Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
Primary Purpose
Plague Vaccine
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rF1V vaccine (with Adjuvant)
rF1V vaccine (without Adjuvant)
rF1V vaccine (with Adjuvant)
rF1V vaccine (without Adjuvant)
Sponsored by
About this trial
This is an interventional other trial for Plague Vaccine focused on measuring Plague, Vaccine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Receipt of any licensed live vaccine within 60 days before Vaccination 1
- Donation of more than 400 mL of blood 8 weeks before Vaccination 1.
- Occupational or other responsibilities that would prevent completion of participation in the study.
- Weight or body mass index (BMI) outside acceptable ranges.
- Positive screening laboratory test for HIV antibody, HCV antibody or HBsAg.
- A positive result on a urine drug screen that tests for common substances of abuse.
- Female volunteer is pregnant or lactating.
- The volunteer is currently on active duty in the U.S. military, or a member or relative of the clinical site study staff.
Sites / Locations
- Benchmark Research
- Apex Research Institute
- Johnson County Clinical Trials
- Heartland Reseach Assoicates, LLC
- Central Kentucky Research Associates
- WRAIR Clinical Trials Center
- Center for Pharmceutical Research
- Rochester Clinical Research
- Wake Research Associates
- Coastal Carolina Research Center
- New Orleans Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121
Outcomes
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.
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.
To measure the proportion of volunteers in each cohort demonstrating seroconversion to vaccine antigens and the magnitude of the immune response.
Full Information
NCT ID
NCT01122784
First Posted
May 7, 2010
Last Updated
July 28, 2020
Sponsor
DynPort Vaccine Company LLC, A GDIT Company
1. Study Identification
Unique Protocol Identification Number
NCT01122784
Brief Title
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DynPort Vaccine Company LLC, A GDIT Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plague Vaccine
Keywords
Plague, Vaccine
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121
Intervention Type
Biological
Intervention Name(s)
rF1V vaccine (with Adjuvant)
Other Intervention Name(s)
Recombinant Plague Vaccine rF1V
Intervention Description
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
Intervention Type
Biological
Intervention Name(s)
rF1V vaccine (without Adjuvant)
Other Intervention Name(s)
Recombinant Plague Vaccine rF1V without Adjuvant
Intervention Description
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
Intervention Type
Biological
Intervention Name(s)
rF1V vaccine (with Adjuvant)
Other Intervention Name(s)
Recombinant Plague Vaccine rF1V
Intervention Description
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Intervention Type
Biological
Intervention Name(s)
rF1V vaccine (without Adjuvant)
Other Intervention Name(s)
Recombinant Plague Vaccine rF1V without Adjuvant
Intervention Description
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Receipt of any licensed live vaccine within 60 days before Vaccination 1
Donation of more than 400 mL of blood 8 weeks before Vaccination 1.
Occupational or other responsibilities that would prevent completion of participation in the study.
Weight or body mass index (BMI) outside acceptable ranges.
Positive screening laboratory test for HIV antibody, HCV antibody or HBsAg.
A positive result on a urine drug screen that tests for common substances of abuse.
Female volunteer is pregnant or lactating.
The volunteer is currently on active duty in the U.S. military, or a member or relative of the clinical site study staff.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Saviolakis, MD
Organizational Affiliation
DynPort Vaccine Company, a CSC Company
Official's Role
Study Director
Facility Information:
Facility Name
Benchmark Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Johnson County Clinical Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Heartland Reseach Assoicates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
WRAIR Clinical Trials Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Center for Pharmceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
70119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
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