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更新于：2025-07-19
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更新于：2025-07-19
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NCT07050641
An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours
NCT07040072
The Safety and Efficacy of Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, a Phase Ib Study
CTR20250935
一项评估SCTB14联合培美曲塞和顺铂/卡铂对比安慰剂联合培美曲塞和顺铂/卡铂用于经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗失败的EGFR突变的局部晚期或转移性非鳞非小细胞肺癌患者的II/III期临床研究
100 项与 北京神州细胞生物技术集团股份公司 相关的临床结果
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2025-12-31Expert 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.
2025-07-17Microbiology Spectrum
Immunogenicity of monovalent and multivalent subunit vaccines against SARS-CoV-2 variants in mice with divergent vaccination history.
Article
作者: Zhou, Shaozheng ; Lu, Jianbo ; Lyu, Yuan ; Wang, Rui ; Xie, Liangzhi ; Ma, Juan ; Kong, Desheng ; Li, Xuefeng ; Chen, Meng ; Cui, Yudi ; Sun, Lili
There are challenges in selecting SARS-CoV-2 vaccine compositions, primarily due to divergent infection or vaccination history and immunological biases toward previous strains. In this study, we evaluated humoral immune responses induced by variant-based monovalent vaccines as booster shots in mice previously vaccinated with an ancestral strain-based vaccine with or without Omicron BA.5 exposure. Our data suggest that immunological biases toward earlier variants attenuated the potency of variant-based vaccines as a booster dose against subsequent variants, whereas a second booster dose mitigated this effect. Furthermore, in the context of vaccine-induced immunity, prior exposure to Omicron sublineages (e.g., BA.5) attenuated the effect of immunological biases toward earlier variants on the neutralizing potency against Omicron subvariants. In addition, the interval between vaccine doses should also be considered, as an immunologic plateau might occur after repeated vaccination. Furthermore, the XBB.1 monovalent vaccine and a tetravalent vaccine (SCTV01E-2) composed of pre-Omicron variant (Beta) and Omicron subvariants (BA.1, BQ.1.1, and XBB.1) showed comparable neutralizing potency against several Omicron sublineages (BA.1, BA.5, BQ.1.1, XBB.1, XBB.1.5, XBB.1.16, and EG.5) under divergent vaccination history, implicating that multivalent platforms could be explored as a flexible strategy if future strains diverge significantly from current variants.IMPORTANCEContinuous evolution of SARS-CoV-2 variants has raised the need to optimize immunization regimens and update vaccine compositions to protect against the newly emerging variants in the context of repeated vaccination. The significance of this research is briefly summarized as follows:1) Immunological biases toward earlier variants attenuated the potency of variant-based vaccines as a booster dose against subsequent variants, which can be mitigated by a second booster dose.2) In the context of vaccine-induced immunity, a previous exposure to Omicron sublineages, such as BA.5, attenuated the influence of immunological biases toward earlier variants on the neutralizing potency against Omicron subvariants.3) The interval between vaccine doses should be taken into account since an immunologic plateau might occur after repeated vaccination.4) Multivalent vaccines, with epitope diversity, may theoretically enhance the magnitude and breadth of cross-neutralization responses, thereby providing a buffer for unpredictable future variants.
2025-06-01Contemporary Clinical Trials Communications
Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial
Article
作者: Yan, Lixin ; Diaz, Jorge ; Fonseca, Allex ; Liu, Dongfang ; Xie, Liangzhi
Background/Objective:
The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19.: This study was a randomized, double-blinded, placebo-controlled Phase II trial conducted to evaluate the efficacy of neutralizing monoclonal antibody (SCTA01) in high-risk outpatients diagnosed with COVID-19.
Methods:
The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29.
Results:
109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction (p = 0.20) or symptom score reduction (p = 0.37) between the SCTA01 total and placebo groups. Additionally, the incidence of adverse events was comparable between the SCTA01 group (23.8 %) and the placebo group (24.0 %). Notably, no treatment-related serious adverse events (SAEs) were reported.
Conclusions:
There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated.
CLINICAL TRIAL:
The trial was registered at ClinicalTrial.gov (NCT04709328).
100 项与 北京神州细胞生物技术集团股份公司 相关的药物交易
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100 项与 北京神州细胞生物技术集团股份公司 相关的转化医学
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