Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rF1V-1018 · 2 trials · 4 indications
Evaluate adverse events
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
| Arm | Type | Description |
|---|---|---|
| Part 1 Arm 1 | EXPERIMENTAL | - |
| Part 1 Arm 2 | EXPERIMENTAL | - |
| Part 1 and Part 2: Arm 3 | EXPERIMENTAL | This Part 1 arm was selected for Part 2. |
| Part 1 and Part 2: Arm 4 | EXPERIMENTAL | This Part 1 arm was selected for Part 2. |
| Part 1 Arm 5 | EXPERIMENTAL | - |
| Part 1 Arm 6 | EXPERIMENTAL | - |
| rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered) | EXPERIMENTAL | Co-administration of rF1V vaccine and CpG 1018® adjuvant administered as 2 injections |
| rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix) | EXPERIMENTAL | Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered administered as 2 injections |
| rF1V vaccine only | EXPERIMENTAL | rF1V vaccine administered as 3 injections |
| Name | Type | Description |
|---|---|---|
| rF1V-1018 | BIOLOGICAL | Regimen 1 |
| rF1V vaccine | BIOLOGICAL | rF1V vaccine |
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 Da...
rF1V-1018 is an investigational vaccine being developed by Dynavax Technologies Corporation for the prevention of pneumonic plague resulting from aerosol exposure to Yersinia pestis. It is in Phase 2 clinical development and has not been approved by the FDA. It is studied in healthy adult volunteers aged 18 to 55 years.
rF1V-1018 is being studied for the prevention of pneumonic plague resulting from aerosol exposure to Yersinia pestis. The clinical program evaluates immunogenicity, safety, and tolerability in healthy adults. Because it remains investigational, it is not currently available as an approved preventive option outside of clinical trials.
Dynavax Technologies Corporation, which trades on Nasdaq under the ticker DVAX, is developing rF1V-1018. The company is running the Phase 2 clinical program evaluating the vaccine candidate for prevention of pneumonic plague resulting from aerosol exposure to Yersinia pestis.
rF1V-1018 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The program includes a completed Phase 2 trial and an active Phase 2 trial that is no longer recruiting participants.
rF1V-1018 has been studied in two Phase 2 trials. NCT05506969 is a completed Phase 2 trial of rF1V vaccine with CpG 1018 adjuvant compared with rF1V vaccine, enrolling 200 adults. NCT07207408 is an active Phase 2 trial of rF1V-1018 vaccine in adults 18 to 55 years of age, enrolling 148 participants in the United States.
rF1V-1018 is the Dynavax vaccine candidate that combines the rF1V antigen with the CpG 1018 adjuvant. A completed Phase 2 trial compared rF1V vaccine with CpG 1018 adjuvant against rF1V vaccine alone in adults 18 to 55 years of age, so the two names refer to related formulations studied in the same program.