VBI Vaccines Announces Publication of Results from a Phase 4 Study of VBI’s Prophylactic 3-Antigen Hepatitis B Vaccine in Vaccine
CAMBRIDGE, Mass.: VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that results from a Phase 4 study of VBI’s prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier. The study was designed to evaluate the immunogenicity of VBI’s 3-antigen HBV vaccine in support of the qualification of that batch as a new reference standard for vaccine release to the Israeli market, where VBI’s vaccine is available as Sci-B-Vac®.
“In this Phase 4 study, our 3-antigen HBV vaccine once again demonstrated robust immunogenicity with no additional safety signals observed,” said Dr. Francisco Diaz-Mitoma, VBI’s Chief Medical Officer. “The rapid onset of protection seen in this study may be particularly relevant to younger adults who need protection quickly, including healthcare workers and travelers. We believe our vaccine could be a meaningful intervention in the fight to eliminate hepatitis B and we look forward to working with the U.S. Food and Drug Administration and the European Medicines Agency in 2021 as part of the licensure process to expand access to this vaccine outside of Israel.”
Prior to market release in Israel, batches of VBI’s vaccine are tested against a reference vaccine batch that has been assessed in a clinical trial. According to the European Pharmacopeia, the reference batch should elicit, after the full course of vaccination, a seroprotection rate (SPR) of at least 95% in young and healthy adult participants. In this open-label, single-arm Phase 4 study in 91 healthy adults age 20-40 years, this objective was achieved two months after the second dose – the SPR at month 3 was 98.8% [95% CI: 93.7%, 99.7%]. SPR is defined as the percent of participants who achieve antibody titers (anti-HBs titers) above the protective threshold of 10 mIU/mL.
Additional results from this Phase 4 study include:
- By month 7, after receiving three doses, all enrolled participants (100%) were seroprotected
- The majority of participants were high responders, defined as achievement of anti-HBs titers ≥ 100 mIU/mL – high-responder SPR was 81.4% and 97.6% at month 3 (after 2 doses) and month 7 (after 3 doses), respectively
- The geometric mean concentration (GMC) of anti-HBs titers were also substantially above the protective threshold at 413.6 mIU/mL and 6799.9 mIU/mL at month 3 and month 7, respectively
- Anti-HBs titers were maintained above 2000 mIU/mL at month 12, suggesting a potent and sustained response
- Consistent with other clinical data, VBI’s 3-antigen HBV vaccine was well-tolerated with no safety signals observed
Participants in this study were immunized with 10 µg of VBI’s HBV vaccine at months 0, 1, and 6.
