rF1V-1018 vaccine for pneumonic plague prevention in adults 18–55
Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
This trial will test whether different doses and schedules of the rF1V-1018 vaccine are safe and produce immune responses that could protect healthy adults aged 18–55 against pneumonic plague from aerosol Yersinia pestis exposure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Dynavax Technologies Corporation Industry-sponsored |
| Drugs / interventions | nirsevimab, teplizumab, evinacumab, obinutuzumab, chemotherapy, prednisone |
| Locations | 3 sites (Miami, Florida and 2 other locations) |
| Trial ID | NCT07207408 on ClinicalTrials.gov |
What this trial studies
This is a dose-finding, two-part Phase 2 trial testing multiple doses and regimens of the rF1V-1018 vaccine in healthy adults aged 18–55. In Part 1 up to six dose regimens will be evaluated and up to two regimens will be chosen to continue into Part 2. Blood samples for immunogenicity and routine safety assessments will be collected at scheduled visits over the course of the trial. Participants will return for periodic clinic visits for injections (as assigned), blood draws, and safety monitoring through the end of the study.
Who should consider this trial
Good fit: Healthy adults 18–55 years old or those with stable chronic conditions who are able to attend clinic visits, comply with study procedures, and provide informed consent are ideal candidates.
Not a fit: People outside the 18–55 age range, pregnant women, or those who are immunocompromised or unable to follow the visit schedule are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the vaccine could provide a safe way to stimulate protective immunity against pneumonic plague in exposed adults.
How similar studies have performed: Recombinant F1/V vaccine approaches and adjuvants like 1018 have produced immune responses in preclinical and early human studies, but there is not yet a widely used licensed human plague vaccine.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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
3. Documented bilateral oophorectomy
4. Documented and current bilateral tubal ligation or occlusion
Exclusion Criteria:
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.
ii) Granulocyte or granulocyte-macrophage colony stimulating factor iii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by-case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor) iv) Antisense oligonucleotides v) Drugs/investigational agents with very long half-lives (defined as ≥ 60 days) (eg, radioactive iodine, amiodarone, liraglutide, nirsevimab, teplizumab, evinacumab, and obinutuzumab) vi) Infusion of blood products d) At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells
8. If female is pregnant (known before or established at the time of screening), breastfeeding, or planning breastfeeding or a pregnancy
9. Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
10. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
11. Oral temperature ≥ 38°C (≥ 100.4°F) at the time of vaccine administration
12. History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)
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Where this trial is running
Miami, Florida and 2 other locations
- AMR- Miami — Miami, Florida, United States (Not_yet_recruiting)
- AMR- El Dorado — El Dorado, Kansas, United States (Recruiting)
- AMR- Las Vegas — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: Ouzama Henry, MD, Vice President, Clinical Development
- Email: ohenry@dynavax.com
- Phone: 510-848-5100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.