Vaccine Info

VBI-2601 Hepatitis B Vaccine

Last Reviewed
February 10, 2021

VBI-2601 (BRII-179) Vaccine Description

VBI-2601 (BRII-179) is a therapeutic vaccine candidate that targets B- and T-cell immunity through several key mechanisms of action, including neutralizing circulation of the hepatitis B virus and blocking hepatocytes' infection Pre-S1 immunity, and enabling immune-mediated clearance of HBV-infected hepatocytes.

VBI Vaccines Inc. VBI-2601 is designed to impact the key extracellular steps in the HBV lifecycle to restore immunologic control over the infection.

VBI’s approach focuses on inducing and sustaining broad and effective immunity against hepatitis B.

Uniquely formulated to target both B-cell and T-cell immunity through multiple action mechanisms, including neutralization of the circulating hepatitis B virus, blocking hepatitis B infection of hepatocytes mediated through Pre-S1, and enabling immune-mediated clearance of HBV-infected hepatocytes.  Where many investigational agents work inside the infected liver cells downstream of transcription, BRII-179 is designed to impact the key extracellular steps in the HBV lifecycle to sustain immunologic control over the infection.

VBI believes VBI-2601 has the unique potential to do this by targeting B- and T-cell immunity through several key mechanisms of action, including neutralizing circulation of the hepatitis B virus and blocking hepatocytes' infection Pre-S1 immunity, and enabling immune-mediated clearance of HBV-infected hepatocytes, says the company.

VBI-2601 and BRII-179 Vaccine History

VBI has entered into a license and collaboration agreement with Brii Bio (“Brii”). Under the agreement, VBI and Brii will collaborate in developing the product through to completion of a proof-of-concept clinical trial in China, following which Brii Bio will be responsible for funding all development in the licensed territory. Brii Bio will retain commercial rights in the approved territory, while VBI will have all rights outside of the licensed territory.

“These early data from the low-dose cohorts are very encouraging and provide a human proof-of-concept that leads us to believe VBI-2601 (BRII-179) could be an effective and critical component of a functional cure for chronic hepatitis B patients,” said Jeff Baxter, VBI’s President, and CEO, in a press release issued on November 18, 2020.

“A functional cure for chronic hepatitis B is likely to require multiple components sufficient to (1) drive down HBV DNA, (2) drive down immunosuppressive HBV surface antigen, and (3) induce or restore HBV-specific long-term immunologic control against HBV infection. This study was designed to assess the ability of VBI-2601 (BRII-179) to induce or restore antibody and T cell responses against HBV. Responses seen to-date rarely occur in the natural history of this chronically-infected population. We are exploring various combinations of VBI-2601 (BRII-179) with other therapeutic modalities for the next phase of development to achieve a functional cure.”

This study (ACTRN12619001210167) was conducted by our partner Brii Biosciences. Based on this study's results, Brii Biosciences plans to conduct additional combination studies of VBI-2601 (BRII-179) within Asia-Pacific Economic Cooperation and the more significant China areas, said the company.

VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.

With operations in the People's Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world.

VBI-2601 (BRII-179) Vaccine Indication

VBI-2601 is indicated as the functional cure for treating chronic hepatitis B infection. Hepatitis B infection is the most prevalent global infection, with 250 million infected worldwide. 

Not only is global HBV infection rampant, but there is also a high unmet need for effective therapies, as current treatments generate a functional cure in less than 10 percent of those treated. Achieving a functional cure, therefore, is a global health priority.

VBI-2601 (BRII-179) Vaccine Dosage

The phase 1/2 study is a two-part dose-escalation study assessing a low dose and a high dose of VBI-2601 (BRII-179), with and without an undisclosed adjuvant, and has enrolled 46 patients.

BRII-179 (VBI-2601) was given by intramuscular injection.

VBI-2601 (BRII-179) Vaccine Update

December 17, 2020 - Interim data from a Phase 1b/2a trial designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic, demonstrated the induction of both antibody and T cell responses in chronically infected HBV patients. The Company announced that recruitment was completed for a Phase 2 clinical trial for BRII-835 (VIR-2218), a novel, investigational RNA interference (RNAi) therapeutic designed to inhibit the expression of all HBV proteins, including hepatitis B surface antigen (HBsAg). Interim results are expected in the second quarter of 2021. During the first quarter of 2021, the Company is also preparing to launch a Phase 2 clinical trial examining the safety and efficacy of BRII-179 and BRII-835 in combination with patients on the stable nucleus (t)ide therapies.

November 18, 2020 - VBI Vaccines Inc. announced positive interim clinical results from the ongoing Phase 1b/2a study of VBI-2601 (BRII-179), a novel recombinant, protein-based immunotherapeutic candidate for the treatment of chronic hepatitis B virus infection, in development in collaboration with Brii Biosciences.

November 14, 2019 - VBI Vaccines Inc. and Brii Biosciences (“Brii Bio”) announced the first patient dosed in Phase 1b/2a proof-of-concept study of BRII-179 (VBI-2601), a novel recombinant, a protein-based immuno-therapeutic candidate in development for the treatment of chronic hepatitis B virus infection.

VBI-2601 (BRII-179) Vaccine Clinical Trial

Clinical Trial ACTRN12619001210167: A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B

  • A Phase 1b/2a clinical study of BRII-179 (VBI-2601) is a randomized, controlled study designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601) in patients with chronic HBV infection. 
  • The low-dose cohorts of the ongoing two-part Phase 1b/2a evaluated VBI-2601 (BRII-179), unadjuvanted and adjuvanted, in combination with a nucleus(t)ide analog (NUC) therapy, intended to reduce HBV DNA, vs. NUC therapy only, in chronically-infected HBV patients.
  • Objectives of this early-stage study were to elicit immunologic responses known to be associated with functional immunity against HBV infection, including the stimulation of T cell immunity and the induction of antibody responses to HBV surface antigens (S, Pre-S1, Pre-S2).