Healthy VolunteersPhase 2NCT00332956

Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers

A Phase 2 study testing rFIV vaccine, rF1V vaccine and rF1V vaccine 160 mcg given on Study Days 0, 56, 182 in people with Healthy Volunteers, run by DynPort Vaccine Company LLC, A GDIT Company at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: rFIV vaccine, rF1V vaccine and rF1V vaccine 160 mcg given on Study Days 0, 56, 182
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 9 sitesUnited States
Study dates: May 2006to Oct 2008
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

Male or Female age 18 to 55 years
In good health
Acceptable ranges for the laboratory parameters
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.
Willing to have his/her blood samples stored for future plague research studies.
Signed the ICF and HIPPA and successfully completed the Test of Understanding (90% correct).

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Agrees not to donate blood until at least 90 days following the last vaccination.
Volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 540 visit.
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.

Who cannot join

A history of plague disease or have previously received any plague vaccine.
Active tuberculosis or other systemic infectious process.
History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin)
Positive prescreening for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg).
A history of immunodeficiency or chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune disease or use of immunosuppressive medications.
Chronic, severe or recurrent joint pain (4 or more occurrences per year) or arthritis of any type.

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A positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids.
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.
Receipt of any blood product or immune globulin in the previous 6 months.
Receipt of any investigational vaccine in the previous 6 months
Donation of blood within 56 days prior to first vaccination or at any time prior to Day 210 visit.
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.
A clinically significant abnormality on the ECG.
A body mass index > or equal to 35 kg/m2
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.
Personal history of multiple sclerosis, since immune system stimulation may exacerbate this disorder.
Occupational or other responsibilities that would prevent completion of participation in the study.
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.
Screening laboratory values not within acceptable ranges.
A history of anaphylaxis or other serious adverse reactions to vaccines.
The female volunteer is pregnant
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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
University of Kentucky - Dept. of Infectious Disease
Lexington, Kentucky, 40536
Infectious Disease Specialists, PC
Missoula, Montana, 59802
Meridian clinical Research, LLC
Omaha, Nebraska, 68134
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, 15241
Benchmark Research
San Francisco, California, 94102
Sundance Clinical Research
St Louis, Missouri, 63141
Alta Clinical Research, LLC
Tucson, Arizona, 85745
Palm Beach Research
West Palm Beach, Florida, 33409

Other trials in United States

About this study

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

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.

Read the 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.

To assess the onset and duration of the humoral immune response to F1 and V antigens.
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.

Conditions: Healthy Volunteers
Being tested: rFIV vaccine, rF1V vaccine, rF1V vaccine 160 mcg given on Study Days 0, 56, 182

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rFIV vaccineBiological
Also called Recombinant Plague Vaccine rF1V
rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
rF1V vaccineBiological
Also called Recombinant Plague Vaccine rF1V
rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
rF1V vaccineBiological
Also called Recombinant Plague Vaccine rF1V
rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
rF1V vaccine 160 mcg given on Study Days 0, 56, 182Biological
Also called Recombinant Plague Vaccine rF1V
rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182

Study groups in NCT00332956
Study group	Role	What they receive
Group 1	Active comparator	Volunteers will be vaccinated with 80 mcg rF1V vaccine on Study Days 0 , 28, 182 Receives: Biological: rFIV vaccine
Group 2	Active comparator	Volunteers will be vaccinated with 80 mcg of rF1V vaccine at Study Days 0, 56, 182 Receives: Biological: rF1V vaccine
Group 3	Active comparator	Volunteers will be vaccinated with 160 mcg rF1V vaccine given on Study Days 0, 28, 182 Receives: Biological: rF1V vaccine
Group 4	Active comparator	Volunteers will be vaccinated with 160 mcg rf1V vaccine on Study Days 0, 56, 182 Receives: Biological: rF1V vaccine 160 mcg given on Study Days 0, 56, 182

What is being measured

The primary outcome is the main question the study is designed to answer.

To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 210
Measured: Day 210 Interim Analysis

Secondary outcomes (4)

To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.
Measured: Day 210 Interim Analysis
To access the onset and duration of the humoral immune response to F1 and V antigens
Measured: Final Clinical Study Reort
To assess the humoral immune response to rF1V antigen
Measured: Final Clinical Study Report
To collect and store blood samples for future plague related research.
Measured: Through Study Day 540

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Oct 2008

First posted2 Jun 2006 (estimated)
Study startMay 2006
Primary completionFeb 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00332956
Sponsor's protocol ID: rF1V-02(a)
Status last verified: Nov 2011
First submitted: 1 Jun 2006
Last updated: 2 Dec 2011
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00332956
Acronym / sponsor ID: rF1V-02(a)
Conditions: Healthy Volunteers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: DynPort Vaccine Company LLC, A GDIT CompanyIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Feb 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 2 Jun 2006 (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.

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.

To assess the onset and duration of the humoral immune response to F1 and V antigens.
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.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1	Active comparator	Biological: rFIV vaccineVolunteers will be vaccinated with 80 mcg rF1V vaccine on Study Days 0 , 28, 182
Group 2	Active comparator	Biological: rF1V vaccineVolunteers will be vaccinated with 80 mcg of rF1V vaccine at Study Days 0, 56, 182
Group 3	Active comparator	Biological: rF1V vaccineVolunteers will be vaccinated with 160 mcg rF1V vaccine given on Study Days 0, 28, 182
Group 4	Active comparator	Biological: rF1V vaccine 160 mcg given on Study Days 0, 56, 182Volunteers will be vaccinated with 160 mcg rf1V vaccine on Study Days 0, 56, 182

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male or Female age 18 to 55 years
In good health
Acceptable ranges for the laboratory parameters
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.
Willing to have his/her blood samples stored for future plague research studies.

Key exclusion criteria (22 listed)

A history of plague disease or have previously received any plague vaccine.
Active tuberculosis or other systemic infectious process.
History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin)
Positive prescreening for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg).
A history of immunodeficiency or chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune 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
rFIV vaccineAlso: Recombinant Plague Vaccine rF1VrF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182	Biological	Group 1
rF1V vaccineAlso: Recombinant Plague Vaccine rF1VrF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182	Biological	Group 2
rF1V vaccineAlso: Recombinant Plague Vaccine rF1VrF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182	Biological	Group 3
rF1V vaccine 160 mcg given on Study Days 0, 56, 182Also: Recombinant Plague Vaccine rF1VrF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182	Biological	Group 4

Primary outcome

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

4 secondary outcomes

To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.
Time frame: Day 210 Interim Analysis
To access the onset and duration of the humoral immune response to F1 and V antigens
Time frame: Final Clinical Study Reort
To assess the humoral immune response to rF1V antigen
Time frame: Final Clinical Study Report
To collect and store blood samples for future plague related research.
Time frame: Through Study Day 540

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 2 Dec 2011.

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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.

Ivor Emmanual, MD principal investigator

Benchmark Research

Steven Folkerth, MD principal investigator

Clinical Research Center of Neveda

Richard Greenberg, MD principal investigator

University of Kentucky - Department of Infectious Disease

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 22 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 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00332956.

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 2 Dec 2011.