MVC-COV1901(MVC-COV1901) - 药物靶点：SARS-CoV-2 S protein_在研适应症：新型冠状病毒感染_专利_临床

A Phase III, Parallel Group, Prospective, Randomized, Double-blind, Active-controlled, Two-arm, Multi-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of MVC-COV1901 Compared to AZD1222 in Adult of 18 Years and Above

The purpose of this study is to assess the immunogenicity and safety of MVC- COV1901 vaccine compared to AZD1222 in heathy adults.

开始日期2022-07-30

申办/合作机构

高端疫苗生物制剂股份有限公司

NCT05426343 / Completed临床3期

A Phase III, Parallel-Group, Prospective, Randomized, Double-blind, Active-controlled, Two- Arm Study to Evaluate the Immunogenicity, Safety, and Tolerability of the MVC-COV1901 Compared to AZD1222 in Adult of 18 Years and Above.

The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants, in particular elderly, so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of antigen-specific immunoglobulin as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.

开始日期2022-07-09

申办/合作机构

高端疫苗生物制剂股份有限公司

NCT05216601 / Completed临床1期

A Phase I, Prospective, Randomized, Open-labeled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Booster Dose With MVC-COV1901 or MVC-COV1901(Beta) SARS-CoV-2 Vaccine in Adults

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include:
The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up).
The treatment duration will be 1 day. -The visit frequency will be 6 on-site visits (1 screening visit, 1 treatment visit, and 4 follow- up visits) and 1 phone visit.

开始日期2022-05-06

申办/合作机构

高端疫苗生物制剂股份有限公司

100 项与 MVC-COV1901 相关的临床结果

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100 项与 MVC-COV1901 相关的转化医学

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100 项与 MVC-COV1901 相关的专利（医药）

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31

项与 MVC-COV1901 相关的文献（医药）

2024-11-01·Circulation Journal

Clinical and Histopathological Characteristics of Patients With Myocarditis After mRNA COVID-19 Vaccination

Article

作者: Amiya, Eisuke ; Kato, Seiya ; Nagai, Toshiyuki ; Okumura, Takahiro ; Goto, Hidemasa ; Sakata, Yasushi ; Yoshizawa, Saeko ; Hatakeyama, Kinta ; Ishibashi-Ueda, Hatsue ; Suzuki, Tadaki ; Ohta-Ogo, Keiko ; Oikawa, Masayoshi ; Hiroe, Michiaki ; Nakamura, Kazufumi ; Maruyama, Kazuaki ; Dohi, Kaoru ; Moriwaki, Keishi ; Nakamori, Shiro ; Imanaka-Yoshida, Kyoko ; Onoue, Kenji ; Omori, Taku ; Fujino, Takeo ; Anzai, Toshihisa

BACKGROUNDThe effects of myocarditis after mRNA COVID-19 vaccination (mCV) on myocardial tissue, and the association between cardiomyocyte injury and clinical presentation, are not fully understood.METHODS AND RESULTSWe retrospectively registered patients clinically diagnosed with myocarditis after the first or second mCV who underwent endomyocardial biopsy or autopsy from 42 participating centers in Japan. We investigated the histological features and their association with clinical presentation based on cardiomyocyte injury. Forty patients who underwent endomyocardial biopsy were included in the study. Of these, 19 (47.5%) showed mild lymphocytic infiltration and interstitial edema without cardiomyocyte injury. The remaining 21 (52.5%) patients showed cardiomyocyte injury accompanied by infiltrating inflammatory cells: 11 with lymphocytic infiltration, 7 with eosinophilic infiltration, and 3 with myocarditis with both lymphocyte and eosinophil infiltration. Compared with patients without cardiomyocyte injury, those with cardiomyocyte injury were clinically characterized by older age, a balanced sex distribution, less frequent chest pain, and a lower left ventricular ejection fraction. Fifteen of 21 (71.4%) patients with cardiomyocyte injury developed fulminant myocarditis, with 13 (86.7%) requiring mechanical circulatory support; in contrast, none of those without cardiomyocyte injury developed fulminant myocarditis (P<0.001).CONCLUSIONSOur histological examination of patients with myocarditis after mCV revealed varying degrees of cardiomyocyte injury, ranging from pronounced to absent, along with various types of myocarditis. Cardiomyocyte injury was strongly associated with the severity of myocarditis.

2024-03-01·Journal of Medical Virology

Temporal changes in biomarkers of neutrophil extracellular traps and NET‐promoting autoantibodies following adenovirus‐vectored, mRNA, and recombinant protein COVID‐19 vaccination

Article

作者: Kuo, Yu-Min ; Hsieh, Song-Chou ; Tzeng, Shiang-Jong ; Lai, Zhi-Yun ; Kang, Chun-Min ; Chen, Shey-Ying ; Hsu, Chih-Chieh ; Jung, Chiau-Jing ; Chia, Jean-San ; Hsueh, Po-Ren ; Huang, Ting-Yu

AbstractNeutrophil extracellular traps (NETs) play a role in innate pathogen defense and also trigger B‐cell response by providing antigens. NETs have been linked to vaccine‐induced thrombotic thrombocytopenia. We postulated a potential link between NET biomarkers, NET‐promoting autoantibodies, and adverse events (AEs) after COVID‐19 vaccine boosters. Healthy donors (HDs) who received ChAdOx1‐S (A), mRNA‐1273 (M), or recombinant protein (MVC–COV1901) vaccines at the National Taiwan University Hospital between 2021 and 2022 were recruited. We measured serial NET‐associated biomarkers, citrullinated‐histone3 (citH3), and myeloperoxidase (MPO)‐DNA. Serum citH3 and MPO‐DNA were significantly or numerically higher in HDs who reported AEs (n = 100, booster Day 0/Day 30, p = 0.01/p = 0.03 and p = 0.30/p = 0.35, respectively). We also observed a positive correlation between rash occurrence in online diaries and elevated citH3. A linear mixed model also revealed significantly higher citH3 levels in mRNA‐1273/ChAdOx1‐S recipients than MVC‐COV1901 recipients. Significant positive correlations were observed between the ratios of anti‐heparin platelet factor 4 and citH3 levels on Booster Day 0 and naïve and between the ratios of anti‐NET IgM and citH3 on Booster Day 30/Day 0 in the AA‐M and MM‐M group, respectively. The increased levels of citH3/MPO‐DNA accompanied by NET‐promoting autoantibodies suggest a potential connection between mRNA‐1273/ChAdOx1‐S vaccines and cardiovascular complications. These findings provide insights for risk assessments of future vaccines.

2023-11-01·Journal of the Formosan Medical Association

Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study

Article

作者: Chen, Charles ; Sun, Hsin-Yun ; Huang, Szu-Ting ; Hsieh, Szu-Min ; Lien, Chia-En ; Liu, Wang-Da ; Huang, Yu-Shan ; Pan, Sung-Ching

BACKGROUND/PURPOSEMVC-COV1901 is a protein vaccine based on the same SARS-CoV-2 strain used in mRNA vaccine mRNA-1273. Data are lacking on immunogenicity and safety of MVC-COV1901 as heterologous boost for people already received one dose of mRNA-1273.METHODSThis is a randomized, double-blind trial that recruited adults aged 20-70 years who previously received a single dose of mRNA-1273 vaccine and were randomly assigned in a 1:1 ratio to receive a second dose with the homologous vaccine or protein-based MVC-COV1901 8-12 weeks after the first dose. The primary outcome was neutralizing antibody titers in terms of the geometric mean titer (GMT) 14 days after the second dose. Safety was assessed in all participants who received a dose of the study vaccine. The study is registered with ClinicalTrials.gov (NCT05079633).RESULTSFrom September 30 to November 5, 2021, 144 participants were enrolled and randomly assigned to the MVC-COV1901 boost group (n = 72) or the mRNA-1273 boost group (n = 72). The neutralizing antibodies on Day 15 and the anti-SARS-CoV-2 IgG titers on Day 15 and 29 of homologous mRNA-1273 were significantly higher than those of heterologous mRNA-1273/MVC-COV1901. Cellular immune responses were comparable in both groups. However, adverse events were much more frequent after the mRNA-1273 boost than after the MVC-COV1901 boost.CONCLUSIONOur results show that heterologous boost with MVC-COV1901 yielded an inferior immunogenicity but significantly fewer adverse events, compared with homologous boost with mRNA-1273. In people experienced severe adverse events after prime dose of mRNA-1273, as well as in periods when the supply of mRNA-1273 is limited, MVC-COV1901 could serve as an acceptable alternative heterologous boost.

100 项与 MVC-COV1901 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15854

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适应症	国家/地区	公司	日期
新型冠状病毒感染	中国台湾	高端疫苗生物制剂股份有限公司	2021-07-17

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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3期	巴拉圭	高端疫苗生物制剂股份有限公司	2021-10-08
严重急性呼吸综合征	临床2期	越南	高端疫苗生物制剂股份有限公司	2020-12-30
严重急性呼吸综合征	临床2期	中国台湾	高端疫苗生物制剂股份有限公司	2020-12-30