Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DynPort Vaccine Company LLC, A CSC Company
ClinicalTrials.gov Identifier:
NCT01122784
First received: May 7, 2010
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Plague Vaccine
Biological: rF1V vaccine (with Adjuvant)
Biological: rF1V vaccine (without Adjuvant)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To measure frequency and severity of local and systemic adverse events (AEs) through 28 days after each vaccination and cumulatively through Day 210. [ Time Frame: Day 210 for Cohorts 1 through 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the frequency and severity of local and systemic AEs of rF1V vaccine with and without adjuvant administered at 2 dosing schedules. [ Time Frame: Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4. ] [ Designated as safety issue: Yes ]
  • To measure the proportion of volunteers in each cohort demonstrating seroconversion to vaccine antigens and the magnitude of the immune response. [ Time Frame: Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4. ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182
Biological: 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
Other Name: Rcombinant Plague Vaccine rF1V
Active Comparator: Group 2
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182
Biological: 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
Other Name: Recombinant Plague Vaccine rF1V without Adjuvant
Active Comparator: Group 3
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121
Biological: 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
Other Name: Recombinant Plague Vaccine rF1V
Active Comparator: Group 4
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121
Biological: 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 Name: Recombinant Plague Vaccine rF1V without Adjuvant

Detailed Description:

The objectives of this trial are: to compare the safety of rF1V vaccine administered in two different schedules through 28 days after each vaccination and cumulatively to Day 210; to compare the immunogenicity of rF1V vaccine administered in two different schedules through 28 days after Vaccination 3; to compare the safety and immunogenicity of rF1V vaccine administered by two different schedules through 12 months after Vaccination 3; and to assess the contribution of the adjuvant to the immunogenicity of the rF1V antigen.

  Eligibility

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

Inclusion Criteria:

  1. The volunteer has signed the ICF and the HIPAA authorization and has successfully completed (at least 90% correct) the Test of Understanding.
  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:

  1. History of plague exposure or disease or previous vaccination with any plague vaccine.
  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.
  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: NCT01122784

Locations
United States, California
Benchmark Research
San Francisco, California, United States, 94102
Apex Research Institute
Santa Ana, California, United States, 92705
United States, Kansas
Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
Heartland Reseach Assoicates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
United States, Maryland
WRAIR Clinical Trials Center
Silver Spring, Maryland, United States, 20910
United States, Missouri
Center for Pharmceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, South Carolina
Coastal Carolina Research Center
Mt Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 70119
Sponsors and Collaborators
DynPort Vaccine Company LLC, A CSC Company
Investigators
Study Director: George Saviolakis, MD DynPort Vaccine Company, a CSC Company
  More Information

No publications provided

Responsible Party: DynPort Vaccine Company LLC, A CSC Company
ClinicalTrials.gov Identifier: NCT01122784     History of Changes
Other Study ID Numbers: rF1V-02b
Study First Received: May 7, 2010
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by DynPort Vaccine Company LLC, A CSC Company:
Plague
Vaccine

Additional relevant MeSH terms:
Plague
Yersinia Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014