Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05506969 | 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 | PHASE2 | COMPLETED | 200 | — | — | Aug 9, 2022 | Apr 26, 2024 | Jul 29, 2025 | 6 | United States |
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
| Arm | Type | Description |
|---|---|---|
| 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 | rF1V vaccine and CpG 1018® adjuvant |
| rF1V vaccine | BIOLOGICAL | rF1V vaccine |
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 wi...