VBIV: Completes Enrollment Ph3 Sci-B-Vac Study
Apr 19, 2018 13:20:17 GMT
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Post by icemandios on Apr 19, 2018 13:20:17 GMT
VBI Vaccines Announces Completion of Enrollment in PROTECT Phase 3 Clinical Study for Sci-B-Vac® Hepatitis B Vaccine
More than 1,600 subjects enrolled in PROTECT study
Topline data expected mid-2019
CAMBRIDGE, Mass., April 19, 2018 (GLOBE NEWSWIRE) -- VBI Vaccines Inc. (NASDAQ:VBIV) (“VBI”) today announced the completion of enrollment with the last patient receiving the first dose in the ongoing PROTECT Phase 3 study of Sci-B-Vac®, the company’s third-generation hepatitis B vaccine. More than 1,600 adults have now been enrolled in the PROTECT study at 27 sites across the U.S., Europe, and Canada.
The PROTECT study is one of two ongoing global studies that form the Phase 3 program for Sci-B-Vac®. It 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 the U.S., Europe, and Canada.
“The completion of enrollment in the PROTECT study is a significant milestone in this pivotal Phase III program,” said Jeff Baxter, President and CEO of VBI.
“Data from this head-to-head immunogenicity study will inform the positioning and differentiation of Sci-B-Vac®. We look forward to reporting the topline data and remain dedicated to advancing Sci-B-Vac® through phase 3 development as quickly as possible.”
Topline data from the PROTECT study are expected mid-year 2019.
About PROTECT – Safety and Immunogenicity Study
PROTECT is a double-blind, two-arm, randomized, controlled study. More than 1,600 adult subjects, 18 years of age and older, have been randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac® 10μg or a three-dose course of the control vaccine, Engerix-B® 20μg. Under the planned dosing schedule, subjects will be vaccinated at months zero, one, and six. Enrollment has been stratified by age group.
The co-primary objectives of the 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®.
About Sci-B-Vac®
Sci-B-Vac® is a licensed third-generation hepatitis B vaccine that has demonstrated 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: www.vbivaccines.com/sci-b-vac/
More than 1,600 subjects enrolled in PROTECT study
Topline data expected mid-2019
CAMBRIDGE, Mass., April 19, 2018 (GLOBE NEWSWIRE) -- VBI Vaccines Inc. (NASDAQ:VBIV) (“VBI”) today announced the completion of enrollment with the last patient receiving the first dose in the ongoing PROTECT Phase 3 study of Sci-B-Vac®, the company’s third-generation hepatitis B vaccine. More than 1,600 adults have now been enrolled in the PROTECT study at 27 sites across the U.S., Europe, and Canada.
The PROTECT study is one of two ongoing global studies that form the Phase 3 program for Sci-B-Vac®. It 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 the U.S., Europe, and Canada.
“The completion of enrollment in the PROTECT study is a significant milestone in this pivotal Phase III program,” said Jeff Baxter, President and CEO of VBI.
“Data from this head-to-head immunogenicity study will inform the positioning and differentiation of Sci-B-Vac®. We look forward to reporting the topline data and remain dedicated to advancing Sci-B-Vac® through phase 3 development as quickly as possible.”
Topline data from the PROTECT study are expected mid-year 2019.
About PROTECT – Safety and Immunogenicity Study
PROTECT is a double-blind, two-arm, randomized, controlled study. More than 1,600 adult subjects, 18 years of age and older, have been randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac® 10μg or a three-dose course of the control vaccine, Engerix-B® 20μg. Under the planned dosing schedule, subjects will be vaccinated at months zero, one, and six. Enrollment has been stratified by age group.
The co-primary objectives of the 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®.
About Sci-B-Vac®
Sci-B-Vac® is a licensed third-generation hepatitis B vaccine that has demonstrated 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: www.vbivaccines.com/sci-b-vac/