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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Volunteers will be vaccinated with 80 mcg rF1V vaccine on Study Days 0 , 28, 182 |
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| Group 2 | Active Comparator | Volunteers will be vaccinated with 80 mcg of rF1V vaccine at Study Days 0, 56, 182 |
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| Group 3 | Active Comparator | Volunteers will be vaccinated with 160 mcg rF1V vaccine given on Study Days 0, 28, 182 |
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| Group 4 | Active Comparator | Volunteers will be vaccinated with 160 mcg rf1V vaccine on Study Days 0, 56, 182 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rFIV vaccine | Biological | rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182 |
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| Measure | Description | Time Frame |
|---|---|---|
| To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 210 | Day 210 Interim Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| To access the safety of three injections of rF1V vaccine administered IM at two dosage levels. | Day 210 Interim Analysis | |
| To access the onset and duration of the humoral immune response to F1 and V antigens | Final Clinical Study Reort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivor Emmanual, MD | Benchmark Research | Principal Investigator |
| Steven Folkerth, MD | Clinical Research Center of Neveda | Principal Investigator |
| Richard Greenberg, MD | University of Kentucky - Department of Infectious Disease | Principal Investigator |
| Vicki Grieff, MD | Alta Clinical Research, LLC | Principal Investigator |
| John Jacobsen, MD | Meridian Clinical Research, LLC | Principal Investigator |
| Keith Reisinger, MD | Primary Physicians Research, Inc. | Principal Investigator |
| George Risi, MD | Infectious Disease Specialists, PC | Principal Investigator |
| L. Tyler Wadsworth, MD | Sundance Clinical Research | Principal Investigator |
| Iaasc Marcadis, MD | Palm Beach Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta Clinical Research, LLC | Tucson | Arizona | 85745 | United States | ||
| Benchmark Research |
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| rF1V vaccine | Biological | rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182 |
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| rF1V vaccine | Biological | rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182 |
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| rF1V vaccine 160 mcg given on Study Days 0, 56, 182 | Biological | rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182 |
|
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| To assess the humoral immune response to rF1V antigen | Final Clinical Study Report |
| To collect and store blood samples for future plague related research. | Through Study Day 540 |
| San Francisco |
| California |
| 94102 |
| United States |
| Palm Beach Research | West Palm Beach | Florida | 33409 | United States |
| University of Kentucky - Dept. of Infectious Disease | Lexington | Kentucky | 40536 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Infectious Disease Specialists, PC | Missoula | Montana | 59802 | United States |
| Meridian clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Primary Physicians Research, Inc. | Pittsburgh | Pennsylvania | 15241 | United States |