Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vacci… (NCT01122784) | Clinical Trial Compass
CompletedPhase 2
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
United States402 participantsStarted 2010-07
Plain-language summary
Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The volunteer has signed the ICF and the HIPAA authorization and has successfully completed (at least 90% correct) the Test of Understanding.
✓. The volunteer is a male or female 18 to 55 years of age (inclusive) at the time of the screening visit.
✓. The volunteer is in good health as determined by the screening physician based upon medical history and physical examination, including vital signs within acceptable ranges.
✓. The volunteer has acceptable ranges for the laboratory parameters.
✓. The volunteer has no clinically significant abnormalities on ECG.
✓. The volunteer agrees not to donate blood, plasma or blood components for therapeutic or research purposes, except to meet requirements of this study, at any time during the course of the study.
✓. The volunteer is willing to have his or her blood samples stored for future plague research studies.
✓. The volunteer is willing to comply with the requirements of the protocol through the end of the study.
Exclusion criteria
✕. History of plague exposure or disease or previous vaccination with any plague vaccine.
✕. History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin).
✕. History of anaphylaxis or other serious adverse reactions to vaccines or aluminum.
What they're measuring
1
To measure frequency and severity of local and systemic adverse events (AEs) through 28 days after each vaccination and cumulatively through Day 210.
Timeframe: Day 210 for Cohorts 1 through 4
Trial details
NCT IDNCT01122784
SponsorDynPort Vaccine Company LLC, A GDIT Company
✕. Active tuberculosis or other systemic infectious process by review of systems and PE.
✕. History of chronic illness requiring continuous or frequent medical intervention or acute/chronic untreated conditions, multiple sclerosis, immunodeficiency, autoimmune or immunosuppressive disease or use of immunosuppressive medications.
✕. Diabetes mellitus of any type requiring treatment with insulin or oral hypoglycemic drugs.
✕. History of chronic, severe or recurrent joint pain (four or more clinically significant occurrences per year requiring treatment for remission) or arthritis of any etiology other than osteoarthritis.
✕. Previous diagnosis of any serious psychiatric disorder.