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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.