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This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.
VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment.
VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRIVE: Cohort 1a (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total |
|
| STRIVE: Cohort 2a (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total |
|
| STRIVE: Cohort 3a (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total |
|
| STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total |
|
| STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | Experimental | Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-3434 | Drug | VIR-3434 given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 96 weeks | |
| STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment | Up to 48 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Clichy | 92110 | France | |||
| Investigative Site |
Participants were not enrolled in Cohort 1a, 2a,3a, 5a and 1b Arms/Groups
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| ID | Title | Description |
|---|---|---|
| FG000 | STRIVE: Cohort 1a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| FG001 | STRIVE: Cohort 2a (VIR-3434 + TDF) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: PREVAIL | Oct 11, 2022 | Oct 15, 2025 |
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| THRIVE: Cohort 1b (VIR-3434 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks |
|
| THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | Experimental | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total |
|
|
| VIR-2218 | Drug | VIR-2218 given by subcutaneous injection |
|
|
| TDF | Drug | TDF given orally |
|
| PEG-IFNα | Drug | PEG-IFNα given by subcutaneous injection |
|
| STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment | Up to 72 weeks |
| STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study | Up to 96 weeks |
| STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study | Up to 96 weeks |
| STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study | Up to 96 weeks |
| STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL) | Up to 96 weeks |
| STRIVE and THRIVE: Proportion of Participants With HBsAg Loss With Anti-HBs Seroconversion at End of Treatment and at 24 Weeks Post-end of Treatment | Up to 76 weeks |
| STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit | Up to 96 weeks |
| STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment | Up to 72 weeks |
| STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit | Up to 96 weeks |
| STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion | Up to 72 weeks |
| STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434 | Up to 96 weeks |
| STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study | Up to 96 weeks |
| STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study | Up to 96 weeks |
| STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study | Up to 96 weeks |
| THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks | Up to 92 weeks |
| THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment | Up to 44 weeks |
| THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks | Up to 68 weeks |
| THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434 | Up to 92 weeks |
| THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study | Up to 92 weeks |
| THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) | Up to 92 weeks |
| Nice |
| 06200 |
| France |
| Investigative Site | Rennes | 35000 | France |
| Investigative Site | Toulouse | 31000 | France |
| Investigative Site | Hong Kong | Sha Tin | Hong Kong |
| Investigative Site | Hong Kong | Hong Kong |
| Investigative Site | Chisinau | MD 2025 | Moldova |
| Investigative Site | Bucharest | 021105 | Romania |
| Investigative Site | Busan | 49241 | South Korea |
| Investigative Site | Seoul | 5505 | South Korea |
| Investigative Site | Yangsan | 50612 | South Korea |
| Investigative Site | Glasgow | G4 0SF | United Kingdom |
| Investigative Site | London | EC1A 7BE | United Kingdom |
| Investigative Site | London | SE5 9RS | United Kingdom |
| Investigative Site | Manchester | M8 5RB | United Kingdom |
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| FG002 | STRIVE: Cohort 3a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| FG003 | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally |
| FG004 | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally PEG-IFNα: PEG-IFNα given by subcutaneous injection |
| FG005 | THRIVE: Cohort 1b (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| FG006 | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally |
| COMPLETED |
|
| NOT COMPLETED |
|
cohort 1a, 2a,3a, 5a and 1b were not open for enrollment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | STRIVE: Cohort 1a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| BG001 | STRIVE: Cohort 2a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| BG002 | STRIVE: Cohort 3a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| BG003 | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally |
| BG004 | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally PEG-IFNα: PEG-IFNα given by subcutaneous injection |
| BG005 | THRIVE: Cohort 1b (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally |
| BG006 | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Hepatitis B surface antigen (Log10 IU/mL) | Mean | Standard Deviation | Log10 IU/mL |
| |||||||||||||||
| Hepatitis B e antigen status | Count of Participants | Participants |
| ||||||||||||||||
| Alanine Aminotransferase (U/L) | Mean | Standard Deviation | U/L |
| |||||||||||||||
| Hepatitis B Virus DNA (Log10 IU/mL) | Mean | Standard Deviation | Log10 IU/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment | Cohort 1a, 2a, 3a,5a and 1b was not opened for enrollment | Posted | Count of Participants | Participants | Up to 48 weeks |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment | Not Posted | Up to 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment | Not Posted | Up to 72 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL) | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE and THRIVE: Proportion of Participants With HBsAg Loss With Anti-HBs Seroconversion at End of Treatment and at 24 Weeks Post-end of Treatment | Not Posted | Up to 76 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment | Not Posted | Up to 72 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at the F48 Follow-Up Visit | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion | Not Posted | Up to 72 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434 | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study | Not Posted | Up to 96 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks | Not Posted | Up to 92 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment | Not Posted | Up to 44 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks | Not Posted | Up to 68 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434 | Not Posted | Up to 92 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study | Not Posted | Up to 92 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) | Not Posted | Up to 92 weeks | Participants |
48 Weeks
Data reported at only through primary end point collection date and final study adverse events data will be reported with final results
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STRIVE: Cohort 1a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | STRIVE: Cohort 2a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | STRIVE: Cohort 3a (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF) | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally | 0 | 0 | 0 | 16 | 11 | 16 |
| EG004 | STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα) | Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally PEG-IFNα: PEG-IFNα given by subcutaneous injection | 0 | 16 | 0 | 0 | 0 | 0 |
| EG005 | THRIVE: Cohort 1b (VIR-3434 + TDF) | Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks VIR-3434: VIR-3434 given by subcutaneous injection TDF: TDF given orally | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF) | Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total VIR-3434: VIR-3434 given by subcutaneous injection VIR-2218: VIR-2218 given by subcutaneous injection TDF: TDF given orally | 0 | 17 | 1 | 17 | 12 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Immediate post-injection reaction | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Excessive eye blinking | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Alpha 1 foetoprotein increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
|
Investigators may present or publish results after:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Vir Biotechnology, Inc. | 415-654-5281 | clinicaltrials@vir.bio |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: STRIVE | Dec 14, 2023 | Oct 15, 2025 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: THRIVE | Jan 26, 2024 | Oct 15, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2025 | Oct 15, 2025 | SAP_003.pdf |
Not provided
| 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 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| THRIVE: Cohort 2b |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South Korea |
|
| Romania |
|
| Hong Kong |
|
| United Kingdom |
|
| Moldova |
|
| France |
|
| Thailand |
|
| THRIVE: Cohort 2b |
|
| HBeAg negative |
|
| THRIVE: Cohort 2b |
|
| THRIVE: Cohort 2b |
|