(Add details about the test results, background)
June 17 (Reuters) – VBI Vaccines Inc. announced Monday that a final-phase study to test its GlaxoSmithKline-based hepatitis B vaccine against Engerix-B had achieved its primary goals.
The trial administered Sci-B-Vac from VBI at a dose of 10 micrograms against a dose of 20 micrograms of Engerix-B, a vaccine 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 body fluids of an infected person. The World Health Organization estimates that 257 million people live with the hepatitis B virus.
The seroprotection rate in all patients aged 18 years and older who received Sci-B-Vac was 91.4%, compared to 76.5% for those who received Engerix-B, the company said.
The seroprotection rate is a measure of the clinical protection provided by the vaccine.
"We remain on track to submit regulatory approval applications in the US, Europe and Canada starting in mid-2020," said CEO Jeff Baxter. in a statement.
However, the company said that the study had not reached the secondary goal of demonstrating that two doses of Sci-B-Vac were not inferior to three doses. Engerix-B in all patients 18 years and older.
Sci-B-Vac is also being studied in another advanced phase trial, the results of which are expected by the end of the year. (Report by Tamara Mathias in Bengaluru, edited by Shailesh Kuber)