Clinical Trial: Phase 3, Randomized, Safety, Lot Consistency and Clinical Benefit Study of Recombinant Botulinum Vaccine A/B
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: A Phase 3, Double Blind, Placebo Controlled, Randomized, Multicenter Clinical Trial to Demonstrate the Safety, Lot Consistency and Clinical Benefit of Recombinant Botulinum Vaccine A/B (rBV A/B)
Brief Summary: This Phase 3 clinical trial is a double blind, placebo-controlled, randomized, multicenter investigation of rBV A/B in male and female healthy adults 18 to 55 years of age.
Detailed Summary: Currently, there are no licensed vaccines or pre-exposure prophylactic medical countermeasures available to provide protection against botulism. The rBV A/B is under development to provide protection of adults 18 to 55 years of age from fatal botulism caused by inhalational intoxication with botulinum neurotoxin complex (BoNT) serotype A, subtype A1 (BoNT/A1) and botulinum neurotoxin complex serotype B, subtype B1 (BoNT/B1). Volunteers will not be exposed to botulism. Protective antibody titers will be measured in serum after vaccination.
Sponsor: DynPort Vaccine Company LLC, A CSC Company
Current Primary Outcome:
- The primary safety objective is to demonstrate the safety of rBV A/B through Day 365. [ Time Frame: 1 year after first dose [Dose 1] / 6 months after the last dose [Dose 3] ]The primary safety endpoints are the incidence, severity and relationship to treatment of solicited local, systemic and neuromuscular adverse events (AEs) with onset on the day of and for 7 days after each administration of study product; treatment-emergent AEs (TEAEs) with onset within 28 days after each administration of study product; and medically-attended AEs (MAEs), neuromuscular AEs and serious AEs (SAEs) from the time of first dose (Day 0) through 6 months after the last dose (Day 365).
- The primary immunogenicity objectives are to demonstrate lot consistency for three lots of rBV A/B and to infer clinical benefit of rBV A/B. [ Time Frame: Study Day 210, approximately 28 days after the last dose [Dose 3] ]
- The criterion to demonstrate lot consistency will be based on the geometric mean ratios of neutrailzing antibodies concentrations (NAC) to vaccine antigens BoNT/A1 and BoNT/B1.
- The criterion to demonstrate clinical benefit is the proportion of volunteers with NAC values at or above the putative protective levels for anti-BoNT/A1 and anti-BoNT/B1 simultaneously.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The secondary safety objective is to demonstrate the safety of rBV A/B from Day 365 through Day 547. [ Time Frame: 1 year after last dose [Dose 3] in a subset of volunteers ]The secondary safety endpoints are the incidence, severity and relationship to treatment of MAEs, neuromuscular AEs and SAEs.
- The secondary immunogenicity endpoints is duration of protection through Day 547. [ Time Frame: Evalution through Study Days 365 and 547 (6 months and 1 year after last dose [Dose 3]) ]The criterion to demonstrate duration of protection is the proportion of volunteers with NAC values at or above the putative protective levels for anti-BoNT/A1 and anti-BoNT/B1 simultaneously.
Original Secondary Outcome: Same as current
Information By: DynPort Vaccine Company LLC, A CSC Company
Dates:
Date Received: September 6, 2013
Date Started: October 2020
Date Completion: September 2023
Last Updated: August 4, 2016
Last Verified: November 2013