This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

开始日期2020-10-30

申办/合作机构

Jiangsu Province Centers for Disease Control and Prevention

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100 项与 Recombinant SARS-CoV-2 Vaccine (CHO Cell) (Liaoning Maokangyuan Biotech/Zhongyi Anke Biotechology) 相关的临床结果

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100 项与 Recombinant SARS-CoV-2 Vaccine (CHO Cell) (Liaoning Maokangyuan Biotech/Zhongyi Anke Biotechology) 相关的转化医学

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100 项与 Recombinant SARS-CoV-2 Vaccine (CHO Cell) (Liaoning Maokangyuan Biotech/Zhongyi Anke Biotechology) 相关的专利（医药）

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项与 Recombinant SARS-CoV-2 Vaccine (CHO Cell) (Liaoning Maokangyuan Biotech/Zhongyi Anke Biotechology) 相关的文献（医药）

2023-12-15·Human vaccines & immunotherapeutics

Safety and immunogenicity of a heterologous booster with an RBD virus-like particle vaccine following two- or three-dose inactivated COVID-19 vaccine

Article

作者: Yang, Zhonghua ; Yong, Xiaolan ; Liu, Yan ; Zeng, Ying ; Nie, Jing ; Kang, Wei ; Liu, Jun ; Chen, Yiyong ; Wang, Tao ; Cui, Xuelian ; Wang, Yilin

LYB001 is an innovative recombinant SARS-CoV-2 vaccine that displays a repetitive array of the spike glycoprotein's receptor-binding domain (RBD) on a virus-like particle (VLP) vector to boost the immune system, produced using Covalink plug-and-display protein binding technology. LYB001's safety and immunogenicity were assessed in 119 participants receiving a booster with (1) 30 μg LYB001 (I-I-30 L) or CoronaVac (I-I-C), (2) 60 μg LYB001 (I-I-60 L) or CoronaVac in a ratio of 2:1 after two-dose primary series of inactivated COVID-19 vaccine, and (3) 30 μg LYB001 (I-I-I-30 L) after three-dose inactivated COVID-19 vaccine. A well-tolerated reactogenicity profile was observed for LYB001 as a heterologous booster, with adverse reactions being predominantly mild in severity and transient. LYB001 elicited a substantial increase in terms of the neutralizing antibody response against prototype SARS-CoV-2 28 days after booster, with GMT (95%CI) of 1237.8 (747.2, 2050.6), 554.3 (374.6, 820.2), 181.9 (107.6, 307.6), and 1200.2 (831.5, 1732.3) in the I-I-30 L, I-I-60 L, I-I-C, and I-I-I-30 L groups, respectively. LYB001 also elicited a cross-neutralizing antibody response against the BA.4/5 strain, dominant during the study period, with GMT of 201.1 (102.7, 393.7), 63.0 (35.1, 113.1), 29.2 (16.9, 50.3), and 115.3 (63.9, 208.1) in the I-I-30 L, I-I-60 L, I-I-C, and I-I-I-30 L groups, respectively, at 28 days after booster. Additionally, RBD-specific IFN-γ, IL-2, IL-4 secreting T cells dramatically increased at 14 days after a single LYB001 booster. Our data confirmed the favorable safety and immunogenicity profile of LYB001 and supported the continued clinical development of this promising candidate that utilizes the VLP platform to provide protection against COVID-19.

2023-04-01·International journal of biological macromolecules

Bidirectional and persistent immunomodulation of Astragalus polysaccharide as an adjuvant of influenza and recombinant SARS-CoV-2 vaccine

Article

作者: Yue, Na ; Li, Xinyu ; Fei, Wenting ; Zhao, Zhongpeng ; He, Wei ; Wang, Linyuan ; Zhao, Danping ; Chen, Xiuhong ; Zhang, Jianjun ; Zhu, Yingli ; Tan, Lingyun

Respiratory viral infections, such as coronavirus disease of 2019 (COVID-19) and influenza, cause significant morbidity and mortality and have become a worldwide public health concern with tremendous economic and societal burdens. Vaccination is a major strategy for preventing infections. However, some new vaccines have an unmet need for impairing responses in certain individuals, especially COVID-19 vaccines, despite ongoing vaccine and adjuvant research. Here, we evaluated the effectiveness of Astragalus polysaccharide (APS), a bioactive polysaccharide extracted from the traditional Chinese herb Astragalus membranaceus as an immune adjuvant to regulate the efficacy of influenza split vaccine (ISV) and recombinant severe acute respiratory syndrome (SARS)-Cov-2 vaccine in mice. Our data indicated that APS as an adjuvant can facilitate the induction of high levels of hemagglutination inhibition (HAI) titer and specific antibody immunoglobulin G (IgG) and confer protection against the lethal challenge of influenza A viruses, including increased survival and amelioration of weight loss in mice immunized with the ISV. RNA sequencing (RNA-seq) analysis revealed that the NF-κB and Fc gamma R-mediated phagocytosis signaling pathways are essential for the immune response of mice immunized with the recombinant SARS-Cov-2 vaccine (RSV). Another important finding was that bidirectional immunomodulation of APS on cellular and humoral immunity was observed, and APS-adjuvant-induced antibodies persisted at a high level for at least 20 weeks. These findings suggest that APS is a potent adjuvant for influenza and COVID-19 vaccines, and has the advantages of bidirectional immunoregulation and persistent immunity.

2022-12-15·The Journal of clinical investigation

Stabilized recombinant SARS-CoV-2 spike antigen enhances vaccine immunogenicity and protective capacity

Article

作者: Dulovic, Alex ; Rohde, Cornelius ; Tscherne, Alina ; Mayer, Leonie ; Beythien, Georg ; Volz, Asisa ; Becker, Stephan ; Ciurkiewicz, Malgorzata ; Fathi, Anahita ; Addo, Marylyn M ; Kupke, Alexandra ; Fendel, Rolf ; Dahlke, Christine ; Esen, Meral ; Klug, Martha ; Armando, Federico ; Baumgärtner, Wolfgang ; Schwarz, Jan H ; Limpinsel, Leonard ; Jany, Sylvia ; Meyer Zu Natrup, Christian ; Schünemann, Lisa-Marie ; Halwe, Sandro ; Freudenstein, Astrid ; Schneiderhan-Marra, Nicole ; Shin, Dai-Lun ; Clever, Sabrina ; Kalodimou, Georgia ; Sutter, Gerd ; Kremsner, Peter ; Weskamm, Marie L ; Brosinski, Katrin ; Tuchel, Tamara

The SARS-CoV-2 spike (S) glycoprotein is synthesized as a large precursor protein and must be activated by proteolytic cleavage into S1 and S2. A recombinant modified vaccinia virus Ankara (MVA) expressing native, full-length S protein (MVA-SARS-2-S) is currently under investigation as a candidate vaccine in phase I clinical studies. Initial results from immunogenicity monitoring revealed induction of S-specific antibodies binding to S2, but low-level antibody responses to the S1 domain. Follow-up investigations of native S antigen synthesis in MVA-SARS-2-S-infected cells revealed limited levels of S1 protein on the cell surface. In contrast, we found superior S1 cell surface presentation upon infection with a recombinant MVA expressing a stabilized version of SARS-CoV-2 S protein with an inactivated S1/S2 cleavage site and K986P and V987P mutations (MVA-SARS-2-ST). When comparing immunogenicity of MVA vector vaccines, mice vaccinated with MVA-SARS-2-ST mounted substantial levels of broadly reactive anti-S antibodies that effectively neutralized different SARS-CoV-2 variants. Importantly, intramuscular MVA-SARS-2-ST immunization of hamsters and mice resulted in potent immune responses upon challenge infection and protected from disease and severe lung pathology. Our results suggest that MVA-SARS-2-ST represents an improved clinical candidate vaccine and that the presence of plasma membrane-bound S1 is highly beneficial to induce protective antibody levels.

100 项与 Recombinant SARS-CoV-2 Vaccine (CHO Cell) (Liaoning Maokangyuan Biotech/Zhongyi Anke Biotechology) 相关的药物交易

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