Delving into the Latest Updates on Recombinant protein COVID-19 vaccine (WestVac Biopharma) with Synapse

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).

Start Date01 Jul 2024

Sponsor / Collaborator

Westvac Biopharma Co. Ltd.

[+1]

NCT06381843 / CompletedNot Applicable

A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster in People Aged 18-60 Years

A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.
A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated.

Start Date02 Aug 2022

Sponsor / Collaborator

Westvac Biopharma Co. Ltd.

[+1]

NCT05465785 / CompletedNot Applicable

A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years

This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .

Start Date20 Jul 2022

Sponsor / Collaborator

Westvac Biopharma Co. Ltd.

100 Clinical Results associated with Recombinant protein COVID-19 vaccine (WestVac Biopharma)

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100 Translational Medicine associated with Recombinant protein COVID-19 vaccine (WestVac Biopharma)

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100 Patents (Medical) associated with Recombinant protein COVID-19 vaccine (WestVac Biopharma)

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Literatures (Medical) associated with Recombinant protein COVID-19 vaccine (WestVac Biopharma)

15 Sep 2024·Vaccines

Label-Free Quantitative Proteomics Analysis of COVID-19 Vaccines by Nano LC-HRMS.

Article

Author: Zhao, Hengzhi ; Li, Wendong ; Li, Xiao ; Hu, Mo ; Li, Min ; Ji, Hong ; Liu, Jingjing

A nanoliter liquid chromatography-high resolution mass spectrometry-based method was developed for quantitative proteomics analysis of COVID-19 vaccines. It can be used for simultaneous qualitative and quantitative analysis of target proteins and host cell proteins (HCPs) in vaccine samples. This approach can directly provide protein information at the molecular level. Based on this, the proteomes of 15 batches of COVID-19 inactivated vaccine samples from two companies and 12 batches of COVID-19 recombinant protein vaccine samples from one company were successfully analyzed, which provided a significant amount of valuable information. Samples produced in different batches or by different companies can be systematically contrasted in this way, offering powerful supplements for existing quality standards. This strategy paves the way for profiling proteomics in complex samples and provides a novel perspective on the quality evaluation of bio-macromolecular drugs.

01 Feb 2024·Vaccine

Flu-COVID combo recombinant protein vaccines elicited protective immune responses against both influenza and SARS-CoV-2 viruses infection

Article

Author: Ross, Ted M ; Shi, Hua ; Huang, Ying ; Forgacs, David

SARS-CoV-2 and Influenza viruses are both highly transmissible airborne viruses and causing high morbidity and mortality. Co-infection of these two viruses results in severe disease that have been observed when influenza and SARS-CoV-2 viruses cocirculated in the past three years, and vaccination is still the effective way to prevent these two diseases. However, influenza and COVID-19 vaccines are designed and manufactured in different platforms, all the individuals will need to get two shots in order to prevent those two severe respiratory diseases. Therefore, it is urgent to develop a Flu-COVID combo vaccine to provide an efficient way for receiving immunization against those two diseases. In this study, we developed a flu-COVID combo vaccine that includes both influenza virus haemagglutinin (HA) proteins and SARS-CoV-2 Spike (S) protein which formulated with AddaVax. K18-hACE-2 transgenic mice were intramuscularly vaccinated with either combo vaccine or mono Flu (HA) or COVID (S) recombinant protein vaccine in a prime-boost-boost regimen, and then were challenged with lethal doses of influenza virus or SARS-CoV-2 to evaluate vaccine efficacy. The results showed that Flu-COVID combo vaccine protected mice from both Influenza and SARS-CoV-2 challenge by preventing body weight loss and clinical signs progression. The protective immune responses elicited by Flu-COVID combo vaccine were equivalent to those elicited by mono flu or COVID recombinant protein vaccines. In conclusion, our study highlights the effectiveness of the FLU-COVID combo recombinant protein vaccine in preventing both influenza and COVID-19 infections.

Vaccines

Formulation Development of a COVID-19 Recombinant Spike Protein-Based Vaccine

Article

Author: Mirabel, Clémentine ; Ausar, Salvador Fernando ; Clénet, Didier ; Rahman, Nausheen ; Williams, Trevor ; Xiao, Emily ; Szeto, Jason ; Zhu, Shaolong ; James, Andrew ; Ettorre, Luciano

The purpose of this study was to develop a formulation for a recombinant prefusion spike protein vaccine against SARS-CoV-2. It was found that the spike protein was susceptible to aggregation due to mechanical stress. Therefore, formulation studies were initiated focused on screening pharmaceutical excipients capable of preventing this. The screening of a panel of potential stabilizing conditions found that Tween 20 could inhibit mechanically induced aggregation. A concentration-dependent study indicated that a higher concentration of Tween 20 (0.2% v/v) was required to prevent conformational changes in the trimer. The conformational changes induced by mechanical stress were characterized by size exclusion chromatography (SEC) and hydrogen–deuterium exchange mass spectrometry (HDX-MS), indicating the formation of an extended trimeric conformation that was also unable to bind to antibodies directed to the S2 domain. Long-term stability modeling, using advanced kinetic analysis, indicated that the formulation containing 0.2% (v/v) Tween 20 at a neutral pH was predicted to be stable for at least two years at 2 °C to 8 °C. Additional stabilizer screening conducted by thermal shift assay indicated that sucrose and glycerol were able to significantly increase the spike protein melting temperature (Tm) and improve the overall thermostability of the spike protein in a short-term stability study. Thus, while 0.2% (v/v) Tween 20 was sufficient to prevent aggregation and to maintain spike protein stability under refrigeration, the addition of sucrose further improved vaccine thermostability. Altogether, our study provides a systematic approach to the formulation of protein-based COVID-19 vaccine and highlights the impact of mechanical stress on the conformation of the spike protein and the significance of surfactants and stabilizers in maintaining the structural and functional integrity of the spike protein.

100 Deals associated with Recombinant protein COVID-19 vaccine (WestVac Biopharma)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
COVID-19	CN	Westvac Biopharma Co. Ltd.	05 Dec 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	MX	West China Hospital	15 Jun 2021
COVID-19	Phase 3	ID	Westvac Biopharma Co. Ltd.	15 Jun 2021
COVID-19	Phase 3	KE	Westvac Biopharma Co. Ltd.	15 Jun 2021
COVID-19	Phase 3	ID	West China Hospital	15 Jun 2021
COVID-19	Phase 3	MX	Westvac Biopharma Co. Ltd.	15 Jun 2021
COVID-19	Phase 3	PH	Westvac Biopharma Co. Ltd.	15 Jun 2021
COVID-19	Phase 3	PH	West China Hospital	15 Jun 2021
COVID-19	Phase 3	KE	West China Hospital	15 Jun 2021
COVID-19	Phase 3	NP	West China Hospital	15 Jun 2021
COVID-19	Phase 3	NP	Westvac Biopharma Co. Ltd.	15 Jun 2021