Hepatitis B vaccine meets main goals in late-stage study

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VBI Vaccines has announced that a late-stage study testing its hepatitis B vaccine against GlaxoSmithKline’s Engerix-B met its main goals, reports Reuters Health. 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 US in 1989.

The report says 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 Organisation estimates 257m 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 US, Europe, and Canada beginning mid-year 2020,” CEO Jeff Baxter is quoted in the report as saying.

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, the report said.

Reuters Health report

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