VBI Vaccines' Three-Antigen HBV Vaccine Candidate Trial Data Published In Lancet Infectious Diseases

VBI Vaccines Inc VBIV has announced that results from Phase 3 PROTECT trial of VBI's prophylactic 3-antigen hepatitis B (HBV) vaccine candidate in adults were published in The Lancet Infectious Diseases.
The study was designed to compare the immunogenicity and safety of 10 µg of VBI's 3-antigen vaccine candidate to 20 µg of the single-antigen HBV vaccine, Engerix-B, made by GlaxoSmithKline Plc GSK.
Results from this Phase 3 study include:
The seroprotection rate (SPR), defined as the percent of participants who achieved antibody (anti-HBs) titers above the protective threshold of 10 mIU/mL in patients over 45 years of age, was 91.4% for VBI's vaccine compared to 76.5% for Engerix-B at Day 196.
The SPR in adults over 45 years was 89.4% for VBI's vaccine vs. 73.1% for Engerix-B at Day 196, exceeding the pre-set margins for statistical superiority and clinical superiority.
In adults age 18-44 years, the SPR after two doses (Day 168) of VBI's vaccine was comparable to three doses of Engerix-B (Day 196) – 87.2% vs. 91.1%, respectively.
In all participants, VBI's vaccine elicited 6x higher Geometric Mean Concentration (GMC) of anti-HBs titers (1148.2 mIU/mL vs. 192.6 mIU/mL).
No safety signals were observed in either vaccine arm, and no new safety risks were identified.
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