迅速增加抗HBsAg滴度和更高的血清保护作用”与单价乙型肝炎

StephenW

VBI Vaccines Inc. (VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the company’s abstract titled, “Rapid Increase in Anti-HBsAg Titers and Higher Seroprotection Rates in Adults Immunized with Sci-B-Vac Compared to a Monovalent Hepatitis B Vaccine: Results from PROTECT – a Double-Blind, Randomized, Controlled, Phase-3 Study,” has been selected for a late-breaker poster presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®, on November 11, 2019.

Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study, VBI’s Phase 3 double-blind, randomized study that enrolled 1,607 subjects, will present the poster which highlights the immunogenicity and safety data from PROTECT, detailing three key immunologic takeaways:

    The successfully-met co-primary endpoints of (i) non-inferiority of seroprotection rate in all subjects age 18+ who received Sci-B-Vac compared to Engerix-B, and (ii) superiority of seroprotection rate in subjects age 45+ who received Sci-B-Vac compared to Engerix-B;
    Rapid increase in anti-hepatitis B surface antigen (HBsAg) titers, with higher seroprotection rates in subjects who received Sci-B-Vac compared to Engerix-B at all time points, suggesting a more rapid onset of protection; and
    5-8x higher antibody geometric mean concentration (GMC) in subjects who received Sci-B-Vac compared to Engerix-B, regardless of age, body mass index, diabetic status, and gender.

Presentation Details

- Abstract #: LP13
- Title: Rapid Increase in Anti-HBsAg Titers and Higher Seroprotection Rates in Adults Immunized with Sci-B-Vac Compared to a Monovalent Hepatitis B Vaccine: Results from PROTECT – a Double-Blind, Randomized, Controlled, Phase-3 Study
- Session: Poster Session IV, Monday, November 11, 8 AM – 5:30 PM ET
- Location: Hynes Convention Center, Hall B
- Presentation Time: 12:30 – 1:30 PM ET

About VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only commercially-approved trivalent hepatitis B vaccine, Sci-B-Vac®, which is approved for use in Israel and 10 other countries and is currently in a Phase 3 program in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. Integrating its cytomegalovirus (CMV) expertise with the eVLP platform technology, VBI’s lead eVLP program candidates include a prophylactic CMV vaccine candidate and a glioblastoma (GBM) vaccine immunotherapeutic candidate. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/

StephenW

VBI疫苗公司（VBIV）（“ VBI”）是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，今天宣布该公司的摘要标题为“迅速增加抗HBsAg滴度和更高的血清保护作用”与单价乙型肝炎疫苗相比，接受Sci-B-Vac免疫的成年人的发病率：PROTECT的结果–一项双盲，随机，对照，3期研究，”已被选为美国最新的海报发布者肝病研究协会（AASLD）–肝会议®，于2019年11月11日。

乔安妮·兰利（Joanne Langley）医学博士，达尔豪斯大学CIHR-GSK儿科疫苗学教授，儿科与社区健康与流行病学教授，IWK健康中心传染病科主任，VBI的PROTECT研究主要研究者，VBI的第三阶段该研究招募了1,607名受试者，是一项双盲，随机研究，将重点展示PROTECT的免疫原性和安全性数据，并详细介绍以下三个重要的免疫学要点：

    成功满足以下条件的共同主要终点：（i）与Engerix-B相比，所有接受Sci-B-Vac的18岁以上受试者的血清保护率均低于劣势，以及（ii）45岁以上受试者的血清保护率优越与Engerix-B相比，谁收到了Sci-B-Vac；
    与Engerix-B相比，在所有时间点接受Sci-B-Vac的受试者中抗乙型肝炎表面抗原（HBsAg）滴度的快速升高，以及更高的血清保护率，表明保护起效更快；和
    与Engerix-B相比，接受Sci-B-Vac的受试者的抗体几何平均浓度（GMC）高5-8倍，无论年龄，体重指数，糖尿病状况和性别如何。

演讲内容

-摘要＃：LP13
-标题：与单价乙型肝炎疫苗相比，接受Sci-B-Vac免疫的成年人中抗HBsAg滴度的迅速提高和更高的血清保护率：PROTECT的结果–一项双盲，随机，对照，3期研究
-会议：海报发布会IV，美国东部时间11月11日星期一，上午8点–下午5:30
-地点：Hynes会议中心B厅
-演讲时间：美国东部时间12:30 – 1:30 PM

关于VBI疫苗公司

VBI疫苗公司（Nasdaq：VBIV）是一家商业生物制药公司，致力于开发下一代疫苗，以满足传染病和免疫肿瘤学的未满足需求。 VBI正在使用唯一经商业批准的三价乙型肝炎疫苗Sci-B-Vac®来促进乙型肝炎的预防和治疗，该疫苗已获批准在以色列和其他10个国家中使用，目前正处于第三阶段的计划美国，欧洲和加拿大，以及正在开发用于治疗慢性乙型肝炎的功能性疗法的免疫疗法。VBI的eVLP平台技术允许开发包膜病毒样颗粒（eVLP）疫苗，该疫苗紧密模拟目标病毒以产生有效的免疫反应。 VBI的主要eVLP计划候选人将其巨细胞病毒（CMV）专业知识与eVLP平台技术相结合，包括预防性CMV疫苗候选人和胶质母细胞瘤（GBM）疫苗免疫治疗候选人。 VBI的总部位于马萨诸塞州剑桥市，在加拿大的渥太华设有研究机构，并在以色列的雷霍沃特设有研究和制造机构。

网站主页：http://www.vbivaccines.com/