预约演示
更新于：2025-12-27
Vanutide cridificar
更新于：2025-12-27
概要
基本信息
原研机构 |
在研机构- |
权益机构- |
最高研发阶段终止临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 15689
来源: *****
关联
15
项与 Vanutide cridificar 相关的临床试验ChiCTR2000031515
A Randomized, Blinded, Positive-Controlled Phase I Clinical Trial to Preliminary Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT) in Healthy People Aged 6 Weeks and Above
CTRI/2018/11/016419
A multicentre single blind randomised controlled Phase-II/III study to evaluate immunogenicity and safety of single intramuscular dose of Biological Eâ??s Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine in healthy infants, children and adults in comparison with a licensed comparator. - None
JPRN-jRCT2080221374
A Phase IIa, Multicenter, Treatment Assigned, Open-Label, Long-Term Extension Study To Determine Safety, Tolerability And Immunogenicity Of ACC-001 With QS-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease(B2571001)
100 项与 Vanutide cridificar 相关的临床结果
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100 项与 Vanutide cridificar 相关的转化医学
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100 项与 Vanutide cridificar 相关的专利（医药）
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365
项与 Vanutide cridificar 相关的文献（医药）2026-01-01INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES
Efficient bioprocess for high-density fermentation and rapid purification of soluble tag-free CRM197 protein expressed in Escherichia coli
Article
作者: Singh, Shubham ; Mishra, Ravi P N ; Mehta, Jaideep
Cross-reacting material 197, or CRM197, is a genetically detoxified variant of diphtheria toxin that is an integral part of several approved polysaccharide-conjugate vaccines against encapsulated pathogenic bacteria. CRM197 is a high-value protein needed as a carrier protein in enormous quantities for the manufacturing of conjugate vaccines, which are critical components of global immunisation programs, with billions of doses required each year. However, the scarcity of high-yielding clones, along with the inherent difficulties of soluble protein production and purification, necessitates the intercession of an efficient bioprocess to meet this gap. In the current investigation, we designed a codon-optimized gene construct (named pET30a_crm197) and generated a clone in the E. coli-SHuffle T7 strain that expressed a very high quantity of tag-free soluble recombinant CRM197 protein. With the use of this E. coli clone, a robust inventive fermentation process was designed and carried out, producing a remarkable yield of soluble recombinant CRM197 (up to about 1500 mg/L). Controlled fermentation conditions and rational tweaking to the culture media's carbon, nitrogen, and trace elements were part of the process of optimizing protein expression. Subsequently, an interpreted, rapid, and high-efficiency protein purification process was developed, which uses tangential-flow filtration (TFF) followed by single-step ion-exchange chromatography to produce bioactive and appropriately folded CRM197 protein of high purity. The physicochemical and functional properties of purified CRM197 were determined using various analytical techniques, which confirmed the protein's identity, purity, stability, bioactivity, and secondary structure. This overall work offers vaccine developers a cost-effective, scalable, and integrated bioprocess for high-yield soluble production and purification of rCRM197 carrier protein.
2025-10-01EBioMedicine
Safety and immunogenicity of two Tau-targeting active immunotherapies, ACI-35.030 and JACI-35.054, in participants with early Alzheimer's disease: a phase 1b/2a, multicentre, double-blind, randomised, placebo-controlled study
Article
作者: Börjesson-Hanson, Anne ; Jonsson, Michael ; Hliva, Valérie ; Kosco-Vilbois, Marie ; Pfeifer, Andrea ; Gerasymchuk, Viktoriia ; Sol, Olivier ; Hallikainen, Merja ; Fournier, Nicolas ; Rinne, Juha ; Dautzenberg, Paul ; Streffer, Johannes ; Steukers, Lennert ; Kurl, Sudhir ; Vijverberg, Everard G B ; Scheltens, Philip ; Theunis, Clara ; Gollwitzer, Eva ; Mummery, Catherine ; Fiorini, Emma ; Gray, Julian ; Ritchie, Craig ; Wagg, Jonathan ; Kezic, Iva ; Mermoud, Julien ; Vukicevic, Marija ; Triana-Baltzer, Gallen ; Hickman, David T ; Pennington, Catherine ; Lê, Bénédicte
BACKGROUND:
Active immunotherapies targeting C-terminal phosphorylated Tau species have the potential to efficiently reduce Tau spreading. ACI-35.030, a SupraAntigen®-based liposome, and JACI-35.054, a CRM197 carrier-protein conjugate, share the same immunogenic pTau sequence and were assessed to determine the best formulation for preferential activation of B cells specific to pathological Tau forms.
METHODS:
Individuals with early AD were enrolled in this randomised, double-blind, placebo-controlled study (NCT04445831). Participants were randomly assigned to 2 cohorts (ACI-35.030 at 300, 900, 1800 μg or placebo; and JACI-35.054 at 15, 60 μg or placebo) and received 4 intramuscular injections over 48 weeks, followed up to week 74. Participants receiving at least one dose of study drug were included in the intention-to-treat analysis. The primary objectives were safety, tolerability and immunogenicity.
FINDINGS:
Among the 57 randomised participants, 41 were assigned to the ACI-35.030 cohort and 16 to the JACI-35.054 cohort. The most frequent adverse events observed consistently in both active groups were injection site reactions (16.7%-100%) and headaches (16.7%-50%). No relevant MRI findings and no adverse events leading to study discontinuation were reported. ACI-35.030 required only one injection to induce anti-pTau IgG titres in all participants and consistently boosted levels with subsequent immunisations. JACI-35.054 raised a strong but more heterogenous anti-pTau IgG response and required multiple administrations to reach consistent titres in all participants. ACI-35.030 induced a robust polyclonal antibody response binding enriched PHF from AD brain tissue while concurrently sparing the response to non-phosphorylated Tau. A post-hoc statistical analysis revealed statistically significant differences between some randomised actively treated groups and the pooled placebo group on plasma pTau217 and brain-derived Tau changes from baseline.
INTERPRETATION:
ACI-35.030 and JACI-35.054 were well tolerated. ACI-35.030 induced a more rapid and sustained antibody response selective to p-Tau species with evidence of altering AD-related plasma biomarkers and was selected for testing in the ongoing Phase 2b trial.
FUNDING:
AC Immune SA and Johnson & Johnson Innovative Medicine.
2025-09-18CURRENT PHARMACEUTICAL DESIGN
Preparation and Evaluation of Sodium Alginate Nanoparticles Containing Recombinant Diphtheria Toxoid (CRM197) and their Immunogenicity in Mice
Article
作者: Najafabadi, Zahra Salehi ; Aghamiri, Samira ; Goudarzi, Hamid Reza ; Saffarian, Parvaneh ; Noofeli, Mojtaba
Introduction::
Recombinant protein vaccines against infectious diseases, based on immunogenic antigen identification and employing polymeric nanoparticles as a delivery system, can provoke immune responses comparable to or better than traditional vaccines. The production of a safe and immunogenic vaccine against diphtheria was achieved by preparing sodium alginate nanoparticles containing recombinant diphtheria toxoid (CRM197).
Methods::
Alginate nanoparticles loaded with CRM197 were prepared using the ionic-gelation method and thoroughly characterized. Safety and immunogenicity studies were conducted in an animal model for comparison with commercial vaccines. Antibody responses were evaluated using both qualitative and quantitative measurements, as determined by the toxin neutralization test (TNT) and indirect ELISA, respectively. IgG subclasses in the sera of immunized mice and possible pathological lesions in vital tissues of all immunized mouse groups were investigated.
Results::
Nanoparticles with or without CRM197 were synthesized by the ionic gelation method. LE and LC measurements showed ?80% and ?20%, respectively, indicating stable and persistent release without a bursting pattern. In vivo studies showed safety and enhanced immunogenicity in mice immunized with the CRM197- loaded sodium alginate nanoparticles, with higher levels of total anti-CRM197 IgG and subclasses than those induced by conventional vaccines.
Discussion::
Reducing antigen usage in vaccine production while increasing immunogenicity and safety compared with traditional vaccines are the goals of new vaccine development, which were achieved in the current study.
Conclusion::
Engineered alginate nanoparticles loaded with recombinant diphtheria antigen (CRM197) demonstrated in vitro controlled and slow release, as well as safety and immunogenicity profiles against diphtheria in vivo. Nanoparticles containing CRM197 antigens equivalent to adult and children doses showed high levels of IgG1 and IgG2a, confirming the combined responses of the humoral and cellular immune systems.
95
项与 Vanutide cridificar 相关的新闻（医药）2025-12-22
2025-12-19
疫苗引进/卖出申请上市临床1期
2025-12-18
疫苗免疫疗法
100 项与 Vanutide cridificar 相关的药物交易
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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 |
|---|---|---|---|---|
| 阿尔茨海默症 | 临床2期 | 法国 | 2007-05-01 | |
| 阿尔茨海默症 | 临床2期 | 法国 | 2007-05-01 | |
| 阿尔茨海默症 | 临床2期 | 德国 | 2007-05-01 | |
| 阿尔茨海默症 | 临床2期 | 德国 | 2007-05-01 | |
| 阿尔茨海默症 | 临床2期 | 西班牙 | 2007-05-01 | |
| 阿尔茨海默症 | 临床2期 | 西班牙 | 2007-05-01 |
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临床结果
临床结果
适应症
分期
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临床2期 | 32 | QS-21 | 鬱願鏇觸衊繭廠願鹽廠 = 構簾鏇範願憲鏇範觸願 鹹獵廠醖憲顧蓋網獵鹽 (遞構積鑰網鬱繭廠襯夢, 積壓艱製憲鏇壓鑰廠網 ~ 觸繭網襯獵構壓繭構蓋) 更多 | - | 2016-01-01 |
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