Plague VaccinePhase 2NCT01122784
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
A Phase 2 study testing rF1V vaccine (with Adjuvant) and rF1V vaccine (without Adjuvant) in people with Plague Vaccine, run by DynPort Vaccine Company LLC, A GDIT Company at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Plague Vaccine
- What is being tested?
- rF1V vaccine (with Adjuvant) and rF1V vaccine (without Adjuvant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2010to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Center for Pharmceutical Research
Kansas City, Missouri, 64114
New Orleans Center for Clinical Research
Knoxville, Tennessee, 70119
Johnson County Clinical Trials
Lenexa, Kansas, 66219
Central Kentucky Research Associates
Lexington, Kentucky, 40509
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Wake Research Associates
Raleigh, North Carolina, 27612
Rochester Clinical Research
Rochester, New York, 14609
Benchmark Research
San Francisco, California, 94102
Apex Research Institute
Santa Ana, California, 92705
WRAIR Clinical Trials Center
Silver Spring, Maryland, 20910
Heartland Reseach Assoicates, LLC
Wichita, Kansas, 67207
About this study
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
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).
Read the 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.
- Conditions
- Plague Vaccine
- Being tested
- rF1V vaccine (with Adjuvant), rF1V vaccine (without Adjuvant)
- Keywords
- Plague, Vaccine
- Medical subject headings
- Plague
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rF1V vaccine (with Adjuvant)Biological
Also called Recombinant Plague Vaccine rF1V
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
rF1V vaccine (without Adjuvant)Biological
Also called Recombinant Plague Vaccine rF1V without Adjuvant
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
rF1V vaccine (with Adjuvant)Biological
Also called Recombinant Plague Vaccine rF1V
80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
rF1V vaccine (without Adjuvant)Biological
Also called Recombinant Plague Vaccine rF1V without Adjuvant
80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182 Receives: Biological: rF1V vaccine (with Adjuvant) |
| Group 2 | Active comparator | 40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182 Receives: Biological: rF1V vaccine (without Adjuvant) |
| Group 3 | Active comparator | 160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121 Receives: Biological: rF1V vaccine (with Adjuvant) |
| Group 4 | Active comparator | 40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121 Receives: Biological: rF1V vaccine (without Adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure frequency and severity of local and systemic adverse events (AEs) through 28 days after each vaccination and cumulatively through Day 210.
Measured: Day 210 for Cohorts 1 through 4
Secondary outcomes (2)
To assess the frequency and severity of local and systemic AEs of rF1V vaccine with and without adjuvant administered at 2 dosing schedules.
Measured: 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.
Measured: Through Day 540 for Cohort 1 and 2 and Day 485 for Cohorts 3 and 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plague VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Saviolakis, MD, Study director, DynPort Vaccine Company, a CSC Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122784
- Sponsor's protocol ID
- rF1V-02b
- Status last verified
- Jul 2020
- First submitted
- 7 May 2010
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01122784
- Acronym / sponsor ID
- rF1V-02b
- Conditions
- Plague Vaccine
- Keywords
- Plague, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: rF1V vaccine (with Adjuvant)160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 182 |
| Group 2 | Active comparator | Biological: rF1V vaccine (without Adjuvant)40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 182 |
| Group 3 | Active comparator | Biological: rF1V vaccine (with Adjuvant)160 Volunteers will be vaccinated with 80 mcg rF1V vaccine with adjuvant at Study Days 0, 56 and 121 |
| Group 4 | Active comparator | Biological: rF1V vaccine (without Adjuvant)40 Volunteers will be vaccinated with 80 mcg rF1V vaccine without adjuvant at Study Days 0, 56 and 121 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rF1V vaccine (with Adjuvant)Also: Recombinant Plague Vaccine rF1V80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182 | Biological | Group 1 |
| rF1V vaccine (without Adjuvant)Also: Recombinant Plague Vaccine rF1V without Adjuvant80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182 | Biological | Group 2 |
| rF1V vaccine (with Adjuvant)Also: Recombinant Plague Vaccine rF1V80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121 | Biological | Group 3 |
| rF1V vaccine (without Adjuvant)Also: Recombinant Plague Vaccine rF1V without Adjuvant80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121 | Biological | Group 4 |
Primary outcome
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
Related trials for Plague Vaccine
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Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Saviolakis, MD study director
DynPort Vaccine Company, a CSC Company
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rF1V vaccine (with Adjuvant) and rF1V vaccine (without Adjuvant) in people with Plague Vaccine, run by DynPort Vaccine Company LLC, A GDIT Company at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.