Last update 21 Nov 2024

Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Prophylactic vaccine, Fusion protein

Synonyms

Recombinant SARSCoV2 Fusion Protein Vaccine, Recombinant coronavirus fusion protein vaccine Livzon Mabpharm/Institute of Biophysics Chinese Academy of Sciences, V01 Livzon Mabpharm/Institute of Biophysics Chinese Academy of Sciences

+ [3]

Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein inhibitors(Coronavirus spike glycoprotein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19

Inactive Indication-

Originator Organization

Livzon MABPharm Inc.Institute of Biophysics of Chinese Academy of Sciences

Active Organization

Livzon Pharmaceutical Group, Inc.

Livzon MABPharm Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (02 Sep 2022),

COVID-19

RegulationEmergency Use Authorization (CN)

Clinical Trials associated with Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

NCT05585567 / Active, not recruitingEarly Phase 1

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.

Start Date16 Sep 2022

Sponsor / Collaborator

Livzon Pharmaceutical Group, Inc.

NCT05238649 / Unknown statusPhase 2

A Randomized, Double Blind, Positive Control 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

Start Date10 Nov 2021

Sponsor / Collaborator

Livzon Pharmaceutical Group, Inc.

NCT05096832 / CompletedPhase 3

A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity 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

A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity 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

Start Date03 Nov 2021

Sponsor / Collaborator

Livzon Pharmaceutical Group, Inc.

100 Clinical Results associated with Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

100 Translational Medicine associated with Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

100 Patents (Medical) associated with Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

Literatures (Medical) associated with Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

24 May 2023·NPJ vaccines

Developmental and reproductive toxicity of a recombinant protein subunit COVID-19 vaccine (ZF2001) in rats.

Article

Author: She, Guangbiao ; Dai, Lianpan ; Gao, George F ; Chen, Guoyu ; Zhang, Lili ; Shao, Jinjin ; Song, Yisheng ; Liu, Jing ; Tian, Ruiyu ; Zhang, Chengda ; Huang, Enqi ; Lv, Wanqiang ; Wang, Jiahong ; Zhang, Lijiang

ZF2001, a protein subunit vaccine against coronavirus disease 2019 (COVID-19), contains recombinant tandem repeat of dimeric receptor-binding domain (RBD) protein of the SARS-CoV-2 spike protein with an aluminium-based adjuvant. During the development of this vaccine, two nonclinical studies were conducted to evaluate female fertility, embryo-fetal development, and postnatal developmental toxicity in Sprague‒Dawley rats according to the ICH S5 (R3) guideline. In Study 1 (embryo-fetal developmental toxicity, EFD), 144 virgin female rats were randomly assigned into four groups and received three doses of vaccine (25 μg or 50 μg RBD protein/dose, containing the aluminium-based adjuvant), the aluminium-based adjuvant or a sodium chloride injection administered intramuscularly on days 21 and 7 prior to mating and on gestation day (GD) 6. In Study 2 (pre- and postnatal developmental toxicity, PPND), ZF2001 at a dose of 25 μg RBD protein/dose or sodium chloride injection was administered intramuscularly to female rats (n = 28 per group) 7 days prior to mating and on GD 6, GD 20 and postnatal day (PND) 10. There were no obvious adverse effects in dams, except for local injection site reactions related to the aluminium-based adjuvant (yellow nodular deposits in the interstitial muscle fibres). There were also no effects of ZF2001 on the mating performance, fertility or reproductive performance of parental females, embryo-fetal development, postnatal survival, growth, physical development, reflex ontogeny, behavioural and neurofunctional development, or reproductive performance of the offspring. The strong immune responses associated with binding and neutralising antibodies were both confirmed in dams and fetuses or offspring in these two studies. These results would support clinical trials or the use of ZF2001 in maternal immunisation campaigns, including those involving women with childbearing potential, regardless of pregnancy status.

100 Deals associated with Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
COVID-19	CN	Livzon MABPharm Inc.	02 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	RU	Livzon Pharmaceutical Group, Inc.	25 Aug 2021
COVID-19	Phase 3	ID	Livzon Pharmaceutical Group, Inc.	25 Aug 2021
COVID-19	Phase 3	PH	Livzon Pharmaceutical Group, Inc.	25 Aug 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05096832 (Pubmed) Manual	Phase 3	COVID-19	10,218	V-01	(ozxwtcvotp) = ehyumkvkcr cteuakbjie (nswgvwydji ) View more	Positive	10 Jun 2022
				Placebo	(ozxwtcvotp) = guqbfitwos cteuakbjie (nswgvwydji )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Recombinant Covid-19 Fusion Protein Vaccine(Livzon Mabpharm/Institute of Biophysics, Chinese Academy of Sciences)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation