Dose Escalation Trial of a Plague Vaccine, Flagellin/F1/V, in Healthy Adult Volunteers (NCT01381744) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Trial of a Plague Vaccine, Flagellin/F1/V, in Healthy Adult Volunteers
United States48 participantsStarted 2012-02
Plain-language summary
Plague is an infectious disease of animals and humans caused by bacteria, Yersinia pestis. Modern antibiotics are effective against plague, but if an infected person is not treated promptly the disease is likely to cause illness or death. The purpose of this study is to evaluate at the safety, immunogenicity (bodily defense reaction), and tolerability of a new research vaccine. Up to 48 people will be enrolled in this study at the Center for Vaccine Development at Saint Louis University. Four groups of 12 volunteers will be given vaccine or placebo (inactive substance) one group at a time starting with the lowest dose working up to the highest dose. Shots will be given in the arm 2 times separated by 28 days. Study procedures include: physical exam, blood samples, and recording temperature and side effects in a memory aid. Participants will be involved in study related procedures for about 13 months.
Who can participate
Age range
18 Years – 45 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:
Inclusion criteria that must met prior to the initial vaccination:
* At least 18 and less than or equal to 45 years of age at the time of first vaccination.
* Never had plague or disease caused by Yersinia pestis.
* Able to provide informed consent.
* Read, signed, and dated informed consent document.
* Available for follow-up for the planned duration of the study.
* Satisfactory medical assessment with no clinically significant and relevant abnormalities as established by medical history and physical examination at screening.
* If the subject is female and of childbearing potential, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to each vaccination.
* If the subject is female and of childbearing potential, she agrees to use acceptable contraception and remain on the same method during the study as they were using prior to entering the study, and not become pregnant for 28 days following the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. Acceptable contraception methods are restricted to effective devices \[e.g., intrauterine device (IUD), NuvaRing®\] or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, a monogamous relationship with a vasectomized partner and abstinence from sexual intercourse with men.
* Negative enzyme-linked immunosorbent assay (ELISA) for human immunodeficiency vi…
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
Incidence of Grade 3 or above laboratory toxicities associated with vaccination for each dose group.
Timeframe: Through Day 42 (14 days after the second vaccination).
2
Incidence of serious adverse events (SAEs)associated with vaccination for each dose group.
Timeframe: Throughout the duration of the study (Visit 11, 365 + 14 days after the second vaccination or through termination visit, if terminated early).
3
Peak antibody titer [immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) for F1 and V antigen] for each dose group as determined by analysis of serum samples.
Timeframe: Days: 0, 14, 28, 42, 56, 68 and 208.
Trial details
NCT IDNCT01381744
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)