Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age (NCT07207408) | Clinical Trial Compass
RecruitingPhase 2
Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
United States148 participantsStarted 2025-09-11
Plain-language summary
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
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
. Adults 18 to 55 years of age
. Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.
. Able to comply with the protocol schedule and procedures
. Able and willing to provide written informed consent
. If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through three months following the final trial injection
. Documented hysterectomy
. Documented bilateral salpingectomy
. Documented bilateral oophorectomy
Exclusion criteria
. A history of plague disease or have previously received any plague vaccine
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
Anti-rF1V antibody level
Timeframe: 4 weeks after final study vaccine
2
Evaluate safety of rF1V-1018
Timeframe: injection reactions through 7 days after each study vaccine, adverse events for 28 days after each study vaccine; SAEs, MAEs, imAESIs through 6 months after the final study vaccine
Trial details
NCT IDNCT07207408
SponsorDynavax Technologies Corporation
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-01-29
Contact for this trial
Ouzama Henry, MD, Vice President, Clinical Development