预约演示
更新于：2025-10-25
Vanutide cridificar
更新于：2025-10-25
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
13
项与 Vanutide cridificar 相关的临床试验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
NCT03104075
Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines
EUCTR2011-001448-31-BE
A Phase 2, open-label, single-center, extension study to evaluate the booster response induced by Vi-CRM197 after priming with either Vi-CRM197 or Typherix administered in adult subjects in H01_04TP study
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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417
项与 Vanutide cridificar 相关的文献（医药）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: Aghamiri, Samira ; Najafabadi, Zahra Salehi ; 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.
2025-09-02PREPARATIVE BIOCHEMISTRY & BIOTECHNOLOGY
Purification of O-antigen for polysaccharide vaccine development against Salmonella paratyphi.
Article
作者: T C, Venkateswarulu ; Kowlakuntla, Eswar Reddy
Enteric fever caused by Salmonella enterica serovar Paratyphi remains a critical public health challenge due to rising incidence and increasing antimicrobial resistance. The development of effective polysaccharide conjugate vaccines targeting Salmonella Paratyphi requires high-purity O-antigen polysaccharide (PS) conjugated to immunogenic carrier proteins. This study optimized a robust and scalable purification-conjugation methodology, specifically tailored for O-antigen from Salmonella Paratyphi. Initial purification utilized ultrafiltration via tangential flow filtration (TFF), followed by sequential cation- and anion-exchange chromatography steps, significantly reducing protein, nucleic acid, and endotoxin contaminants. Optimized conditions included acid precipitation at pH 3.7, dilution prior to hydroxyapatite chromatography (CHT HA Type-I), and the use of a 10 kDa TFF membrane, enhancing antigen recovery and medium molecular weight species retention (>90%). Polysaccharide yield at 80 L scale was 180 mg/L with a recovery efficiency of 38%. Subsequent conjugation of the purified O-antigen with CRM197 was successfully achieved using controlled CDAP-mediated activation and monitored via gel permeation chromatography (GPC), confirming efficient high-molecular-weight conjugate formation. Analytical characterization consistently demonstrated impurity levels well within acceptable vaccine standards (<0.6% protein, <0.2% DNA), and reproducible molecular weight profiles suitable for immunogenic efficacy. Process scalability was validated at laboratory and pilot scales, confirming adaptability for industrial vaccine manufacturing.
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
评价
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临床4期 | 40 | 簾憲鹽願製繭簾鹽範餘(選鹹範願壓襯願膚齋鬱) = 簾獵構鏇構鹽襯膚繭選 夢餘顧夢艱淵構遞廠淵 (簾膚鏇繭遞鑰廠鬱襯蓋, 19.4) 更多 | - | 2021-12-07 | |||
(Pneumovax 23) | 簾憲鹽願製繭簾鹽範餘(選鹹範願壓襯願膚齋鬱) = 遞鬱齋餘蓋糧鑰網積窪 夢餘顧夢艱淵構遞廠淵 (簾膚鏇繭遞鑰廠鬱襯蓋, 18.6) 更多 | ||||||
临床2期 | 32 | QS-21 | 窪糧壓衊積衊壓製廠鹹 = 遞襯艱範繭廠鹽築齋簾 襯鹽構築壓鹽膚餘夢淵 (鹹衊製繭餘憲鹽鹹蓋鏇, 簾鬱構鑰衊製膚艱糧繭 ~ 鹹艱醖蓋膚蓋衊壓鏇齋) 更多 | - | 2016-01-01 |
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