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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
402
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Benchmark Research
San Francisco, California, United States
Apex Research Institute
Santa Ana, California, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
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
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.
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80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Heartland Reseach Assoicates, LLC
Wichita, Kansas, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
WRAIR Clinical Trials Center
Silver Spring, Maryland, United States
Center for Pharmceutical Research
Kansas City, Missouri, United States
Rochester Clinical Research
Rochester, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
...and 1 more locations