VBI hepatitis B vaccine meets main goals in late-stage trial
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 WHO 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," a researcher 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.
Hepatitis B, a viral infection that attacks the liver, is spread by contact with the blood or bodily fluids of an infected person. The WHO 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," a researcher 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.
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Labels: attacks, blood, bodily fluids, hepatitis B vaccine, infected person, LIVER, seroprotection, spread by contact with, viral infections
posted by G S Iyer at 4:25 AM
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