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

July 28, 2020 updated by: DynPort Vaccine Company LLC, A GDIT Company

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • Benchmark Research
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clinical Trials
      • Wichita, Kansas, United States, 67207
        • Heartland Reseach Assoicates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • WRAIR Clinical Trials Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center for Pharmceutical Research
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Knoxville, Tennessee, United States, 70119
        • New Orleans Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Recombinant Plague Vaccine rF1V
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 Names:
  • Recombinant 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 Names:
  • Recombinant Plague Vaccine rF1V without Adjuvant
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 Names:
  • 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 182
Other Names:
  • Recombinant Plague Vaccine rF1V
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 Names:
  • 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 182
Other Names:
  • Recombinant Plague Vaccine rF1V without Adjuvant
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 Names:
  • Recombinant Plague Vaccine rF1V without Adjuvant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Day 210 for Cohorts 1 through 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4.
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.
Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DynPort Vaccine Company LLC, A GDIT Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: George Saviolakis, MD, DynPort Vaccine Company, a CSC Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rF1V-02b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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