Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc)(Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc))

概要

基本信息

药物类型

预防性疫苗、融合蛋白

别名

V-01-B5

靶点

SARS-CoV-2 antigen

作用机制

新冠病毒抗原抑制剂

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

新型冠状病毒感染

原研机构

丽珠医药集团股份有限公司

在研机构-

非在研机构

丽珠医药集团股份有限公司

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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关联

4

项与 Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc) 相关的临床试验

NCT05585567 / Active, not recruiting早期临床1期

A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine

It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.

开始日期2022-09-16

申办/合作机构

丽珠医药集团股份有限公司

NCT05125874 / Unknown statusN/A

A Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines

开始日期2021-09-30

申办/合作机构

丽珠医药集团股份有限公司

NCT05050474 / Completed临床1期

A Clinical Study to Evaluate the Immunogenicity and Safety of the Third Dose Booster Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants

This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01.
The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.

开始日期2021-08-07

申办/合作机构

丽珠医药集团股份有限公司

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100 项与 Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc) 相关的临床结果

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100 项与 Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc) 相关的转化医学

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100 项与 Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc) 相关的专利（医药）

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2

项与 Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc) 相关的文献（医药）

2024-07-25·The Journal of infectious diseases

Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial

Article

作者: Patel, Nita ; Deshmukh, Sachin ; Cho, Iksung ; Plested, Joyce S. ; Marcheschi, Alex ; Cloney-Clark, Shane ; Kalkeri, Raj ; Bennett, Chijioke ; Mallory, Raburn M. ; Pardey, Toni McCallum ; Bloch, Mark ; Glenn, Gregory M. ; Cumming, Oscar ; Woo, Wayne ; Smith, Gale ; Griffin, Paul ; Swan, Jennifer ; Mohan, Rahul ; Zhu, Mingzhu ; Neville, A. Munro ; Rivers, E. Joy ; Walker, Robert ; Arya, Mark ; Buchanan, Agi ; Cheung, King

Abstract:

Background:

Mutations present in emerging SARS-CoV-2 variants permit evasion of neutralization with prototype vaccines. A novel Omicron BA.1 subvariant–specific vaccine (NVX-CoV2515) was tested alone or as a bivalent preparation with the prototype vaccine (NVX-CoV2373) to assess antibody responses to SARS-CoV-2.

Methods:

Participants aged 18 to 64 years immunized with 3 doses of prototype mRNA vaccines were randomized 1:1:1 to receive a single dose of NVX-CoV2515, NVX-CoV2373, or the bivalent mixture in a phase 3 study investigating heterologous boosting with SARS-CoV-2 recombinant spike protein vaccines. Immunogenicity was measured 14 and 28 days after vaccination for the SARS-CoV-2 Omicron BA.1 sublineage and ancestral strain. Safety profiles of vaccines were assessed.

Results:

Of participants who received trial vaccine (N = 829), those administered NVX-CoV2515 (n = 286) demonstrated a superior neutralizing antibody response to BA.1 vs NVX-CoV2373 (n = 274) at day 14 (geometric mean titer ratio, 1.6; 95% CI, 1.33–2.03). Seroresponse rates were 73.4% (91/124; 95% CI, 64.7–80.9) for NVX-CoV2515 vs 50.9% (59/116; 95% CI, 41.4–60.3) for NVX-CoV2373. All formulations were similarly well tolerated.

Conclusions:

NVX-CoV2515 elicited a superior neutralizing antibody response against the Omicron BA.1 subvariant as compared with NVX-CoV2373 when administered as a fourth dose. Safety data were consistent with the established safety profile of NVX-CoV2373.

Clinical Trials Registration:

ClinicalTrials.gov (NCT05372588).

2020-07-01·Vaccine3区 · 医学

Recombinant SARS-CoV-2 spike S1-Fc fusion protein induced high levels of neutralizing responses in nonhuman primates

3区 · 医学

Article

作者: Ren, Wenlin ; Sun, Yufei ; Fang, Feng ; Gong, Sitao ; Hu, Yalin ; Li, Maohua ; Chen, Jinggong ; Chen, Jianxin ; Li, Min ; Jin, Xia ; Gao, Wen ; Su, Junchi ; Zhao, Gan ; He, Ailiang ; Zhao, Rongqing ; Xia, Chenxi ; Sun, Sean ; Sun, Hunter ; Gao, George F ; Wang, Qi ; Sun, Le ; Cheng, Xin ; Chen, Yuxin ; Gao, Guang

The COVID-19 outbreak has become a global pandemic responsible for over 2,000,000 confirmed cases and over 126,000 deaths worldwide. In this study, we examined the immunogenicity of CHO-expressed recombinant SARS-CoV-2 S1-Fc fusion protein in mice, rabbits, and monkeys as a potential candidate for a COVID-19 vaccine. We demonstrate that the S1-Fc fusion protein is extremely immunogenic, as evidenced by strong antibody titers observed by day 7. Strong virus neutralizing activity was observed on day 14 in rabbits immunized with the S1-Fc fusion protein using a pseudovirus neutralization assay. Most importantly, in <20 days and three injections of the S1-Fc fusion protein, two monkeys developed higher virus neutralizing titers than a recovered COVID-19 patient in a live SARS-CoV-2 infection assay. Our data strongly suggests that the CHO-expressed SARS-CoV-2 S1-Fc recombinant protein could be a strong candidate for vaccine development against COVID-19.

100 项与 Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine(Livzon Pharmaceutical Group Inc) 相关的药物交易

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