Participant flow
A total of one hundred thirty-five (135) participants were recruited across the three cohorts. All subjects in the 3 cohorts received all 3 scheduled vaccine doses except one (1) subject in the BK-SE36/CpG arm (Cohort 1) who was lost to follow-up (migrated from the study area) after Dose 2. In brief, for Cohort 1 (21-45 years-old), a total of 64 subjects were screened; 19 of whom were assessed as ineligible, while 45 subjects were randomised 2:1 into two study arms with 30 subjects in BK-SE36/CpG and 15 subjects in the control arms (Trial profile for 3 age cohorts. The number of subjects screened, excluded, randomised and included in the final analyses is shown. The age de-escalation GO/No GO criteria were based on safety data. For each participant there was a 4-month vaccination period and a one-year follow-up after the first vaccination. Study participants in each cohort were comparable at baseline with respect to demography, height, weight, vital signs, and laboratory assessment (Demographic, clinical, and immunological characteristics of enrolled subjects.SD, standard deviation; BMI, Body Mass Index.