Phase 2
N=200
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Plague, Pneumonic · Plague · Vaccine-Preventable Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05506969 ↗Enrolled (actual)
200
Serious AEs
2.0%
Results posted
Jul 2025
Primary outcome: Primary: Rates of Reactogenicity and Safety — 16; 67; 57; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rF1V-1018 (Biological); rF1V vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dynavax Technologies Corporation
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Reactogenicity and Safety |
16; 67; 57; 0; 0; 2 | — |
Summary
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 to 55 years
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
Pre-existing stable medical condition means a subject 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 28 days prior to vaccination and has negative pregnancy tests just prior to vaccination and has agreed to continue adequate contraception until 28 days after last study injection. Adequate contraception is defined as a contraceptive method with a failure rate of 100.0°F at the time of vaccine administration.
- History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)
Data sourced from ClinicalTrials.gov (NCT05506969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.