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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06070051 | Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy | PHASE1 | ACTIVE NOT_RECRUITING | 56 | — | — | Sep 26, 2023 | Mar 31, 2026 | May 30, 2025 | 3 | Hong Kong, New Zealand |
Number and percent of participants with 1 or more treatment-emergent adverse events within 28 days after the last dose by cohort.
Number and percent of participants with Grade 3 or higher local and/or systemic reactions within 28 days after the last dose by cohort.
Number and percent of participants with clinically significant changes from pre-vaccination laboratory values within 28 days after the last dose by cohort.
Number and percent of participants with serious adverse events within 6 months after the last dose by cohort.
Number and percent of participants with medically attended adverse events within 6 months after the last dose by cohort.
| Arm | Type | Description |
|---|---|---|
| Cohort 1a: Low Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost | EXPERIMENTAL | Participants assigned to Cohort 1a will receive a low dose prime vaccination of AdC7 vector on Day 1. They will receive a low dose boost vaccination of vector AdC6 on Day 91. |
| Cohort 1b: Low Dose VRON-0200-AdC6 Prime, No Boost | EXPERIMENTAL | Participants assigned to Cohort 1b will receive a low dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination. |
| Cohort 2a: High Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost | EXPERIMENTAL | Participants assigned to Cohort 2a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive a high dose boost vaccination of AdC6 vector on Day 91. |
| Cohort 2b: High Dose VRON-0200-AdC6 Prime, No Boost | EXPERIMENTAL | Participants assigned to Cohort 2b will receive a high dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination. |
| Cohort 3a: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, VRON-0200-AdC6 Boost | EXPERIMENTAL | Participants assigned to Cohort 3a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive VIR-2218 and VIR-3434 on Days 28, 56, 84, 112, 140, and 168. They will receive a high dose boost vaccination of AdC6 vector on Day 91. |
| Cohort 3b: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, No Boost | EXPERIMENTAL | Participants assigned to Cohort 3a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive VIR-2218 and VIR-3434 on Days 28, 56, 84, 112, 140, and 168. They will not receive a boost vaccination. |
| Name | Type | Description |
|---|---|---|
| VRON-0200-AdC6 | BIOLOGICAL | VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector |
| VRON-0200-AdC7 | BIOLOGICAL | VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector |
| VIR-2218 | DRUG | VIR-2218 given by subcutaneous injection |
| VIR-3434 | DRUG | VIR-3434 given by subcutaneous injection |
Inclusion Criteria: 1. Documented chronic HBV infection (eg, HBsAg+ ≥ 6 months with detectable HBsAg at screening) 2. Receipt of either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine for at least 12 months before screening with no reported anti...