Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
NCT ID: NCT00332956
Last Updated: 2011-12-02
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
400 participants
INTERVENTIONAL
2006-05-31
2008-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Group 1
Volunteers will be vaccinated with 80 mcg rF1V vaccine on Study Days 0 , 28, 182
rFIV vaccine
rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
Group 2
Volunteers will be vaccinated with 80 mcg of rF1V vaccine at Study Days 0, 56, 182
rF1V vaccine
rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
Group 3
Volunteers will be vaccinated with 160 mcg rF1V vaccine given on Study Days 0, 28, 182
rF1V vaccine
rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
Group 4
Volunteers will be vaccinated with 160 mcg rf1V vaccine on Study Days 0, 56, 182
rF1V vaccine 160 mcg given on Study Days 0, 56, 182
rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182
Interventions
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rFIV vaccine
rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
rF1V vaccine
rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
rF1V vaccine
rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
rF1V vaccine 160 mcg given on Study Days 0, 56, 182
rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. In good health
3. Acceptable ranges for the laboratory parameters
4. Normal ECG. If a volunteer is reported to have a benign ECG abnormality(e.g., sinus bradycardia) the results may be discussed with the medical monitors for the study.
5. Willing to have his/her blood samples stored for future plague research studies.
6. Signed the ICF and HIPPA and successfully completed the Test of Understanding (90% correct).
7. Agrees not to donate blood until at least 90 days following the last vaccination.
8. Volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 540 visit.
9. Female volunteers must be of non-childbearing potential or must not be pregnant. Must use 2 types of acceptable for of FDA approved contraception or abstinent.
Exclusion Criteria
2. Active tuberculosis or other systemic infectious process.
3. History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin)
4. Positive prescreening for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg).
5. A history of immunodeficiency or chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune disease or use of immunosuppressive medications.
6. Chronic, severe or recurrent joint pain (4 or more occurrences per year) or arthritis of any type.
7. A positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids.
8. A previous diagnosis of any serious psychiatric disorder. For this purpose, serious psychiatric disorder is defined as illness requiring hospitalization within the previous 12 months; routine administration of more than one medication to control anxiety, mood or sleep disorder; or history of suicide attempt.
9. Receipt of any blood product or immune globulin in the previous 6 months.
10. Receipt of any investigational vaccine in the previous 6 months
11. Donation of blood within 56 days prior to first vaccination or at any time prior to Day 210 visit.
12. Receipt of any investigational drug therapy within 30 days before the first dose of rF1V or intent to receive any other investigational drug therapy before the post-vaccination Day 540 visit.
13. A clinically significant abnormality on the ECG.
14. A body mass index \> or equal to 35 kg/m2
15. Acute illness, evidence of significant active infection or systemic disease at time of enrollment that in the opinion of the Investigator would place the volunteer at an unacceptable risk for injury.
16. Personal history of multiple sclerosis, since immune system stimulation may exacerbate this disorder.
17. Occupational or other responsibilities that would prevent completion of participation in the study.
18. Licensed vaccines are not exclusionary but should be given at least 2 weeks before or after immunization (if live vaccine, 60 days before or after immunization) to avoid potential confusion of adverse reactions.
19. Screening laboratory values not within acceptable ranges.
20. A history of anaphylaxis or other serious adverse reactions to vaccines.
21. The female volunteer is pregnant
22. Receipt of therapy with immunosuppressive agents, including high-dose systemic corticosteroids (i.e., prednisone-equivalent dose of \> or equal to 20 mg/day), within 3 months prior to or during the study.
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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Ivor Emmanual, MD
Role: PRINCIPAL_INVESTIGATOR
Benchmark Research
Steven Folkerth, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center of Neveda
Richard Greenberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky - Department of Infectious Disease
Vicki Grieff, MD
Role: PRINCIPAL_INVESTIGATOR
Alta Clinical Research, LLC
John Jacobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Meridian Clinical Research, LLC
Keith Reisinger, MD
Role: PRINCIPAL_INVESTIGATOR
Primary Physicians Research, Inc.
George Risi, MD
Role: PRINCIPAL_INVESTIGATOR
Infectious Disease Specialists, PC
L. Tyler Wadsworth, MD
Role: PRINCIPAL_INVESTIGATOR
Sundance Clinical Research
Iaasc Marcadis, MD
Role: PRINCIPAL_INVESTIGATOR
Palm Beach Research
Locations
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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
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
Countries
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Other Identifiers
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rF1V-02(a)
Identifier Type: -
Identifier Source: org_study_id