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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04607850 | Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions | PHASE1 | COMPLETED | 108 | — | — | Mar 16, 2021 | Jan 16, 2024 | Aug 28, 2025 | 16 | Belgium, Estonia +1 |
Measure of adverse events, serious adverse events (SAEs), ≥Grade 3 study vaccine-related adverse events reported.
| Arm | Type | Description |
|---|---|---|
| Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^7 pfu) |
| Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu) |
| Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10) vp and MVA-HPV (1 x 10\^8 pfu) |
| Group 1 ChAdOx1-HPV mid dose and MVA-HPV low dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu) |
| Group 2 ChAdOx1-HPV high dose and MVA-HPV low dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^7 pfu) |
| Group 3 ChAdOx1-HPV low dose and MVA-HPV high dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^8 pfu) |
| Group 4 ChAdOx1-HPV mid dose and MVA-HPV high dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^8 pfu) |
| Group 5 ChAdOx1-HPV high dose and MVA-HPV high dose | EXPERIMENTAL | Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^8 pfu) |
| Group 6 Placebo Saline | PLACEBO_COMPARATOR | Sodium Chloride (0.9%) |
| Name | Type | Description |
|---|---|---|
| ChAdOx1-HPV | BIOLOGICAL | Trial vaccine |
| MVA-HPV | BIOLOGICAL | Trial vaccine |
| Placebo | BIOLOGICAL | Saline placebo vaccine |
Inclusion Criteria: 1. Females aged ≥25 and ≤55 years of age at screening. 2. Persistent hrHPV infection defined as a documented cervical infection with hrHPV type(s) in the 6 to 18 months prior to screening and confirmed at screening (participants in the main and expansion phases only). Participan...