Key Phase 3 Clinical Results of New Hepatitis B Vaccine Sci-B-Vac Published

On May 12, 2021, VBI Vaccines (hereinafter referred to as VBI) announced that the key phase 3 clinical trial data of its preventive 3-antigen hepatitis B virus (HBV) vaccine candidate in adults was published in The Lancet Infectious Diseases.

Hepatitis B is one of the most important infectious disease threats in the world, with more than 290 million infected people worldwide.

Although the current HBV vaccination program effectively solves the problem of infants, there is a huge immune gap in certain adult groups, largely due to the poor immune response of many risk groups, such as the elderly, diabetes or kidney disease Patients, overweight adults and smokers.

Sci-B-Vac is the third-generation hepatitis B vaccine developed by VBI.

This phase 3 study is a randomized, controlled, double-blind trial conducted across 28 research centers in 4 countries.

Among 18-44-year-old adults, the seroprotection rate (SPR) after 2 VBI vaccination (Day 168) was 87.

Compared with the control group, regardless of age, body mass index or diabetes status, subjects who received the VBI vaccine had a higher SPR, and the antibody GMC was 5-8 times that of the control group.

Among subjects over 45 years of age, the SPR at day 196 after the VBI vaccine candidate was 89.

The safety and tolerability are consistent with the safety data of previous clinical studies.

Note: The original text has been deleted

Reference materials:

[1] VBI Vaccines Announces Publication of Results from Pivotal Phase 3 Study, PROTECT, of VBI's Prophylactic 3-Antigen Hepatitis B Vaccine Candidate in The Lancet Infectious Diseases.