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
Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant (rF1V-1018) 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-1018 with a three-dose regimen of rF1V vaccine alone. The study will be conducted in 2 parts (Part 1 and Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
rF1V vaccine and CpG 1018® adjuvant
rF1V vaccine
Optimal Research Alabama
Huntsville, Alabama, United States
Optimal Research California
San Diego, California, United States
Optimal Research Florida
Melbourne, Florida, United States
Optimal Research Illinois
Peoria, Illinois, United States
Rates of Reactogenicity and Safety
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
Time frame: Day 1 to Week 56
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Optimal Research Maryland
Rockville, Maryland, United States
Optimal Research Texas
Austin, Texas, United States