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 range18 Years – 55 Years

SexALL

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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
✕. Active tuberculosis or other systemic infectious process
✕. History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV
✕. History of autoimmune disorder
✕. History of sensitivity to any component of trial vaccines
✕. Body mass index ≥ 30 kg/m2
✕. Has received the following prior to any trial injection:
✕. If female is pregnant (known before or established at the time of screening), breastfeeding, or planning breastfeeding or a pregnancy

What they're measuring

Anti-rF1V antibody level

Timeframe: 4 weeks after final study vaccine

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 completion2026-05-29

Contact for this trial

Ouzama Henry, MD, Vice President, Clinical Development

510-848-5100 ohenry@dynavax.com

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