, MO) and recruited participants from St. Louis, Missouri, and the surrounding area. A total of 48 male and female participants aged 18 to 55 years and in general good health were enrolled, as planned per Study Protocol (