VBI Vaccines Completes Vaccination in PROTECT Phase 3 Clinical Study
VBI Vaccines Inc. recently announced the last subject has received the last vaccination in the PROTECT Phase 3 study of Sci-B-Vac, the company’s third-generation prophylactic hepatitis B vaccine. Additionally, the independent Data and Safety Monitoring Board has reviewed all safety data from the global Phase 3 program available to-date and has not identified any safety signals or vaccine-related adverse events. Top-line data from this study are expected mid-2019.
The PROTECT study is one of two ongoing global pivotal studies that form the Phase 3 program for Sci-B-Vac. With 27 sites across the US, Europe, and Canada, PROTECT is designed to evaluate the safety and immunogenicity of Sci-B-Vac compared with the control vaccine, Engerix-B, in support of future regulatory filings in all three regions.
“Completion of vaccination in the PROTECT study is a significant milestone in the development of Sci-B-Vac,” said Jeff Baxter, VBI’s President and CEO. “Patients have been enrolled and vaccinated with a very low drop-out rate of only 4.5%, which is very encouraging and points to the safety and tolerability of Sci-B-Vac. As we have discussed with regulatory agencies, data from the PROTECT study will be used as part of NDA and MAA submissions for Sci-B-Vac. We remain confident that Sci-B-Vac has the ability to advance prevention of Hepatitis B and we look forward to providing top-line data in mid-2019.”
PROTECT is a double-blind, two-arm, randomized, controlled study, that enrolled subjects 18 years of age and older. Subjects were randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac 10 μg or a three-dose course of the control vaccine, Engerix-B 20 μg. Under the planned dosing schedule, subjects were vaccinated at months 0, 1, and 6. Enrollment was stratified by age group.
The co-primary objectives of the PROTECT study are:
-To demonstrate non-inferiority of the seroprotection rate induced by Sci-B-Vac vs. Engerix-B 4 weeks after the third vaccination in adults age 18 and older.
-To demonstrate superiority of the seroprotection rate induced by Sci-B-Vac vs. Engerix-B 4 weeks after the third vaccination in adults older than 45 years of age.
The study also includes multiple secondary objectives to evaluate the speed to seroprotection, including assessment after two doses of Sci-B-Vac vs. three doses of Engerix-B, and the overall safety and tolerability of Sci-B-Vac vs. Engerix-B.
Sci-B-Vac is a licensed third-generation hepatitis B vaccine that demonstrates safety and efficacy in over 500,000 patients. Sci-B-Vac is currently approved for use in Israel and in 14 other countries. In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac may prove more immunogenic in subjects that currently do not respond optimally to second-generation vaccines. To learn more about Sci-B-Vac, visit https://www.vbivaccines.com/sci-b-vac/.
VBI Vaccines Inc. is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 10 other countries. VBI’s eVLP Platform technology enables the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma (GBM). VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.
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