Delving into the Latest Updates on Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Genetically engineered subunit vaccine

Synonyms

Zifivax, 智克威得

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

Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.

Active Organization

Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

UZ (01 Mar 2021),

COVID-19

RegulationEmergency Use Authorization (ID), Conditional marketing approval (CN)

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Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study.
Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of enhanced immunization with the new coronal prototype vaccine.
Test groups:Study group；Control group；Observation group ①；Observation group ②

Start Date29 Aug 2022

Sponsor / Collaborator

Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.

[+1]

TCTR20220318001 / Not yet recruitingPhase 2/3IIT

Vaccine effectiveness and safety of ZF2001 protein subunit vaccine as the heterologous booster dose COVID-19 vaccine, immunobridging study

Start Date01 Apr 2022

Sponsor / Collaborator-

NCT05128643 / Unknown statusPhase 3

Clinical Study on the Immunogenicity and Safety of the Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) 0-1-6 Month and 0-1-4 Month Immunization Programs in People Aged 18 and Above

Popular topic：Clinical study on the immune program of recombinant Novel Coronavirus (COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate the immunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and over. Secondary purpose: To evaluate the safety of the investigational vaccine in people aged 18 and above.
Overall design: In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety.
Study population:The study involved people 18 years of age and older. Test groups：A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).

Start Date17 Sep 2021

Sponsor / Collaborator

Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

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100 Translational Medicine associated with Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

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100 Patents (Medical) associated with Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

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61

Literatures (Medical) associated with Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Response to comment on ‘Clinical characteristics and risk factors for ZF2001 fully vaccinated inpatients with COVID-19: A retrospective cohort study’

Article

Author: Jin, Liping ; Sun, Yuming ; Zeng, Furong ; Le, Jiayuan

31 Dec 2024·Human Vaccines & Immunotherapeutics

Clinical characteristics and risk factors for ZF2001 fully vaccinated inpatients with COVID-19: A retrospective cohort study

Article

Author: Jin, Liping ; Sun, Yuming ; Zeng, Furong ; Han, Chaofei ; Dian, Yating ; Deng, Guangtong

The ZF2001 vaccine has demonstrated high efficacy in preventing coronavirus disease 2019 (COVID-19). However, the clinical characteristics of breakthrough infections in vaccinated individuals and the risk factors for adverse outcomes in COVID-19 patients remain unclear. We conducted a retrospective single-center cohort study at Xiangya Hospital of Central South University, including 210 fully vaccinated COVID-19 inpatients from December 5, 2022, to January 31, 2023. Data on clinical characteristics, laboratory findings, disease severity, treatment, and prognosis were collected and analyzed. Our findings revealed that COVID-19 inpatients still experienced common symptoms at the onset of illness, but most laboratory findings were within the normal range, except for white blood cell count (WBC), lymphocyte count, and lactate dehydrogenase (LDH) levels. Following standard treatment, 95.7% of patients were discharged from the hospital. We identified seven variables significantly associated with a higher risk of adverse outcomes, including age over 65, elevated WBC count, reduced lymphocyte count, higher levels of blood urea nitrogen (BUN), LDH, troponin, D-dimer, and procalcitonin. This study supports the substantial clinical benefits of the ZF2001 vaccine for COVID-19 patients. Additionally, age over 65, elevated WBC count, reduced lymphocyte count, and higher blood levels of BUN, LDH, D-dimer, and procalcitonin may be used as predictive factors for disease progression in fully vaccinated COVID-19 inpatients.

01 Jun 2024·Molecular & Cellular Proteomics

Proteomic and Cellular Characterization of Omicron Breakthrough Infections and a Third Homologous or Heterologous Boosting Vaccination in a Longitudinal Cohort

Article

Author: Zhang, Wenhong ; Zhang, Yi ; Song, Jieyu ; Sun, Rui ; Fan, Mingxiang ; Jiang, Ning ; Guo, Jingxin ; Zhang, Haocheng ; Zhang, Qiran ; Qiu, Chao ; Yuan, Guanmin ; Wang, Hongyu ; Guo, Tiannan ; Zhao, Yuanhan ; Ai, Jingwen ; Fu, Zhangfan ; Lin, Ke

The understanding of dynamic plasma proteome features in hybrid immunity and breakthrough infection is limited. A deeper understanding of the immune differences between heterologous and homologous immunization could assist in the future establishment of vaccination strategies. In this study, 40 participants who received a third dose of either a homologous BBIBP-CorV or a heterologous ZF2001 protein subunit vaccine following two doses of inactivated coronavirus disease 2019 vaccines and 12 patients with BA2.2 breakthrough infections were enrolled. Serum samples were collected at days 0, 28, and 180 following the boosting vaccination and breakthrough and then analyzed using neutralizing antibody tests and mass spectrometer-based proteomics. Mass cytometry of peripheral blood mononuclear cell samples was also performed in this cohort. The chemokine signaling pathway and humoral response markers (IgG2 and IgG3) associated with infection were found to be upregulated in breakthrough infections compared to vaccination-induced immunity. Elevated expression of IGKV, IGHV, IL-17 signaling, and the phagocytosis pathway, along with lower expression of FGL2, were correlated with higher antibody levels in the boosting vaccination groups. The MAPK signaling pathway and Fc gamma R-mediated phagocytosis were more enriched in the heterologous immunization groups than in the homologous immunization groups. Breakthrough infections can trigger more intensive inflammatory chemokine responses than vaccination. T-cell and innate immune activation have been shown to be closely related to enhanced antibody levels after vaccination and therefore might be potential targets for vaccine adjuvant design.

100 Deals associated with Recombinant SARS-CoV-2 vaccine (CHO Cell)(Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
COVID-19	UZ	Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.	01 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Discovery	EC	Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.	16 Dec 2020
COVID-19	Discovery	PK	Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.	16 Dec 2020