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| Name | Class |
|---|---|
| Vir Biotechnology, Inc. | INDUSTRY |
| VBI Vaccines Inc. | INDUSTRY |
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This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Participants will receive BRII-835 (VIR-2218) for 32 weeks |
|
| Cohort B | Experimental | Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40 |
|
| Cohort C | Experimental | Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRII-835 (VIR-2218) | Drug | BRII-835 (VIR-2218) will be given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal | up to Week 96 | |
| Number of participants with Adverse Events (AE) | up to Week 96 | |
| Number of participants with Serious Adverse Events (SAE) | up to Week 96 | |
| Number of participants with abnormalities in clinical laboratory tests | up to Week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofei Chen | Brii Biosciences Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 61002 | Kingswood | New South Wales | 2747 | Australia | ||
| Investigative Site 61001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40043858 | Derived | Ji Y, Le Bert N, Lai-Hung Wong G, Douglas MW, Lee A, Zhu C, Wang B, Lv J, Li D, Tan Y, Ma H, Chen J, Chen X, Zhu Q, Yuen MF, Bertoletti A. The Impact of Hepatitis B Surface Antigen Reduction via Small Interfering RNA Treatment on Natural and Vaccine (BRII-179)-Induced Hepatitis B Virus-Specific Humoral and Cellular Immune Responses. Gastroenterology. 2025 Jul;169(1):136-149. doi: 10.1053/j.gastro.2025.02.016. Epub 2025 Mar 3. |
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| BRII-179 (VBI-2601) with IFN-α | Biological | BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection |
|
| BRII-179 (VBI-2601) | Biological | BRII-179 (VBI-2601) will be administered by intramuscular injection |
|
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| Investigative Site 61004 | Herston | Queensland | 4029 | Australia |
| Investigative Site 88602 | Changhua, Taiwan | 500 | China |
| Investigative Site 85201 | Hong Kong | China |
| Investigative Site 85202 | Hong Kong | China |
| Investigative Site 85203 | Hong Kong | China |
| Investigative Site 88601 | Kaohsiung, Taiwan | 83301 | China |
| Investigative Site 88604 | Kaohsiung, Taiwan | China |
| Investigative Site 85204 | NEW Territories, Hong Kong | China |
| Investigative Site 88603 | Taichung, Taiwan | 40447 | China |
| Investigative Site 88605 | Taipei CITY | 10048 | China |
| Investigative Site 64002 | Dunedin Central | Dunedin | 9016 | New Zealand |
| Investigative Site 64001 | Auckland | 2025 | New Zealand |
| Investigative Site 65001 | Singapore | 169608 | Singapore |
| Investigative Site 65002 | Singapore | 529889 | Singapore |
| Investigative Site 82004 | Busan | 49241 | South Korea |
| Investigative Site 82003 | Seongnam-si, Gyeonggi-do | 13496 | South Korea |
| Investigative Site 82001 | Seoul | 3080 | South Korea |
| Investigative Site 82005 | Seoul | 3722 | South Korea |
| Investigative Site 82002 | Seoul | 5505 | South Korea |
| Investigative Site 66001 | Bangkok | 10330 | Thailand |
| Investigative Site 66003 | Chiang Mai | 50200 | Thailand |
| Investigative Site 66002 | Khon Kaen | 40002 | Thailand |
| Investigative Site 66005 | Nonthaburi | 11000 | Thailand |
| Investigative Site 66006 | Nonthaburi | 11000 | Thailand |
| Investigative Site 66004 | Pathum Thani | 12120 | Thailand |
| Investigative Site 66007 | Songkhla | 90110 | Thailand |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 18, 2026 | 15 | ||
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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