RecruitingPrevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis
Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
Eligible age
18–55 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
Yes
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About this study
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
Sponsor: Dynavax Technologies Corporation
You may qualify if…
- ✓ 1. Adults 18 to 55 years of age
- ✓ 2. 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.
- ✓ 3. Able to comply with the protocol schedule and procedures
- ✓ 4. Able and willing to provide written informed consent
- ✓ 5. 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
- ✓ A premenopausal woman who has at least one of the following is considered not of childbearing potential:
- ✓ 1. Documented hysterectomy
- ✓ 2. Documented bilateral salpingectomy
You may not qualify if…
- ✕ 1. A history of plague disease or have previously received any plague vaccine
- ✕ 2. Active tuberculosis or other systemic infectious process
- ✕ 3. History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV
- ✕ 4. History of autoimmune disorder
- ✕ 5. History of sensitivity to any component of trial vaccines
- ✕ 6. Body mass index ≥ 30 kg/m2
- ✕ 7. Has received the following prior to any trial injection:
- ✕ a) ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG) b) ≤ 28 days: i) Any live vaccine ii) Any investigational medicinal agent c) ≤ 90 days: i) Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first trial vaccine administration or planned administration during the trial period. (For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent). Inhaled, topical, and intraarticular steroids are allowed.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07207408 · last updated 2026-06-18