Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
A Phase 2b Randomized, Single-Blinded Study to Evaluate the Safety and Immunogenicity of 80 µg Recombinant Plague Vaccine (rF1V) With and Without Adjuvant at Two Vaccination Schedules in Healthy Adult Volunteers
1 other identifier
interventional
402
1 country
11
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 30, 2020
July 1, 2020
1.8 years
May 7, 2010
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure frequency and severity of local and systemic adverse events (AEs) through 28 days after each vaccination and cumulatively through Day 210.
Day 210 for Cohorts 1 through 4
Secondary Outcomes (2)
To assess the frequency and severity of local and systemic AEs of rF1V vaccine with and without adjuvant administered at 2 dosing schedules.
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.
Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4.
Study Arms (4)
Group 1
ACTIVE COMPARATOR160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182
Group 2
ACTIVE COMPARATOR40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182
Group 3
ACTIVE COMPARATOR160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121
Group 4
ACTIVE COMPARATOR40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121
Interventions
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
Eligibility Criteria
You may qualify if:
- The volunteer has signed the ICF and the HIPAA authorization and has successfully completed (at least 90% correct) the Test of Understanding.
- The volunteer is a male or female 18 to 55 years of age (inclusive) at the time of the screening visit.
- The volunteer is in good health as determined by the screening physician based upon medical history and physical examination, including vital signs within acceptable ranges.
- The volunteer has acceptable ranges for the laboratory parameters.
- The volunteer has no clinically significant abnormalities on ECG.
- The volunteer agrees not to donate blood, plasma or blood components for therapeutic or research purposes, except to meet requirements of this study, at any time during the course of the study.
- The volunteer is willing to have his or her blood samples stored for future plague research studies.
- The volunteer is willing to comply with the requirements of the protocol through the end of the study.
- Female volunteers must be of non-childbearing potential or, if of childbearing potential, must not be pregnant or lactating and must use acceptable contraception.
You may not qualify if:
- History of plague exposure or disease or previous vaccination with any plague vaccine.
- History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin).
- History of anaphylaxis or other serious adverse reactions to vaccines or aluminum.
- Active tuberculosis or other systemic infectious process by review of systems and PE.
- History of chronic illness requiring continuous or frequent medical intervention or acute/chronic untreated conditions, multiple sclerosis, immunodeficiency, autoimmune or immunosuppressive disease or use of immunosuppressive medications.
- Diabetes mellitus of any type requiring treatment with insulin or oral hypoglycemic drugs.
- History of chronic, severe or recurrent joint pain (four or more clinically significant occurrences per year requiring treatment for remission) or arthritis of any etiology other than osteoarthritis.
- Previous diagnosis of any serious psychiatric disorder.
- Acute illness, evidence of significant active infection or evidence of systemic disease at the time of enrollment.
- Oral temperature \> 99.5°F.
- Receipt of chemotherapeutic and immunosuppressive agents, including high-dose systemic glucocorticoids (i.e., prednisone-equivalent dose of \> 20 mg/day).
- Receipt of blood, any blood product or immune globulin.
- Receipt of any investigational drug therapy or investigational implantable device or intent to receive any other investigational drug therapy or device throughout their study participation.
- Receipt of any investigational vaccine.
- Receipt or intent of any licensed nonliving vaccine.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Benchmark Research
San Francisco, California, 94102, United States
Apex Research Institute
Santa Ana, California, 92705, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Heartland Reseach Assoicates, LLC
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
WRAIR Clinical Trials Center
Silver Spring, Maryland, 20910, United States
Center for Pharmceutical Research
Kansas City, Missouri, 64114, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 70119, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
George Saviolakis, MD
DynPort Vaccine Company, a CSC Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 13, 2010
Study Start
July 1, 2010
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
July 30, 2020
Record last verified: 2020-07