Plague Vaccine Clinical Trial
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 Vaccination Schedules in Healthy Adult Volunteers
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).
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. ;