106 0 Kommentare 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 - Seite 2

Results from this Phase 3 study include:

The seroprotection rate (SPR) – defined as the percent of participants who achieved antibody (anti-HBs) titers above the protective threshold of 10 mIU/mL – in participants ≥ 18 years was 91.4% for VBI’s vaccine compared to 76.5% for Engerix-B at Day 196
The SPR in adults ≥ 45 years was 89.4% for VBI’s vaccine vs. 73.1% for Engerix-B at Day 196, exceeding the pre-set margins for statistical superiority and clinical superiority
In adults age 18-44 years, the SPR after two doses (Day 168) of VBI’s vaccine was comparable to three doses of Engerix-B (Day 196) – 87.2% vs. 91.1%, respectively
In all participants, the decrease of SPR from Day 196 (peak titers) to Day 336 (end of study) decreased less for VBI’s vaccine (91.4% to 89.0%) compared to Engerix-B (76.5% to 68.8%)
In all participants, VBI’s vaccine elicited 6x higher Geometric Mean Concentration (GMC) of anti-HBs titers (1148.2 mIU/mL vs. 192.6 mIU/mL)
Regardless of age, BMI, or diabetic status, participants who received VBI’s vaccine had higher SPRs and 5-8x higher antibody GMC compared to Engerix-B
The safety and tolerability seen in this study were consistent with safety data from previous clinical studies – no safety signals observed in either vaccine arm, and no new safety risks identified

Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, “We are honored to have the results of the PROTECT study published in The Lancet Infectious Diseases, enabling us to share additional information around our 3-antigen vaccine candidate with the scientific and medical communities. We believe this vaccine candidate has the potential to be a meaningful intervention for adults in the fight against HBV and we look forward to continued discussions with regulatory agencies in North America and Europe as we work to provide broad access to this vaccine candidate.”

The PROTECT study reported top-line results in June 2019, and was a randomized, controlled, double-blind trial conducted at 28 research centers in the U.S., Finland, Belgium, and Canada. The study enrolled 1,607 adults age ≥ 18. Study participants were randomized 1:1 to receive a 3-dose regimen of either 10 µg of VBI’s 3-antigen vaccine, or 20 µg of Engerix-B, given at Days 0, 28, and 168.

The full manuscript can be found online here:
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)3078 ...