Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine alone in adults. Approximately two hundred healthy adults 18 to 55 years of age will be enrolled to compare a two-dose regimen of rF1V vaccine with CpG 1018® adjuvant administered on study Days 1 and 29 (and placebo at Day 183) with a three-dose regimen of rF1V vaccine alone administered on study Days 1, 29, and 183. The study will be conducted in 2 parts (Part 1 and Part 2).
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age