PlaguePhase 1NCT00246467
One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
A Phase 1 study testing Alhydrogel and rF1 and rV protein antigens in people with Plague, run by PharmAthene UK Limited at 10 sites in 2 countries.
Trial summary
One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Plague
- What is being tested?
- Alhydrogel and rF1 and rV protein antigens
- How many people
- 123 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2005to Apr 2007
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females.
- Aged between 18-55 years (inclusive) on Day 0 of the Study.
- Of a body mass index (BMI) of 18-35 inclusive.
- Able to understand the informed consent form and other documents required to be read by the subject.
- Willing to give signed informed consent
- Able to give a medical history without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases - (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted).
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- In the case of female subjects, they may be enrolled if one of the following criteria applies:
- Either Is not pregnant or breast feeding AND is routinely using adequate injectable or transdermal (administered at the recommended frequency) or oral contraception (at a stable dose for at least three months prior to the first dose of vaccine) and will continue to do so during the study, augmenting this contraceptive measure with a barrier method OR is sexually abstinent OR is monogamous and has a partner who has had a vasectomy (>1 month previously) OR is using a commonly recognised copper and hormone implanted intrauterine device (IUD) such as TCu-380A, TCu-220C, MLCu-375, Nova-T or LNG-20. In addition, the subject must have a negative blood pregnancy test prior to enrolment into the study (see also Criterion 9 below).
- Or Is post menopausal (defined as a female with no menstrual cycle for at least the previous 24 months AND is of menopausal age (>45 years) Or Has not had a menstrual cycle for between 12 and 24 months AND is of menopausal age (>45 years) AND has had a negative blood pregnancy test prior to enrolment into the study and a negative urine pregnancy test pre-dose.
- Or Has been surgically sterilised (confirmed by review of medical record). Or Has had a total hysterectomy at least 3 months prior to the start of the study (confirmed by review of medical record).
- A male may be enrolled if willing to use barrier methods of contraception and whose partner is using an acceptable form of contraception for 3 months after each dose.
- A female subject must have a negative urine pregnancy test prior to each dosing (unless post-menopausal, surgically sterilised, or has had a total hysterectomy, as defined in Criterion 7 above).
- 12-lead electrocardiogram (ECG) recording without signs of pathology and conduction disturbances and with a QTc interval of < 450 msec for males and < 470 msec for females. ECGs will be analysed automatically for study entry purposes and will also be analysed by a cardiologist within 24 hours. QT intervals will be recorded automatically by the ECG machines used.
Who cannot join
- Presence of any clinically significant medical condition as determined by the Investigator.
- History of clinically significant hypersensitivity or idiosyncratic reaction related to any medical product, including vaccines and aminoglycoside antibiotics (such as kanamycin).
- History or evidence of drug misuse.
- Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study (Day 0) or an investigational drug product within 30 days prior to the start of the study.
- Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamines, non-steroidal anti-inflammatory drugs (NSAID) including aspirin, acetaminophen, OTC decongestants, herbal medicines (except St. John's Wort), oral/injectable/transdermal contraceptives, OTC multi-vitamin preparations (not high-dose preparations) or oral iron supplements. Any medication taken within 7 days of the first dosing will be documented.
- History or suspicion of inability to co-operate adequately.
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- Donation of blood or blood products during the 4 weeks prior to participation in the study (Day 0).
- Immunodeficiency or clinically active autoimmune disease.
- Positive urine alcohol and/or drug screen for drugs of misuse (opiates, methadone, cocaine, amphetamines, cannabinoids, and barbiturates).
- Positive serological test for human immunodeficiency virus (HIV), and/or hepatitis B virus and/or hepatitis C virus.
- Vaccination(s) with a live vaccine in the 4 weeks prior to participation in the study, (or 'flu vaccine in the 2 weeks prior to participation), or killed / inactivated / sub-unit vaccines in the previous 3 weeks.
- Receipt of blood or plasma transfusions, or pooled gamma globulin, in the 3 months prior to participation in the study (Day 0) and/or a need for future blood or plasma transfusions during this study.
- Prior receipt of any plague vaccine.
- Prior history of plague infection (confirmed or suspected) or significant exposure to Y. pestis (e.g. a laboratory worker who regularly handles Y. pestis) as judged by the investigator.
- Clinically relevant abnormal findings on routine physical examination.
- Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatinine, serum electrolytes (sodium, potassium, chloride and bicarbonate), liver function tests (ALT, AST and GGT), lactate dehydrogenase (LDH), white blood cell count, absolute neutrophil count, platelet count, clotting and blood haemoglobin. Minor, out-of-range laboratory test results for the above tests may be allowable, at the discretion of the Investigator, if such results are within 10% of the normal ranges and considered to be not clinically significant.
- Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator.
- Presence of tattoos that cover or partially cover the upper arm, and which would limit adequate assessment of the injection site.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Accelovance
Amarillo, Texas, 79106
Florida Medical Research Institute
Gainesville, Florida, 32607
Accelovance
Huntsville, Alabama, 35802
Accelovance
Melbourne, Florida, 32935
Miami Research Associates
Miami, Florida, 33143
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Radiant Research
Pinellas Park, Florida, 33781
Accelovance
South Bend, Indiana, 46601
Accelovance
Washington D.C., District of Columbia, 20006
About this study
Official title: A Phase 1b, Multi-Centre, Parallel Group, Single Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Plague Vaccine (rF1 and rV Antigens) in Healthy Subjects
One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins).
Read the detailed description
Plague is an infection occurring in small rodents and mammals caused by the gram-negative bacterium Yersinia pestis (Y. pestis). Transmission from rodent to man is usually by a flea vector leading to the characteristic swelling of the lymph nodes draining the region of the bite, followed by a septicaemic illness (classic bubonic plague). Human-to-human transmission can occur via droplet nuclei spread by coughing of patients with bubonic or septicaemic plague who have developed pulmonary lesions (pneumonic plague). However, cases of pulmonary transmission have also been described from household pets. In pneumonic plague symptoms of a respiratory infection develop first followed by an acute onset septicaemic illness. In the military context, the likely exposure is via the inhalation route, as a Biological Warfare Agent (BWA), and therefore protection against pneumonic plague is the paramount requirement. This is a phase 1, parallel group, single-blind study of 105 healthy adult aged 18-55, randomly assigned to one of the three cohorts and will receive the same dose of vaccines (2x) and then re-randomized at 6 months to receive either a third dose or placebo, in order to determine the safety and tolerability associated with different primary immunization doses of recombinant IM plague vaccine (rF1 and rV) antigen proteins for optimum safe dose, assess responses (both antibody and cell-mediated) following immunization, investigate the correlation between cell-mediated and antibody titers and to assess the duration of the immune responses to antigens following a third dose.
- Conditions
- Plague
- Being tested
- Alhydrogel, rF1 and rV protein antigens
- Keywords
- plague
- Medical subject headings
- Plague
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlhydrogelBiological
rF1 and rV protein antigensBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of recombinant plague vaccine
Secondary outcomes (1)
Immunogenicity of recombinant plague vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmAthene UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Sheldon, MD, Principal investigator, Miami Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246467
- Sponsor's protocol ID
- 05-0005
- Other IDs
- AVEC/rYP/03
- Status last verified
- Sep 2008
- First submitted
- 27 Oct 2005
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multi-Centre, Parallel Group, Single Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant Plague Vaccine (rF1 and rV Antigens) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00246467
- Acronym / sponsor ID
- 05-0005
- Conditions
- Plague
- Keywords
- plague
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- PharmAthene UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 31 Oct 2005 (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.
One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins).
Detailed description
Plague is an infection occurring in small rodents and mammals caused by the gram-negative bacterium Yersinia pestis (Y. pestis). Transmission from rodent to man is usually by a flea vector leading to the characteristic swelling of the lymph nodes draining the region of the bite, followed by a septicaemic illness (classic bubonic plague). Human-to-human transmission can occur via droplet nuclei spread by coughing of patients with bubonic or septicaemic plague who have developed pulmonary lesions (pneumonic plague). However, cases of pulmonary transmission have also been described from household pets. In pneumonic plague symptoms of a respiratory infection develop first followed by an acute onset septicaemic illness. In the military context, the likely exposure is via the inhalation route, as a Biological Warfare Agent (BWA), and therefore protection against pneumonic plague is the paramount requirement. This is a phase 1, parallel group, single-blind study of 105 healthy adult aged 18-55, randomly assigned to one of the three cohorts and will receive the same dose of vaccines (2x) and then re-randomized at 6 months to receive either a third dose or placebo, in order to determine the safety and tolerability associated with different primary immunization doses of recombinant IM plague vaccine (rF1 and rV) antigen proteins for optimum safe dose, assess responses (both antibody and cell-mediated) following immunization, investigate the correlation between cell-mediated and antibody titers and to assess the duration of the immune responses to antigens following a third dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy males or females.
- Aged between 18-55 years (inclusive) on Day 0 of the Study.
- Of a body mass index (BMI) of 18-35 inclusive.
- Able to understand the informed consent form and other documents required to be read by the subject.
- Willing to give signed informed consent
Key exclusion criteria (18 listed)
- Presence of any clinically significant medical condition as determined by the Investigator.
- History of clinically significant hypersensitivity or idiosyncratic reaction related to any medical product, including vaccines and aminoglycoside antibiotics (such as kanamycin).
- History or evidence of drug misuse.
- Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study (Day 0) or an investigational drug product within 30 days prior to the start of the study.
- Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamines, non-steroidal anti-inflammatory drugs (NSAID) including aspirin, acetaminophen, OTC decongestants, herbal medicines (except St. John's Wort), oral/injectable/transdermal contraceptives, OTC multi-vitamin preparations (not high-dose preparations) or oral iron supplements. Any medication taken within 7 days of the first dosing will be documented.
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 |
|---|---|---|
| Alhydrogel | Biological | – |
| rF1 and rV protein antigens | Biological | – |
Primary outcome
Safety of recombinant plague vaccine
1 secondary outcome
Immunogenicity of recombinant plague vaccine
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 15 Sep 2008.
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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.
Eric Sheldon, MD principal investigator
Miami Clinical Research
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alhydrogel and rF1 and rV protein antigens in people with Plague, run by PharmAthene UK Limited at 10 sites in 2 countries.
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 13 inclusion and 18 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 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. 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?
Safety of recombinant plague vaccine. 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 15 Sep 2008.