Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VRON-0200-AdC6 · 1 trial · 1 indication
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...
VRON-0200-AdC6 is an investigational monoclonal antibody being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in adults with chronic HBV who are on nucleos(t)ide therapy.
VRON-0200-AdC6 is being developed by Vir Biotechnology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for chronic Hepatitis B.
VRON-0200-AdC6 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants, indicating that enrollment has been completed.
VRON-0200-AdC6 is being studied in a Phase 1 clinical trial registered as NCT06070051. This is a dose-escalation prime/boost therapeutic vaccination study using two chimp adenoviral vectors in adults with chronic HBV on nucleos(t)ide therapy. The trial is active but not recruiting and has an enrollment of 56 participants.
VRON-0200-AdC6 is a monoclonal antibody designed to target chronic Hepatitis B. While the specific molecular target is not disclosed, the drug is being evaluated as a therapeutic vaccination approach in a prime/boost regimen using chimp adenoviral vectors to potentially elicit an immune response against the virus.