(Reuters) – VBI Vaccines Inc said on Monday a late-stage study testing its hepatitis B vaccine against GlaxoSmithKline’s Engerix-B met its main goals.
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 the vaccine.
“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 Kuber