SARS-CoV-2 vaccine(Vicebio)(SARS-CoV-2 vaccine(Vicebio)) - 在研适应症：新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名-

靶点-

作用方式-

作用机制-

治疗领域

感染呼吸系统疾病

在研适应症

新型冠状病毒感染

非在研适应症-

原研机构

Vicebio Ltd.

在研机构

Vicebio Ltd.

非在研机构-

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

100 项与 SARS-CoV-2 vaccine(Vicebio) 相关的临床结果

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100 项与 SARS-CoV-2 vaccine(Vicebio) 相关的转化医学

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100 项与 SARS-CoV-2 vaccine(Vicebio) 相关的专利（医药）

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452

项与 SARS-CoV-2 vaccine(Vicebio) 相关的文献（医药）

2025-12-31·Expert Review of Vaccines

Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants

Article

作者: Liu, Dongfang ; Zhao, Xiuli ; Zhao, Kexin ; Dai, Yuyang ; Hu, Zhongyu ; Zhang, Yun ; Ni, Siyang ; Xie, Zekang ; Shi, Rui ; Cui, Yimin ; Xie, Liangzhi ; Han, Ying ; Liang, Yufei ; Wang, Qian ; Pan, Jing ; Chen, Zhisong ; Zhang, Tianzuo ; Li, Yanhua ; Yang, Xinjie ; Wang, Guiqiang ; Zhang, Chao ; He, Peng ; Li, Jing ; Tian, Qingyun ; Zhao, Xuedan ; Ren, Yanping ; Fu, Yongpan ; Wang, Yanchao ; Zhang, Miaomiao

BACKGROUND:

The development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.

RESEARCH DESIGN AND METHODS:

In this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primary series of two doses and a booster dose of SCTV01C, a bivalent protein SARS-CoV-2 vaccine.

RESULTS:

Geometric mean titers (GMTs) of neutralizing antibodies (nAb) against live Alpha, Beta, Delta, and Omicron showed 85.4-, 100.0-, 32.1-, and 9.8-fold increase from baseline on 28 days, and 49.4-, 55.3-, 5.7-fold increase against live Alpha, Beta, and Omicron on 90 days after primary series. At Day 28 and Day 90 following the booster dose, GMTs of nAb against Beta, BA.2 and BA.5 variants showed 12.1- and 8.8-, 13.8- and 7.1-, 18.7-, and 11.9-fold of increase from baseline, respectively. Reactogenicity was generally mild, with one adverse event of special interest (AESI) and 9 ≥Grade 3 treatment-related adverse events (TRAEs); all recovered within 3 days.

CONCLUSIONS:

SCTV01C, when administered as both a primary series and a booster vaccination, exhibited encouraging sustained immunogenicity against both antigen-matched and antigen-mismatched variants, with no significant safety concerns.

CLINICAL TRIAL REGISTRATION:

www.clinicaltrials.gov identifier is NCT05148091.

2025-07-01·CLINICAL IMMUNOLOGY

Autoantibodies neutralizing type I interferons remain a significant risk factor for critical COVID-19 pneumonia in vaccinated patients

Article

作者: Rocamora-Blanch, Gemma ; Feliubadaló, Lidia ; Antolí, Arnau ; Morandeira, Francisco ; Rofes, Paula ; Bermudez-Carre, Carla ; Gómez-Vázquez, José Luis ; García-Serrano, Lydia ; Viana-Errasti, Julen ; Calatayud, Laura ; Sierra-Fortuny, Angels ; Lázaro, Conxi ; Rigo-Bonnin, Raúl ; Framil, Mario ; Hidalgo-Peña, Lara ; Creus-Bachiller, Edgar ; Del Valle, Jesús ; Solanich, Xavier

BACKGROUND:

Neutralizing autoantibodies against type I interferons were strongly linked to severe COVID-19 in unvaccinated patients; however, this has yet to be evaluated in vaccinated individuals.

OBJECTIVE:

To analyze how these autoantibodies influences disease variability in vaccine breakthrough COVID-19 pneumonia patients.

METHODS:

Clinical and laboratory data; autoantibodies blocking interferon-α2 and -ω; and humoral response to SARS-CoV-2 vaccine were collected from all vaccinated COVID-19 pneumonia patients admitted from April 2021 to December 2022 at Bellvitge University Hospital, Spain.

RESULTS:

458 patients developed COVID-19 pneumonia despite an appropriate antibody response to SARS-CoV-2 vaccination. Autoantibodies neutralizing interferons were significantly more prevalent in patients with critical pneumonia compared to those with milder forms (8.8 % vs. 3.6 %; p = 0.037). Having these autoantibodies was an independent predictor for critical COVID-19 pneumonia (OR 2.88 [95 %CI 1.18-6.98]).

CONCLUSION:

Vaccination considerably reduces the severity of COVID-19; however, patients with type I interferon autoantibodies remain at increased risk of severe disease.

2025-06-01·MEDICINA CLINICA

Effectiveness and immunogenicity of SARS-CoV-2 booster vaccine in immunosuppressed systemic autoimmune disease patients: A prospective study

Article

作者: Teles, Carolina ; Magalhães, Ana ; Crespo, Jorge ; Paiva, Artur ; Barra, Cátia ; Tomé, Patrícia ; Silva, Isabel ; Santos, Lèlita ; Borges, Ana

INTRODUCTION AND OBJECTIVES:

Patients with systemic autoimmune rheumatic disease (SARD) are a vulnerable population for severe COVID-19 and worse response to vaccination, prompting the need of a booster vaccine. Data regarding its response is limited and inconsistent. The aim of this study was to assess the effectiveness and immunogenicity of the third dose of the SARS-CoV-2 vaccine in immunosuppressed SARD patients.

MATERIALS AND METHODS:

We conducted a prospective study in immunosuppressed SARD Portuguese patients, who received a SARS-CoV-2 booster vaccine, from October 2021 to August 2022. We evaluated COVID-19 incidence in the following 6 months, as well as vaccine immunogenicity through anti-Spike IgG titers and T-cell reactivity to the Spike protein.

RESULTS:

We included 131 patients with a mean age of 54.9±12.2 years. Almost 40% (n=52) developed COVID-19 within 6 months after the booster, but 51 (98.1%) were mild infections. Median post-booster antibody levels and antibody variation were 9540.7 (14,724) and 8937.9 (11,561.3)AU/mL, respectively, and 73.3% (n=96) of the patients showed post-booster T-cell reactivity. Antibody variation was significantly lower in the COVID group (p=0.015). Although post-booster antibody levels and T-cell reactivity were statistically significantly lower in the patients under biologic DMARD, there was not a significant increase in COVID-19 incidence.

CONCLUSIONS:

This study shows that a booster vaccine elicits strong immunogenicity and reduces COVID-19 severity, highlighting its importance in immunosuppressed SARD patients. Larger and more homogeneous cohorts are needed to guide periodic booster administration in this susceptible population.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床1期	-	Vicebio Ltd.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ODP516 (ENDO2022)	N/A	亚急性甲状腺炎	1	SARS-CoV-2 Vaccine (Pfizer-BioNTech)	構夢鹹築壓衊獵壓餘遞(襯範憲繭網餘繭醖壓鑰) = A 39-year-old male healthcare worker presented with four weeks history of symptoms: fullness of the anterior neck, odynophagia, enlarged cervical lymph nodes, palpitations, anxiety and weight loss. Onset of symptoms was two days after the second dose of Pfizer-BioNTech vaccine. Initial workup was significant for a TSH of 0.020 uIU/mL, free T4 of 2.42 ng/mL and total T3 225.4 pg/mL. Thyroid scintigraphy was significant for abnormally low uptake, consistent with SAT. Clinical and biochemical improvements were seen after 5 months. 鹽廠網積廠積餘鹽鏇觸 (艱構顧遞網製艱襯夢醖 )	积极	2022-11-01