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VBI's hepatitis B vaccine matches GSK's Engerix-B in late-stage study

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VBI's hepatitis B vaccine matches GSK's Engerix-B in late-stage study

VBI Vaccines Inc. said its hepatitis B vaccine Sci-B-Vac performed as well as GlaxoSmithKline PLC's Engerix-B in producing an immune response in patients with the disease as part of a late-stage study.

For the main goal of the phase 3 study, named Constant, the Cambridge, Mass.-based biotech was assessing the lot-to-lot consistency for immune response, as measured by geometric mean concentration of antibodies across three independent, consecutively manufactured lots of Sci-B-Vac, four weeks after the third vaccination.

The study's secondary goal was a non-inferior immune response versus Engerix-B as measured by seroprotection rates — the percentage of patients that yield a positive reading for antibodies capable of preventing infection — for patients receiving the vaccines at day 196. Subjects vaccinated with Sci-B-Vac had 99.3% seroprotection rates compared to 94.8% for those who received Engerix-B.

VBI Vaccines expects to begin regulatory submissions for the vaccine in the U.S., Canada and Europe in the second half of the year.

The company's share price was up 11.76% to $1.52 as of 11:23 a.m. ET on Jan. 9.