Benzinga | May 12, 2021 10:16AM EDT

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

* VBI Vaccines Inc (NASDAQ: 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 ?g of VBI's 3-antigen vaccine candidate to 20 ?g of the single-antigen HBV vaccine, Engerix-B, made by GlaxoSmithKline Plc (NYSE: 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.

* Price Action: VBIV shares are trading 4.01% higher at $2.85 on the last check Wednesday.