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

Chengdu Weisk Biopharmaceutical Co., Ltd.

[+1]

NCT05465902

/ Active, not recruitingPhase 2

Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial.
The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine.

Start Date07 Jul 2023

Sponsor / Collaborator

Chengdu Weisk Biopharmaceutical Co., Ltd.

NCT05765604

/ Active, not recruitingPhase 1

A Randomized, Parallel Controlled, Double-blind, Single-center Phase I Clinical Trial of Recombinant COVID-19 Variant Vaccine (Sf9 Cell)(WSK-V102) in People Aged 18 Years or Older

Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.

Start Date14 Mar 2023

Sponsor / Collaborator

Chengdu Weisk Biopharmaceutical 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)

31 Dec 2025·Expert Review of Vaccines

Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged ≥18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial

Article

Author: Tong, Ye-Qing ; Yang, Bei-Fang ; Zeng, Ying ; Ke, Chang-Xian ; Zhang, Xian-Feng ; Zhong, Lin-Feng ; Qian, Xiao’ai ; Jin, Jing ; Li, Zhao-Hong ; Li, Zhao-Xia ; Yang, Zhong-Hua ; Gan, Ze-Hong ; He, Xi-Ran

BACKGROUNDLYB001 is a recombinant protein COVID-19 vaccine displaying a receptor-binding domain (RBD) in a highly immunogenic array on virus-like particles (VLPs). This study assessed the immunogenicity and safety of LYB001 as a booster.RESEARCH DESIGN AND METHODSIn this randomized, active-controlled, double-blinded, phase 3 trial, participants aged ≥ 18 years received a booster with LYB001 or ZF2001 (Recombinant COVID-19 Vaccine). The primary endpoint was to compare the geometric mean titer (GMT) of neutralizing antibodies against Omicron BA.4/5 at 14 days after the booster.RESULTSOverall, 1,200 participants aged ≥ 18 years were enrolled, 599 received LYB001, and 601 received ZF2001. Based on similar baseline level, the 14-day GMT ratio (LYB001/ZF2001) against Omicron BA.4/5 was 1.39 (95% CI: 1.25, 1.56), demonstrating superiority (95% CI lower limit > 1) of LYB001. The spike protein-binding IgG concentrations induced by LYB001 were significantly higher than those induced by ZF2001 on day 14 and day 28 after the booster (p-value <0.0001). LYB001 recipients reported more adverse reactions than ZF2001 recipients (21.4% vs. 15.0%); however, all adverse reactions in the LYB001 group were mild-to-moderate.CONCLUSIONSLYB001 is highly immunogenic and retains a well-characterized safety profile in adults aged ≥ 18 years.CLINICAL TRIAL REGISTRATIONwww.clinicaltrials.gov, identifier is NCT05664932.

01 Mar 2025·Vaccine

A-910823, a squalene-based emulsion adjuvant, enhances robust and broad immune responses of quadrivalent influenza vaccine in ferrets

Article

Author: Saiki, Shou ; Akiyama, Nobuteru ; Nakajima-Yoshida, Hitomi ; Yoshihara, Ken ; Yamamoto-Mizuno, Saki ; Ejima, Aki ; Nojiri, Yasushi ; Omoto, Shinya ; Dohi, Keiji ; Hashimoto, Masayuki ; Yin, Ziwei ; Baba, Kaoru ; Tsujii, Kenichiro

Robust and broad protective immunity is typically elicited by co-administration of an adjuvant with vaccine antigens. A-910823, a squalene-based emulsion adjuvant, has been approved in Japan. It effectively enhances the humoral and cellular immunity of S-268019-b, a recombinant COVID-19 vaccine; however, the adjuvant effects of A-910823 on other vaccines, including influenza vaccine, have not been evaluated. Here, a ferret model was employed to investigate the adjuvant effects of A-910823 when combined with split-inactivated quadrivalent influenza vaccine (QIV). We demonstrate that combination of A-910823 with QIV enhances the neutralizing antibody titer and its breadth against non-vaccine strains. Also, the protective efficacy of A-910823-adjuvanted QIV against virus challenge has been confirmed. Of note, QIV combined with A-910823 caused only minor detectable side effects, whereas a significant increase in fever was observed after two doses of mRNA-LNP in ferrets. This study provides information on the effectiveness and safety of A-910823-adjuvanted QIV and suggests the usefulness of the ferret model for evaluating vaccine-induced reactogenicity.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial

Article

Author: Huang, Tao ; Gao, Lidong ; Yu, Jun ; Zhang, Siyuan ; Dai, Defang ; Zhu, Yinbiao ; Teng, Dewei

The immunogenicity and safety of the concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine (Split Virion) (QIIV) in Chinese adults are unclear. In this open-label, randomized controlled trial, participants aged ≥ 18 years were recruited. Eligible healthy adults were randomly assigned (1:1) to receive QIIV at the same time as the first dose of COVID-19 vaccine (simultaneous-group) or 14 days after the second dose of COVID-19 vaccine (non-simultaneous-group). The primary outcome was to compare the difference in immunogenicity of QIIV (H1N1, H3N2, Yamagata, and Victoria) between the two groups. A total of 299 participants were enrolled, 149 in the simultaneous-group and 150 in the non-simultaneous-group. There were no significant differences in geometric mean titer (GMT) [H1N1: 386.4 (95%CI: 299.2-499.0) vs. 497.4 (95%CI: 377.5-655.3); H3N2: 66.9 (95%CI: 56.1-79.8) vs. 81.4 (95%CI: 67.9-97.5); Yamagata: 95.6 (95%CI: 79.0-115.8) vs. 74.3 (95%CI: 58.6-94.0); and Victoria: 48.5 (95%CI: 37.6-62.6) vs. 65.8 (95%CI: 49.0-88.4)] and seroconversion rate (H1N1: 87.5% vs. 90.1%; H3N2: 58.1% vs. 62.0%; Yamagata: 75.0% vs. 64.5%; and Victoria: 55.1% vs. 62.8%) of QIIV antibodies between the simultaneous and non-simultaneous groups. For the seroprotection rate of QIIV antibodies, a higher seroprotection rate of Yamagata antibody was observed only in the simultaneous-group than in the non-simultaneous-group [86.0% vs. 76.0%, p = .040]. In addition, no significant difference in adverse events was observed between the two groups (14.2% vs. 23.5%, p = .053). In conclusion, no immune interference or safety concerns were found for concomitant administration of COVID-19 vaccine with QIIV in adults aged ≥ 18 years.

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	China	Chengdu Weisk Biopharmaceutical Co., Ltd.	05 Dec 2022

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Kenya	Chengdu Weisk Biopharmaceutical Co., Ltd.	15 Jun 2021
COVID-19	Phase 3	Indonesia	West China Hospital	15 Jun 2021
COVID-19	Phase 3	Philippines	Chengdu Weisk Biopharmaceutical Co., Ltd.	15 Jun 2021
COVID-19	Phase 3	Indonesia	Chengdu Weisk Biopharmaceutical Co., Ltd.	15 Jun 2021
COVID-19	Phase 3	Nepal	Chengdu Weisk Biopharmaceutical Co., Ltd.	15 Jun 2021
COVID-19	Phase 3	Nepal	West China Hospital	15 Jun 2021
COVID-19	Phase 3	Mexico	Chengdu Weisk Biopharmaceutical Co., Ltd.	15 Jun 2021
COVID-19	Phase 3	Philippines	West China Hospital	15 Jun 2021
COVID-19	Phase 3	Kenya	West China Hospital	15 Jun 2021
COVID-19	Phase 3	Mexico	West China Hospital	15 Jun 2021