Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

May 27, 2025 updated by: University Health Network, Toronto

Phase II Investigator-Initiated Study to Understand the Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection

This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.

The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body.

This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the vaccinal effect of VIR-3434 in chronic HBeAg-negative hepatitis B (CHB) patients suppressed on nucleos(t)ide analogue therapy. Total 15 patients will be enrolled at single site.

The participants will receive VIR-3434 300 mg subcutaneous injection every 4 weeks x 48 weeks and then follow up for 48 weeks. Total three Fine-needle aspiration (FNA) procedure will be performed during the study: before treatment, 3 days after the first injection and 3 days after the week24 injection.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2C4
        • Recruiting
        • University Health Network
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 to ≤65 years
  2. Chronic HBV infection with evidence of HBsAg-positivity x > 6 months
  3. Quantitative HBsAg 300 - 10,000 IU/mL
  4. On stable nucleos(t)ide therapy >1 year
  5. HBV DNA < 60 IU/mL on 2 occasions at least 12 weeks apart
  6. ALT ≤ 45 U/L on 2 occasions at least 12 weeks apart
  7. Female subjects must have a negative pregnancy test or confirmation of postmenopausal status. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception 14 days before study drug administration through the study participation. Female subjects must also agree to refrain from egg donation and in vitro fertilization from the time of study drug administration through the study participation.
  8. Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study drug administration through the study participation: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP. Male subjects must also agree to not donate sperm from the time of study drug administration through the study participation.
  9. Able and willing to sign informed consent

Exclusion Criteria:

  1. History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)
  2. History of or current hepatocellular carcinoma
  3. Hepatitis C Virus (HCV) RNA or anti-Hepatitis D Virus (HDV) positive
  4. HIV co-infection
  5. Pregnancy or lactation
  6. Alanine Aminotransferase (ALT) > 45 U/L
  7. History of chronic liver disease other than HBV aside from fatty liver documented only on US
  8. Use of peginterferon therapy for HBV infection within past 12 months
  9. Use of chronic immunosuppressive medications at a dose equivalent to 10 mg daily of prednisone or greater within past 6 months
  10. Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than non-melanoma skin cancer in previous 5 years, immunodeficiency syndrome
  11. Subject has received any investigational drug (including any investigational vaccines) within 90 days or 5 half-lives (whatever is longer) before screening for this study or is currently enrolled in an investigational study
  12. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments, such as liver FNAs
  13. Platelet count < 120,000,000,000/L
  14. The International Normalised Ratio (INR) > 1.3
  15. Bilirubin > 40 µmol/L
  16. Hemoglobin < 110 g/dL for women or 120 g/dL for men
  17. estimated Glomerular Filtration Rate (eGFR) < 45 cc/min
  18. Alpha Fetoprotein (AFP) > 50 ng/mL
  19. Prior liver or other solid organ transplantation
  20. Patients on anticoagulation therapy or with any bleeding diathesis
  21. Patients with hemoglobinopathy (thalassemia, sickle cell disease etc)
  22. Other significant liver disease: alcoholic liver disease, autoimmune hepatitis, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson Disease or alpha-1 antitrypsin deficiency - as documented in clinical history
  23. Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIR-3434
VIR-3434 300 mg subcutaneous injection every 4 weeks*48 weeks
Drug: VIR-3434
VIR-3434 is a human monoclonal antibody that binds the antigenic loop present in all forms of the surface envelope protein (small, middle, and large HBsAg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in log Quantitative HBsAg
Time Frame: from baseline through study completion, an average of 2 year
from baseline through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute and change of Hepatitis B Virus (HBV) RNA
Time Frame: from baseline through study completion, an average of 2 year
from baseline through study completion, an average of 2 year
Absolute and change of HBV core-related Ag
Time Frame: from baseline through study completion, an average of 2 year
from baseline through study completion, an average of 2 year
Proportion of subjects with HBsAg loss
Time Frame: from baseline through study completion, an average of 2 year
from baseline through study completion, an average of 2 year
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) with study treatment
Time Frame: from baseline through study completion, an average of 2 year
Frequency of AEs and SAEs with VIR-3434 administration in combination with NA therapy for CHB
from baseline through study completion, an average of 2 year
Frequency of AEs and SAEs due to hepatic FNA
Time Frame: from baseline through study completion, an average of 2 year
from baseline through study completion, an average of 2 year
HBeAg seroconversion
Time Frame: from baseline through study completion, an average of 2 year
Proportion of subject with HBeAg seroconversion
from baseline through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jordan Feld, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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