A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

开始日期2022-02-28

申办/合作机构

Vaxart, Inc.

NCT03897309 / Completed临床1期

A Ph 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 With Monovalent or Bivalent Dosing

VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for
4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group
4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.

开始日期2019-03-20

申办/合作机构

Vaxart, Inc.

100 项与 VXA-G2-4-NS 相关的临床结果

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100 项与 VXA-G2-4-NS 相关的转化医学

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100 项与 VXA-G2-4-NS 相关的专利（医药）

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项与 VXA-G2-4-NS 相关的文献（医药）

2023-06-01·Vaccines

Immunogenicity and Blocking Efficacy of Norovirus GII.4 Recombinant P Protein Vaccine.

Article

作者: Cheng, Dongqing ; Xu, Zhangkai ; Jiang, Yi ; Li, Mingfan ; Chen, Chenghao ; Yu, Zhendi ; Shao, Qingyi

Noroviruses (NoVs) are the main cause of acute gastroenteritis in all ages worldwide. The aim of this study was to produce the recombinant P protein of norovirus and to demonstrate its blocking effect. In this study, the engineered strains were induced to express the P protein of NoVs GII.4, which was identified using SDS-PAGE and ELISA as having the capacity to bind to histo-blood group antigens (HBGAs). Rabbits were immunized to obtain neutralizing antibodies. ELISA and ISC-RT-qPCR were used to determine the blocking efficacy of the neutralizing antibody to human norovirus (HuNoV) and murine norovirus (MNV). The recombinant P protein (35 KD) was obtained, and the neutralizing antibody was successfully prepared. The neutralizing antibody could block the binding of the P protein and HuNoV to HBGAs. Neutralizing antibodies can also block MNV invasion into host cells RAW264.7. The recombinant P protein expressed in E. coli can induce antibodies to block HuNoV and MNV. The recombinant P protein of NoVs GII.4 has the value of vaccine development.

2020-08-01·Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology

[Preparation and characterization of monoclonal antibodies against GII.4 norovirus P domain].

Article

作者: Zhang, Ting ; Dai, Yingchun ; Hou, Yuzhen ; Hu, Guifang ; Zhang, Xufu ; Guo, Lunai

Objective To prepare monoclonal antibodies (mAbs) against GII.4 norovirus P domain by multiple antigens in an immunization program. Methods BALB/c mice were immunized with the multiple GII.4 NoV P domain, namely 1996cluster (VA387), 2004cluster, 2006b cluster and 2010 cluster. The spleen cells from the immunized mice were fused with SP2/0 cells and the hybridoma cells were screened by ELISA. The supernatant of the mAbs was collected and purified by the limiting dilution assay. Its subtype was identified, and the specificity and neutralization were analyzed by indirect ELISA and HBGA blocking, respectively. Results We obtained thirteen hybridoma cell lines that stably secreted mAbs against GII.4 NoV P domain. Their titers reached above 10^-4 after purification. The subtypes of the mAbs were identified as IgG1. Indirect ELISA showed that all the mAbs specifically bound to all GII.4 norovirus variants. Five mAbs specifically bound to GII.17, GII.3 and GII.6 variants. Three mAbs specifically bound to GII.2 variants and strongly blocked NoV P particle from binding to the histo-blood group antigen (HBGA) receptors. Conclusion The mAbs against GII.4 norovirus P domain have been obtained by combined antigens immunization program. Multi-antigen immunization can enhance immune response significantly and cross-react with other GII.4 norovirus variants. The findings provide a basis for further development of novel GII.4 norovirus vaccines and for the optimization of the immunization programs of combined multi-antigen vaccine candidates.

项与 VXA-G2-4-NS 相关的新闻（医药）

2024-07-13

·药渡

IIb期失败，武田分拆公司HilleVax股价大跌88%

事件介绍 2021年，武田宣布和Frazier Healthcare Partners合作成立生物制药公司HilleVax，该公司负责武田的诺如病毒候选疫苗HIL-214的开发和商业化。 2022年，HilleVax进行IPO上市，并于同年启动了HIL-214针对婴儿的II期临床试验。而于7月8日，宣布了NEST-IN1研究的破产——由于未达到其主要和次要疗效终点，公司将停止对婴儿进行HIL-214的进一步开发，将继续开发其用于成人的潜力。由此造成HilleVax股价大跌，周一盘前交易中下跌88%，至1.70美元，而周五收盘价为14.06美元。关于HIL-214 HIL-214是一种基于病毒样颗粒（VLP）的候选疫苗，用于预防诺如病毒感染引起的中度至重度急性胃肠炎（AGE）。据估计，全球每年诺如病毒导致约7亿多例AGE病例和20万人死亡，每年直接医疗系统成本超过40亿美元，社会成本超过600亿美元。其中，诺如病毒对幼儿和老年人的负担尤为严重。在HilleVax获得HIL-214之前，已完成了一项随机、安慰剂对照的IIb期研究，共入组4712例成人受试者。研究结果显示，HIL-214耐受性良好，并在预防中度至重度的诺如病毒感染AGE方面展示出具有统计学意义的临床疗效。 2024年1月，HilleVax从康华生物引进重组六价诺如病毒疫苗，以1500万美元首付款，约2.56亿美元的里程碑付款及相应地区个位数百分比销售提成。关于NEST-IN1研究 NEST-IN1是一项随机、双盲、安慰剂对照的IIb期试验，旨在评估HIL-214对初次接种疫苗时约5个月大的婴儿的有效性、安全性和免疫原性，试验地点位于美国和拉丁美洲。主要终点为对GI.1或GII.4诺如病毒基因型引起的中度或重度AGE的疗效。根据新闻稿，在NEST-IN1研究中，共发生了51起主要终点事件——疫苗组为25起（n=1425）；安慰剂组为26起（n=1399）——即有效性仅为5%（95%Cl: -64%,45%）。而除了未达到主要终点之外，在次要终点上未观察到临床益处。 HIL-214在该项研究中表现出的安全性和免疫原性特征，与在NEST-IN1和先前报告研究中对首200名受试者的预定分析中观察到的结果一致。 NEST-IN1是首个在婴儿中进行关于诺如病毒候选疫苗的有效性研究。HilleVax对该项研究结果感到失望，认为“在婴儿环境中的有效性可能受到本次试验中出现的多种新GII.4毒株的影响”。参考资料武田官网 HilleVax Reports Topline Data from NEST-IN1 Phase 2b Clinical Study of HIL-214 in Infants *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容 PROTAC技术后，DUBTAC揭示新型靶向治疗的未来 2025年上市新药谁最具“帝王之象”？诺华通过战略合作和收购扩大放射治疗产品布局点击下方关注，聚焦医药创新一手资讯

临床2期疫苗引进/卖出临床1期IPO

100 项与 VXA-G2-4-NS 相关的药物交易

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