One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
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
2 other identifiers
interventional
123
2 countries
10
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2005
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 27, 2005
CompletedFirst Posted
Study publicly available on registry
October 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedSeptember 15, 2008
September 1, 2008
1.5 years
October 27, 2005
September 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of recombinant plague vaccine
Secondary Outcomes (1)
Immunogenicity of recombinant plague vaccine
Interventions
Eligibility Criteria
You may qualify if:
- 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).
- 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).
- 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.
You may not qualify if:
- 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.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Accelovance
Huntsville, Alabama, 35802, United States
Accelovance
Washington D.C., District of Columbia, 20006, United States
Florida Medical Research Institute
Gainesville, Florida, 32607, United States
Accelovance
Melbourne, Florida, 32935, United States
Miami Research Associates
Miami, Florida, 33143, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Accelovance
South Bend, Indiana, 46601, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Accelovance
Amarillo, Texas, 79106, United States
Simbec Research Limited
Merthyr Tydfil, CF48 4DR, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Sheldon, MD
Miami Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 27, 2005
First Posted
October 31, 2005
Study Start
October 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
September 15, 2008
Record last verified: 2008-09