The Phase 1 clinical trial is designed as a single-center, open-label, non-randomized study to evaluate the safety, tolerability and immunogenicity of a two-dose schedule of rBV A/B in healthy volunteers at three ascending dosage levels, 5 ug, 10 ug and 20 ug serotype-specific antigen (10 ug, 20 ug and 40 ug total immunizing protein) in three dosing cohorts and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level. Approximately 44 volunteers (11 per cohort) are expected to be enrolled. Cohorts will enroll consecutively beginning with the lowest dosage level. Volunteers in each cohort will receive a two injection series at the assigned dosage level given as a 0.5 mL intramuscular (i.m.) injection on Day 0 and Day 28. Potential volunteers for study participation will undergo qualification screening for this study during the 21 days prior to the date scheduled for vaccination. After successful completion of the informed consent process and all screening assessments, volunteers will be scheduled for vaccination. Volunteers will report acute adverse events daily for 28 days after each vaccination and return to the clinic at regular intervals according to the Schedule of Study Assessments with the last scheduled follow-up 168 days (± 7 days) after the initial vaccination (Day 0).
The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.