VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the presentation of its abstract featuring data from one of the pivotal Phase 3 studies (PROTECT) evaluating Sci-B-Vac®, the company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, in an e-poster presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®, which took place on November 13, 2020.
Poster #: 0742
Title: A 3-antigen hepatitis B vaccine (3AV) provides consistently higher seroprotection rates (SPR) and anti-HBs titers compared to single-antigen vaccine in adults with comorbidities known to be associated with poor response to vaccinations: Results from the phase 3 double-blind, randomized study (PROTECT)
Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study delivered the poster presentation.
“In the PROTECT study, the overall immunogenicity of Sci-B-Vac was higher than that of Engerix-B in all study participants; this is demonstrated across key subgroup populations where Sci-B-Vac induced consistently higher seroprotection rates and higher mean concentrations of hepatitis B surface antibodies,” said Dr. Langley. “These subgroup data are significant, as there is an unmet medical need in certain populations, including adults over the age of 45 and those with underlying comorbidities, who have known reduced immune responses to single-antigen hepatitis B vaccines.”
The poster highlighted Sci-B-Vac’s ability to induce higher peak (Day 196) seroprotection rates (SPRs) and serum levels of HBV surface antibodies (anti-HBs titers) compared to Engerix-B, persistence and durability of which are believed to be dependent upon peak levels induced. The data included:
- Consistently higher SPRs induced in all subjects vaccinated with Sci-B-Vac compared to Engerix-B:
- In all subjects, age 18+ : 91.4% vs. 76.5% (difference: 14.9%)
- Adults 18-44 years : 99.2% vs. 91.1% (difference: 8.1%)
- Adults 45-64 years : 94.8% vs. 80.1% (difference: 14.7%)
- Adults 65+ : 83.6% vs. 64.7% (difference: 18.9%)
- These results were consistent across notable subgroups, including diabetics (83.3% vs. 58.3%) and obese individuals (89.2% vs. 68.1%)
- SPR is defined as the percent (%) of subjects who achieve anti-HBs titers ≥ 10 mIU/mL
- In all subjects, age 18+ : 91.4% vs. 76.5% (difference: 14.9%)
- Sci-B-Vac elicited higher geometric mean concentration (GMC) of anti-HBs titers in all subjects compared to Engerix-B:
- 6x higher GMC of anti-HBs titers in all adults age 18+ (1148.2 mIU/mL vs. 192.6 mIU/mL)
- 4-8x higher antibody GMCs were elicited in study subjects with Sci-B-Vac compared to Engerix-B regardless of age (65+ : 410.2 mIU/mL vs. 63.7 mIU/mL), obesity (884.0 mIU/mL vs. 110.0 mIU/mL), or diabetic status (222.3 mIU/mL vs. 41.3 mIU/mL)
A copy of the e-poster is available on the “Events/Presentations” page in the “Investors” section of VBI’s website.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, Sci-B-Vac®, which is approved for use and commercially available in Israel and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI’s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.
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