Sample size and study endpoints
SAEs
SECONDARY, ADVERSE REACTION, INJECTION SITE REACTION
The sample size of 48 participants was determined by what is reasonable for a Phase 1 trial and allows only preliminary safety and immunogenicity information relevant to the progression to larger trials. Based on previous clinical experience with the non-thermostable presentation of ID93 + GLA-SE, we estimated that a sample size of 24 participants per group would allow the detection of an increase in systemic adverse reaction frequency of >32.5% in the thermostable presentation group compared to the non-thermostable presentation group at 80% power with a one-sided confidence interval of 95%, and detection of a decrease in serum antibody response rate of >10% in the thermostable presentation group compared to the non-thermostable presentation group at 90% power with a one-sided confidence interval of 95%. This study was inclusive of all healthy adults who met the inclusion/exclusion criteria, regardless of sex. Sex was determined based on self-reporting. No sex- or gender-based analyses were performed as the study was not designed with sufficient power to adequately address this aspect. The primary endpoints included (1) the number of participants experiencing solicited local injection site reactions within 7 days following each study injection, (2) the number of participants experiencing solicited systemic reactions within 7 days following each study injection, (3) the number of participants spontaneously reporting AEs from Study Day 0 through Study Day 84, and (4) number of SAEs considered related to any of the study injections reported at any point during the study period. The secondary endpoints included (1) proportion of participants with at least a 4-fold increase in IgG antibody responses to ID93 on Study Days 14, 56, 70, 84, and 224 relative to baseline (Study Day 0) as assayed by ELISA; (2) mean fold-change from baseline in IgG antibody responses to ID93 on Study Days 14, 56, 70, 84, and 224 relative to baseline (Study Day 0) as assayed by ELISA; (3) the number of IFN-γ and IL-10 cytokine-secreting cells in PBMC samples in response to ID93 at Study Days 14, 56, 70, 84, and 224 relative to baseline (Study Day 0) as assayed by ELISpot; and (4) the percentage of CD4