VBI疫苗宣布公布VBI预防性3抗原乙肝疫苗的4期研究结果

StephenW

VBI Vaccines Announces Publication of Results from a Phase 4 Study of VBI’s Prophylactic 3-Antigen Hepatitis B Vaccine in Vaccine

Published: Jan 15, 2021
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that results from a Phase 4 study of VBI’s prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier. The study was designed to evaluate the immunogenicity of VBI’s 3-antigen HBV vaccine in support of the qualification of that batch as a new reference standard for vaccine release to the Israeli market, where VBI’s vaccine is available as Sci-B-Vac®.

“In this Phase 4 study, our 3-antigen HBV vaccine once again demonstrated robust immunogenicity with no additional safety signals observed,” said Dr. Francisco Diaz-Mitoma, VBI’s Chief Medical Officer. “The rapid onset of protection seen in this study may be particularly relevant to younger adults who need protection quickly, including healthcare workers and travelers. We believe our vaccine could be a meaningful intervention in the fight to eliminate hepatitis B and we look forward to working with the U.S. Food and Drug Administration and the European Medicines Agency in 2021 as part of the licensure process to expand access to this vaccine outside of Israel.”

Prior to market release in Israel, batches of VBI’s vaccine are tested against a reference vaccine batch that has been assessed in a clinical trial. According to the European Pharmacopeia, the reference batch should elicit, after the full course of vaccination, a seroprotection rate (SPR) of at least 95% in young and healthy adult participants. In this open-label, single-arm Phase 4 study in 91 healthy adults age 20-40 years, this objective was achieved two months after the second dose – the SPR at month 3 was 98.8% [95% CI: 93.7%, 99.7%]. SPR is defined as the percent of participants who achieve antibody titers (anti-HBs titers) above the protective threshold of 10 mIU/mL.

Additional results from this Phase 4 study include:

    By month 7, after receiving three doses, all enrolled participants (100%) were seroprotected
    The majority of participants were high responders, defined as achievement of anti-HBs titers ≥ 100 mIU/mL – high-responder SPR was 81.4% and 97.6% at month 3 (after 2 doses) and month 7 (after 3 doses), respectively
    The geometric mean concentration (GMC) of anti-HBs titers were also substantially above the protective threshold at 413.6 mIU/mL and 6799.9 mIU/mL at month 3 and month 7, respectively
    Anti-HBs titers were maintained above 2000 mIU/mL at month 12, suggesting a potent and sustained response
    Consistent with other clinical data, VBI’s 3-antigen HBV vaccine was well-tolerated with no safety signals observed

Participants in this study were immunized with 10 µg of VBI’s HBV vaccine at months 0, 1, and 6.

The manuscript is available at: https://www.sciencedirect.com/sc ... /S0264410X20316303.

About Hepatitis B

StephenW

VBI疫苗宣布公布VBI预防性3抗原乙肝疫苗的4期研究结果

发行时间：2021年1月15日
马萨诸塞州坎布里奇-（BUSINESS WIRE）-（美国商业资讯）-商业级生物制药公司VBI Vaccines Inc.（纳斯达克股票代码：VBIV）（VBI）今天宣布，该药物是开发阶段传染性疾病和免疫肿瘤疫苗的结果Elsevier的杂志Vaccine刊登了4篇关于VBI预防性3-抗原乙型肝炎病毒（HBV）疫苗的研究。这项研究旨在评估VBI的3抗原HBV疫苗的免疫原性，以支持该批次作为向以色列市场发布疫苗的新参考标准的资格，在那里VBI的疫苗以Sci-B-Vac®的形式提供。

VBI首席医学官Francisco Diaz-Mitoma博士说：“在这项4期研究中，我们的3-抗原HBV疫苗再次显示出强大的免疫原性，没有观察到其他安全信号。” “这项研究中看到的保护的快速发作可能与需要快速保护的年轻人（包括医护人员和旅行者）特别相关。我们认为，我们的疫苗可能是消除乙型肝炎的有效干预措施，我们希望在2021年与美国食品药品监督管理局和欧洲药品管理局合作，以此作为许可过程的一部分，以扩大在该国以外地区使用该疫苗的机会以色列。”

在以色列投放市场之前，要对VBI疫苗的批次与参考疫苗进行测试，该参考疫苗已在临床试验中进行了评估。根据欧洲药典，在整个疫苗接种过程中，参考批次应在年轻和健康的成年人受试者中引起至少95％的血清保护率（SPR）。在这项公开的单臂4期研究中，该研究针对91位20-40岁的健康成年人，在第二次给药后两个月就实现了这一目标–第3个月的SPR为98.8％[95％CI：93.7％，99.7 ％]。 SPR定义为达到高于保护性阈值10 mIU / mL的抗体滴度（抗HBs滴度）的参与者百分比。

第四阶段研究的其他结果包括：

    到第7个月，接受三剂治疗后，所有入组参与者（100％）都进行了血清保护
    大部分参与者为高反应者，定义为抗HBs滴度≥100 mIU / mL –高反应者SPR在第3个月（2剂后）和第7个月（3剂后）分别为81.4％和97.6％。
    抗HBs滴度的几何平均浓度（GMC）也在第3个月和第7个月分别显着高于保护性阈值分别为413.6 mIU / mL和6799.9 mIU / mL。
    第12个月的抗HBs滴度保持在2000 mIU / mL以上，表明有力且持续的反应
    与其他临床数据一致，VBI的3-抗原HBV疫苗耐受良好，未观察到安全信号

在第0、1和6个月，用10 µg VBI的HBV疫苗免疫了这项研究的参与者。

该手稿可在以下网址获得：https：//www.sciencedirect.com/science/article/pii/S0264410X20316303。

liuzai

不知道这个可不可以做治疗性用