Pneumonic PlaguePhase 1NCT00097396
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
A Phase 1 study testing rF1V vaccine in people with Pneumonic Plague and Preventive Therapy, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonic Plague, Preventive Therapy
- What is being tested?
- rF1V vaccine
- Type of treatment
- Vaccines
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Sep 2006
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteer is male or female and 18 to 40 years of age (inclusive) at the time of the first dose of investigational product
- Good health as determined by screening medical history and physical examination
- The volunteer has the following laboratory parameters within normal range: total WBC, Hemoglobin, platelets, LFT (AST, ALT, ALP, Bilirubin) and/or ≤ 1+ proteinuria. Other laboratory parameters must be within 10 % of the upper or lower limits of the normal range of the University of Kentucky clinical laboratory and not clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
- The volunteer has a normal electrocardiogram (ECG). However, if a potential volunteer is reported to have a benign ECG abnormality (e.g., sinus bradycardia) the results may be discussed with the Sponsor Medical Monitor and Covalent Medical Monitor. With the agreement of the Investigator, Covalent Medical Monitor and Sponsor Medical Monitor and documentation of the consultation in the volunteer's study record the Investigator may include the volunteer in the study.
- The volunteer is willing to have his or her blood samples stored for future plague research studies.
- The volunteer has signed the Informed Consent Form, successfully completed (at least 90 % correct) the Test of Understanding, and has signed the HIPAA authorization form.
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- The volunteer agrees not to donate blood for at least 30 days following vaccination.
- The volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 180 (± 7 days) visit.
- Female volunteers must be of non-childbearing potential (i.e., surgically sterilized or postmenopausal), or must not be pregnant (as indicated by a negative serum pregnancy test within 24 hours prior to rF1V administration) or nursing, and must use two types of an acceptable form of FDA-approved contraception (barrier method, Depo-Provera, Norplant, Ortho Evra (birth control patch), oral contraceptives) through 30 days after the second (final) vaccination of rF1V (i.e. Day 58). If abstinent, two forms of birth control are not required
- The volunteer must be an active participant enrolled in Phase 1 rF1V-01 protocol - Cohort 4 (160 ug) completing day 180 procedures as defined in rF1V-01 protocol
- Have good health as determined by screening medical history and physical examination
- Have a blood potassim level of no less than 3.6 mEq/mL and have no clinically significant abnormalities on other laboratory safety tests from the study Day 180 assessments
- The volunteer has signed the informed consent form for Cohort 4 Extension
- The volunteers agrees not to donate blood for at least 30 days following vaccination
- The volunteer is willing to comply with the requirements of the protocol from the day of vaccination Study Day E-0 (-1) through Study Day E-180 (+/- 14 days)final visit
- Female volunteers must be of non-childbearing potential (i.e., surgically sterilized or postmenopausal), or must not be pregnant (as indicated by a negative blood pregnancy test within one day prior to rF1V administration) or nursing, and must use two types of an acceptable form of FDA-approved contraception (barrier method, Depo-Provera, Norplant, Ortho Evra (birth control patch), oral contraceptives) through 30 days after vaccination with rF1V (i.e. Study Day E-30). If abstinent, two forms of birth control are not required
Who cannot join
- Have a history of plague disease or have received any plague vaccine.
- Have active tuberculosis or other systemic infectious process by review of systems and physical examination.
- Have a history of allergy to kanamycin or aminoglycosides.
- Positive for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg)
- Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune disease, or use of immunosuppressive medications.
- The volunteer has chronic, severe or recurrent joint pain or arthritis of any etiology.
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- The volunteer has a positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and cannabinoids. (If positive on screen, confirmatory testing shall be performed where applicable).
- The volunteer has 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.
- The volunteer has received any blood products or immune globulin in the previous six months.
- The volunteer has donated blood within the past 56 days.
- The volunteer received any investigational drug therapy within 30 days before the first dose of rF1V or intends to receive any other investigational drug therapy before the post-vaccination Day 180 (± 7 days) visit.
- The volunteer has a clinically significant abnormality on the ECG.
- The volunteer has a body mass index 40 kg/m2 or is greater than or equal to 100 lbs over the ideal body weight.
- The volunteer has an acute illness, evidence of significant active infection, or evidence of systemic disease at time of enrollment that in the opinion of the Investigator would place the volunteer at an unacceptable risk for injury.
- Have temperature greater than or equal to 100º F on the day of scheduled 1st vaccination.
- Have personal history of multiple sclerosis, since immune system stimulation may exacerbate this disorder.
- Have 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 for total WBC, Hemoglobin, platelets, LFT (AST, ALT, ALP, Bilirubin) are not within normal range and/or more than 1+ proteinuria.
- Have a history of anaphylaxis or other serious adverse reactions to vaccines.
- The female volunteer is pregnant (must have a negative serum pregnancy test within 24 hours prior to each dose of rF1V), lactating or unwilling to use two types of an acceptable form of FDA-approved contraception through 30 days after the second (final) dose of rF1V (i.e. Day 58)
- Are receiving ongoing chemotherapy with immunosuppressive agents such as systemic corticosteroids within 3 months prior to or during the study.
- A total steroid dose of 2mg/kg or 20mg/day within 3 months (ACIP recommendation) and "Burst" therapy within 2 weeks prior to vaccination is permitted. Inhaled and topical steroids are permitted.
- Veterans with prior record of receiving any plague vaccine
- Not currently enrolled in Cohort 4 of the rF1V-01 protocol
- The volunteer received any investigational drug therapy (other than that received in the rF1V-01 study) within 30 days before vaccination with rF1V or intends to receive any other investigational drug therapy before the post-vaccination Study Day E-180 (+/- 14 days) visit
- Blood potassium level is below 3.6 mEq/L on Study Day 180 safety laboratory test or other safety laboratory values from rF1V-01 Study Day 180 (+/- 7 days) or later have clinically significant abnormalities
- The female volunteer is pregnant (must have a negative blood pregnancy test within one day prior to receipt of rF1V), lactating or unwilling to use two types of an acceptable for of FDA-approved contraception through 30 days after vaccination with rF1V (i.e., Study Day E-30)
- Have received a total prednisone-equivalent corticosteroid dose of greater than or equal to 2mg/kg or 20mg/day within 3 months (ACIP recommendation) or "Burst" therapy within 2 weeks prior to vaccination. Inhaled and topical steroids are permitted
- Have previously received any plague vaccine other than two doses of rF1V (160 ug)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
Read the detailed description
The Phase 1 clinical trial is designed as an open-label, single-center, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of a two-dose regimen of rF1V in healthy volunteers at four dose-levels (20 ug, 40 ug, 80 ug and 160 ug rF1V) in four sequential cohorts. The protocol was amended 26 January 2006 to recruit volunteers from Cohort 4 to participate in an Extension. Cohort 4 Extension volunteers will receive a third vaccination at day E-0. Day E-0 (-1) should not exceed Day 240 of the Phase 1 study.
- Conditions
- Pneumonic Plague, Preventive Therapy
- Being tested
- rF1V vaccine
- Keywords
- plague, recombinant plague vaccine, vaccine, plague vaccine, Protection against pneumonic plague
- Medical subject headings
- Plague
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rF1V vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.
Secondary outcomes (2)
To evaluate immunogenicity of a two-dose schedule of rF1V vaccine when given as an IM injection at four ascending dose-levels
To collect and store serum samples for future immunogenicity assays (e.g. ELISA).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2004 (estimated)
- Study startNov 2004
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonic PlagueStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard N Greenberg, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097396
- Sponsor's protocol ID
- rF1V-01
- Status last verified
- Jun 2011
- First submitted
- 23 Nov 2004
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00097396
- Acronym / sponsor ID
- rF1V-01
- Conditions
- Pneumonic Plague, Preventive Therapy
- Keywords
- plague, recombinant plague vaccine, vaccine, plague vaccine, Protection against pneumonic plague
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Nov 2004 (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.
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
Detailed description
The Phase 1 clinical trial is designed as an open-label, single-center, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of a two-dose regimen of rF1V in healthy volunteers at four dose-levels (20 ug, 40 ug, 80 ug and 160 ug rF1V) in four sequential cohorts. The protocol was amended 26 January 2006 to recruit volunteers from Cohort 4 to participate in an Extension. Cohort 4 Extension volunteers will receive a third vaccination at day E-0. Day E-0 (-1) should not exceed Day 240 of the Phase 1 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- The volunteer is male or female and 18 to 40 years of age (inclusive) at the time of the first dose of investigational product
- Good health as determined by screening medical history and physical examination
- The volunteer has the following laboratory parameters within normal range: total WBC, Hemoglobin, platelets, LFT (AST, ALT, ALP, Bilirubin) and/or ≤ 1+ proteinuria. Other laboratory parameters must be within 10 % of the upper or lower limits of the normal range of the University of Kentucky clinical laboratory and not clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
- The volunteer has a normal electrocardiogram (ECG). However, if a potential volunteer is reported to have a benign ECG abnormality (e.g., sinus bradycardia) the results may be discussed with the Sponsor Medical Monitor and Covalent Medical Monitor. With the agreement of the Investigator, Covalent Medical Monitor and Sponsor Medical Monitor and documentation of the consultation in the volunteer's study record the Investigator may include the volunteer in the study.
- The volunteer is willing to have his or her blood samples stored for future plague research studies.
Key exclusion criteria (30 listed)
- Have a history of plague disease or have received any plague vaccine.
- Have active tuberculosis or other systemic infectious process by review of systems and physical examination.
- Have a history of allergy to kanamycin or aminoglycosides.
- Positive for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg)
- Have a history of immunodeficiency, 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 |
|---|---|---|
| rF1V vaccine | Biological | – |
Primary outcome
To evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.
2 secondary outcomes
To evaluate immunogenicity of a two-dose schedule of rF1V vaccine when given as an IM injection at four ascending dose-levels
To collect and store serum samples for future immunogenicity assays (e.g. ELISA).
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 Jun 2011.
- sponsor websiteLink provided by the sponsor.
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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.
Richard N Greenberg, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rF1V vaccine in people with Pneumonic Plague and Preventive Therapy, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site 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 16 inclusion and 30 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 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.. 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 Jun 2011.