VBI Hepatitis B Vaccine Meets Main Goals in Late-Stage Trial

By Reuters Staff

June 18, 2019

(Reuters) - VBI Vaccines Inc said on Monday a late-stage study testing its hepatitis B vaccine against GlaxoSmithKline's Engerix-B in adults 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.

At four weeks after the third vaccination (at day 196), the seroprotection rate (anti-HBsAg levels ≥ 10 mIU/mL) in all patients over age 18 who received Sci-B-Vac was 91.4% compared with 76.5% for those who received Engerix-B, the company said.

The seroprotection rate after three vaccinations was also higher with Sci-B-Vac in subjects age 45 and older (89.4% vs 73.1% with Engerix-B); similar advantages were also seen in diabetics and obese patients.

"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.

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.