Clinical Trial: Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2b Randomized, Single-Blinded Study to Evaluate the Safety and Immunogenicity of 80 µg Recombinant Plague Vaccine (rF1V) With and Without Adjuvant at Two Vacc
Brief Summary: Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).
Detailed Summary: The objectives of this trial are: to compare the safety of rF1V vaccine administered in two different schedules through 28 days after each vaccination and cumulatively to Day 210; to compare the immunogenicity of rF1V vaccine administered in two different schedules through 28 days after Vaccination 3; to compare the safety and immunogenicity of rF1V vaccine administered by two different schedules through 12 months after Vaccination 3; and to assess the contribution of the adjuvant to the immunogenicity of the rF1V antigen.
Sponsor: DynPort Vaccine Company LLC, A CSC Company
Current Primary Outcome: To measure frequency and severity of local and systemic adverse events (AEs) through 28 days after each vaccination and cumulatively through Day 210. [ Time Frame: Day 210 for Cohorts 1 through 4 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess the frequency and severity of local and systemic AEs of rF1V vaccine with and without adjuvant administered at 2 dosing schedules. [ Time Frame: Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4. ]
- To measure the proportion of volunteers in each cohort demonstrating seroconversion to vaccine antigens and the magnitude of the immune response. [ Time Frame: Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4. ]
Original Secondary Outcome: Same as current
Information By: DynPort Vaccine Company LLC, A CSC Company
Dates:
Date Received: May 7, 2010
Date Started: July 2010
Date Completion:
Last Updated: August 14, 2013
Last Verified: August 2013