One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF… (NCT00246467) | Clinical Trial Compass
CompletedPhase 1
One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
United States123 participantsStarted 2005-10
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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).
. 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.