This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.
Primary Objective: To select a dosage and schedule of rF1V vaccine for further study based on the immune response to F1 and V antigens up to Day 210. Secondary Objectives: 1) To assess the safety of three injections of rF1V vaccine administered IM at two dosage levels. 2\) To assess the onset and duration of the humoral immune response to F1 and V antigens. 3\) To assess the humoral immune response to rF1V antigen. 4) To collect and store blood samples for future plague related research. Exploratory Objectives: To assess additional humoral immune responses to rF1V vaccine antigens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
400
rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
Alta Clinical Research, LLC
Tucson, Arizona, United States
Benchmark Research
San Francisco, California, United States
Palm Beach Research
West Palm Beach, Florida, United States
University of Kentucky - Dept. of Infectious Disease
To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 210
Time frame: Day 210 Interim Analysis
To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.
Time frame: Day 210 Interim Analysis
To access the onset and duration of the humoral immune response to F1 and V antigens
Time frame: Final Clinical Study Reort
To assess the humoral immune response to rF1V antigen
Time frame: Final Clinical Study Report
To collect and store blood samples for future plague related research.
Time frame: Through Study Day 540
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rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182
Lexington, Kentucky, United States
Sundance Clinical Research
St Louis, Missouri, United States
Infectious Disease Specialists, PC
Missoula, Montana, United States
Meridian clinical Research, LLC
Omaha, Nebraska, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States