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Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DynPort Vaccine Company LLC, A CSC Company
ClinicalTrials.gov Identifier:
NCT00332956
First received: June 1, 2006
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Biological: rFIV vaccine
Biological: rF1V vaccine
Biological: rF1V vaccine 160 mcg given on Study Days 0, 56, 182
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Phase 2 (a), Dose-Blinded, Block-Randomized, Dose and Schedule Selection Study to Evaluate the Immunogenicity and Safety of the Recombinant Plague Vaccine rF1V in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by DynPort Vaccine Company LLC, A CSC Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To access the safety of three injections of rF1V vaccine administered IM at two dosage levels. [ Time Frame: Day 210 Interim Analysis ] [ Designated as safety issue: Yes ]
  • To access the onset and duration of the humoral immune response to F1 and V antigens [ Time Frame: Final Clinical Study Reort ] [ Designated as safety issue: No ]
  • To assess the humoral immune response to rF1V antigen [ Time Frame: Final Clinical Study Report ] [ Designated as safety issue: No ]
  • To collect and store blood samples for future plague related research. [ Time Frame: Through Study Day 540 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Volunteers will be vaccinated with 80 mcg rF1V vaccine on Study Days 0 , 28, 182
Biological: rFIV vaccine
rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
Other Name: Recombinant Plague Vaccine rF1V
Active Comparator: Group 2
Volunteers will be vaccinated with 80 mcg of rF1V vaccine at Study Days 0, 56, 182
Biological: rF1V vaccine
rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
Other Name: Recombinant Plague Vaccine rF1V
Active Comparator: Group 3
Volunteers will be vaccinated with 160 mcg rF1V vaccine given on Study Days 0, 28, 182
Biological: rF1V vaccine
rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
Other Name: Recombinant Plague Vaccine rF1V
Active Comparator: Group 4
Volunteers will be vaccinated with 160 mcg rf1V vaccine on Study Days 0, 56, 182
Biological: 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 Name: Recombinant Plague Vaccine rF1V

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female age 18 to 55 years
  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:

  1. A history of plague disease or have previously received any plague vaccine.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332956

Locations
United States, Arizona
Alta Clinical Research, LLC
Tucson, Arizona, United States, 85745
United States, California
Benchmark Research
San Francisco, California, United States, 94102
United States, Florida
Palm Beach Research
West Palm Beach, Florida, United States, 33409
United States, Kentucky
University of Kentucky - Dept. of Infectious Disease
Lexington, Kentucky, United States, 40536
United States, Missouri
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
United States, Montana
Infectious Disease Specialists, PC
Missoula, Montana, United States, 59802
United States, Nebraska
Meridian clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, Pennsylvania
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States, 15241
Sponsors and Collaborators
DynPort Vaccine Company LLC, A CSC Company
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: DynPort Vaccine Company LLC, A CSC Company
ClinicalTrials.gov Identifier: NCT00332956     History of Changes
Other Study ID Numbers: rF1V-02(a)
Study First Received: June 1, 2006
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014