VBI Vaccines shares rise on late-stage hepatitis B vaccine study data
May 12, 2021 8:34 AM ETVBI Vaccines Inc. (VBIV)By: Aakash Babu, SA News Editor2 Comments VBI Vaccines (NASDAQ:VBIV) shares rise more than 2% during premarket trading after results from the company's pivotal Phase 3 study of prophylactic 3-antigen hepatitis B (HBV) vaccine candidate in adults were published in The Lancet Infectious Diseases journal. 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. It enrolled 1,607 adults age ≥ 18, with study participants being randomized 1:1 to receive a 3-dose regimen of either 10 µg of VBI’s 3-antigen vaccine, or 20 µg of Engerix-B, given at Days 0, 28, and 168. In the study, 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 participants ≥ 18 years was 91.4% for VBI’s vaccine compared to 76.5% for Engerix-B at Day 196. The SPR in adults ≥ 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. The safety and tolerability seen in the study were consistent with safety data from previous clinical studies – no safety signals observed in either vaccine arm, and no new safety risks identified, the company said.
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