Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
NCT ID: NCT01122784
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
402 participants
INTERVENTIONAL
2010-07-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Group 1
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182
rF1V vaccine (with Adjuvant)
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
Group 2
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182
rF1V vaccine (without Adjuvant)
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
Group 3
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121
rF1V vaccine (with Adjuvant)
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Group 4
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121
rF1V vaccine (without Adjuvant)
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Interventions
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rF1V vaccine (with Adjuvant)
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
rF1V vaccine (without Adjuvant)
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
rF1V vaccine (with Adjuvant)
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
rF1V vaccine (without Adjuvant)
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The volunteer is a male or female 18 to 55 years of age (inclusive) at the time of the screening visit.
3. 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.
4. The volunteer has acceptable ranges for the laboratory parameters.
5. The volunteer has no clinically significant abnormalities on ECG.
6. 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.
7. The volunteer is willing to have his or her blood samples stored for future plague research studies.
8. The volunteer is willing to comply with the requirements of the protocol through the end of the study.
9. Female volunteers must be of non-childbearing potential or, if of childbearing potential, must not be pregnant or lactating and must use acceptable contraception.
Exclusion Criteria
2. History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin).
3. History of anaphylaxis or other serious adverse reactions to vaccines or aluminum.
4. Active tuberculosis or other systemic infectious process by review of systems and PE.
5. 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.
6. Diabetes mellitus of any type requiring treatment with insulin or oral hypoglycemic drugs.
7. 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.
8. Previous diagnosis of any serious psychiatric disorder.
9. Acute illness, evidence of significant active infection or evidence of systemic disease at the time of enrollment.
10. Oral temperature \> 99.5°F.
11. Receipt of chemotherapeutic and immunosuppressive agents, including high-dose systemic glucocorticoids (i.e., prednisone-equivalent dose of \> 20 mg/day).
12. Receipt of blood, any blood product or immune globulin.
13. 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.
14. Receipt of any investigational vaccine.
15. Receipt or intent of any licensed nonliving vaccine.
16. Receipt of any licensed live vaccine within 60 days before Vaccination 1
17. Donation of more than 400 mL of blood 8 weeks before Vaccination 1.
18. Occupational or other responsibilities that would prevent completion of participation in the study.
19. Weight or body mass index (BMI) outside acceptable ranges.
20. Positive screening laboratory test for HIV antibody, HCV antibody or HBsAg.
21. A positive result on a urine drug screen that tests for common substances of abuse.
22. Female volunteer is pregnant or lactating.
23. The volunteer is currently on active duty in the U.S. military, or a member or relative of the clinical site study staff.
18 Years
55 Years
ALL
Yes
Sponsors
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DynPort Vaccine Company LLC, A GDIT Company
INDUSTRY
Responsible Party
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Principal Investigators
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George Saviolakis, MD
Role: STUDY_DIRECTOR
DynPort Vaccine Company, a CSC Company
Locations
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Benchmark Research
San Francisco, California, United States
Apex Research Institute
Santa Ana, California, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
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
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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rF1V-02b
Identifier Type: -
Identifier Source: org_study_id
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