The trial administered VBI's Sci-B-Vac at a 10 microgram dose
against a 20 microgram dose of Engerix-B, a vaccine which was first
approved in the United States in 1989.
Hepatitis B, a viral infection that attacks the liver, is spread by
contact with the blood or bodily fluids of an infected person. The
World Health Organization estimates 257 million people are living
with hepatitis B virus infection.
The seroprotection rate in all patients aged 18 and older who
received Sci-B-Vac was 91.4% compared with 76.5% for those who
received Engerix-B, the company said.
Seroprotection rate is a measure of clinical protection provided by
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"We remain on track to submit applications for regulatory approvals
in the U.S., Europe, and Canada beginning mid-year 2020," Chief
Executive Officer Jeff Baxter said in a statement.
However, the company said the study did not meet a secondary goal of
demonstrating two doses of Sci-B-Vac were non-inferior to three
doses of Engerix-B in all patients 18 and above.
Sci-B-Vac is also being studied in another late-stage trial, whose
results are expected by the year end.
(Reporting by Tamara Mathias in Bengaluru; Editing by Shailesh
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