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 for the prevention of pneumonic plague resulting from aerosol exposure to Yersinia pestis. It is intended for use in adults 18 to 55 years of age. The vaccine is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
rF1V-1018 is being developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DVAX. The company is conducting clinical trials to evaluate the vaccine's immunogenicity, safety, and tolerability in adult populations.
rF1V-1018 is in Phase 2 clinical development. Two Phase 2 trials have been initiated: one completed study (NCT05506969) and one actively recruiting study (NCT07207408). The vaccine remains investigational and has not received FDA approval for any indication.
rF1V-1018 is being evaluated in two Phase 2 clinical trials. NCT05506969, a completed study with 200 participants, compared the vaccine with CpG 1018 adjuvant to the vaccine alone in adults 18 to 55 years old. NCT07207408, currently recruiting 148 participants, assesses immunogenicity, safety, and tolerability in the same age group.
rF1V-1018 is a formulation of the rF1V vaccine that includes the CpG 1018 adjuvant. The completed trial NCT05506969 compared rF1V vaccine with CpG 1018 adjuvant against rF1V vaccine alone, indicating that rF1V-1018 is the adjuvanted version of the rF1V vaccine candidate.