- Vaccination complete in 1,537 subjects in PROTECT Phase 3 study
- No vaccine-related adverse events have been observed to-date
- Top-line data expected mid-2019
VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today 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 U.S., 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.”
About PROTECT – Safety and Immunogenicity Study
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 zero, one, and six. 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® four 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® four 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/