VBI疫苗完成PROTECT第3期Sci-B-Vac®乙型肝炎疫苗临床研究的疫苗

StephenW

VBI Vaccines Completes Vaccination in PROTECT Phase 3 Clinical Study for Sci-B-Vac® Hepatitis B Vaccine

    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

CAMBRIDGE, Mass., Oct. 16, 2018 (GLOBE NEWSWIRE) -- 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®.

About Sci-B-Vac®

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/

StephenW

VBI疫苗完成PROTECT第3期Sci-B-Vac®乙型肝炎疫苗临床研究的疫苗接种

    在PROTECT第3阶段研究中，1,537名受试者接种疫苗
    迄今未观察到与疫苗相关的不良事件
    预计2019年中期的顶线数据

马萨诸塞州剑桥市，2018年10月16日（GLOBE NEWSWIRE） - VBI疫苗公司（纳斯达克股票代码：VBIV）（“VBI”），一家开发下一代传染病和免疫肿瘤疫苗的商业阶段生物制药公司宣布最后一个受试者已经接受了该公司第三代预防性乙型肝炎疫苗Sci-B-Vac®的PROTECT第3阶段研究的最后一次疫苗接种。此外，独立的数据和安全监测委员会已经审查了迄今为止可用的全球第3阶段计划的所有安全性数据，并未发现任何安全信号或与疫苗相关的不良事件。该研究的最佳数据预计在2019年中期。

PROTECT研究是两项正在进行的全球关键研究之一，它们构成了Sci-B-Vac®的第3阶段计划。 PROTECT在美国，欧洲和加拿大拥有27个站点，旨在评估Sci-B-Vac®与对照疫苗Engerix-B®相比的安全性和免疫原性，以支持所有三个地区的未来监管备案。

“在PROTECT研究中完成疫苗接种是Sci-B-Vac®发展的一个重要里程碑，”VBI总裁兼首席执行官Jeff Baxter说。 “患者已经注册并接种疫苗的辍学率仅为4.5％，这非常令人鼓舞，并指出了Sci-B-Vac®的安全性和耐受性。正如我们与监管机构讨论的那样，PROTECT研究的数据将被用作Sci-B-Vac的NDA和MAA提交的一部分。我们仍然相信Sci-B-Vac能够预防乙型肝炎，我们期待在2019年中期提供最佳数据。“

关于PROTECT - 安全性和免疫原性研究

PROTECT是一项双盲，双臂，随机，对照研究，纳入18岁及以上的受试者。受试者以1：1的比例随机化，以接受3剂量的Sci-B-Vac®10μg疗程或3剂疗程的对照疫苗Engerix-B®20μg。根据计划的给药方案，受试者在零，一和六月接种疫苗。入学按年龄组分层。

PROTECT研究的共同主要目标是：

    为了证明Sci-B-Vac®对Engerix-B®诱导的血清保护率的非劣效性，在第三次接种后四周，在18岁及以上的成年人中。
    为了证明Sci-B-Vac®与Engerix-B®诱导的血清保护率优于第四次疫苗接种后四周，年龄超过45岁的成年人。

该研究还包括评估血清保护速度的多个次要目标，包括两剂Sci-B-Vac®与三剂Engerix-B®后的评估，以及Sci-B-Vac®对比的总体安全性和耐受性.Engerix-B®。

关于Sci-B-Vac®

Sci-B-Vac®是一种获得许可的第三代乙型肝炎疫苗，可为超过500,000名患者提供安全性和有效性。 Sci-B-Vac目前已获准在以色列和其他14个国家使用。与仅含有一种表面抗原（S抗原）的第二代乙型肝炎疫苗相比，Sci-B-Vac含有S抗原和前S1和前S2表面抗原。 Sci-B-Vac的组成可能在目前对第二代疫苗没有最佳反应的受试者中证明更具免疫原性。

要了解有关Sci-B-Vac®的更多信息，请访问：https：//www.vbivaccines.com/sci-b-vac/