预约演示
更新于：2026-02-07
Vanutide cridificar
更新于：2026-02-07
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- |
登录后查看时间轴
结构/序列
Sequence Code 15689
来源: *****
关联
15
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
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)
NCT01227564
A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.
100 项与 Vanutide cridificar 相关的临床结果
登录后查看更多信息
100 项与 Vanutide cridificar 相关的转化医学
登录后查看更多信息
100 项与 Vanutide cridificar 相关的专利（医药）
登录后查看更多信息
357
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.
2026-01-01LANCET INFECTIOUS DISEASES
Safety and immunogenicity of a conjugate vaccine candidate against Salmonella enterica serovars Typhi and Paratyphi A in healthy adults in Europe: a phase 1 randomised controlled trial
Article
作者: Berlanda Scorza, Francesco ; Nigro, Simona ; Rondini, Simona ; De Coster, Ilse ; Conti, Valentino ; Massai, Luisa ; Rossi, Omar ; La Gaetana, Rita ; Serry-Bangura, Alimamy ; Luna Cilio, Giulia ; AbdelGhany, Mohammad ; Fineschi, Chiara ; Withanage, Kanchanamala ; Carducci, Martina ; Van Damme, Pierre ; Tessitore, Pietro ; Nakakana, Usman N ; Micoli, Francesca ; Sarakinou, Eleanna ; Kumar Arora, Ashwani ; Marchetti, Elisa
BACKGROUND:
Enteric fever caused by Salmonella enterica serovars Typhi and Paratyphi A remains a major concern. No vaccines are licensed against Salmonella Paratyphi A. We aimed to assess the safety and immunogenicity of an investigational conjugate vaccine against Salmonella Typhi and Paratyphi A (Vi-CRM197+O:2-CRM197).
METHODS:
In this observer-masked, randomised, controlled, dose-escalation, single-centre, phase 1 trial done during Nov 28, 2022, to April 2, 2024, at the Centre for Evaluation of Vaccination in Belgium, healthy adults (aged 18-50 years) were randomly assigned (2:1 or 2:2:1 across different steps using sealed envelopes following a randomisation schedule generated by an independent statistician) to receive two intramuscular doses (on day 1 and day 169) of one of four Vi-CRM197+O:2-CRM197 formulations (low dose or full dose, with or without aluminium hydroxide) or a control vaccine (Vi capsular polysaccharide vaccine and diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine for first and second dose). The primary outcome was vaccine safety (solicited events during 7 days and unsolicited adverse events during 28 days after vaccination, serious adverse events [SAEs], and adverse events or SAEs leading to study withdrawal or withholding of further study intervention administration from day 1 to day 197, and deviations from normal or baseline laboratory test values 7 days after vaccination). Secondary outcomes included long-term vaccine safety (SAEs and adverse events or SAEs leading to study withdrawal from day 197 to day 337), and immunogenicity, including anti-Vi and anti-O:2 IgG antibody geometric mean concentrations and geometric mean ratios (GMRs) by ELISA, and seroresponses (percentages of participants with anti-Vi IgG concentrations ≥4·3 μg/mL and ≥2·0 μg/mL; ≥4-fold anti-O:2 IgG concentration increase from baseline) at day 1 (as applicable), day 29, day 169, day 176, and day 197. Safety analyses were done on the solicited safety set, unsolicited safety set, and the exposed set. The primary immunogenicity analysis was done on the per-protocol set defined by timepoint. The trial is registered with ClinicalTrials.gov (NCT05613205) and gsk-studyregister.com (205480), and is completed.
FINDINGS:
96 participants were randomly assigned, 12 to each low-dose group, 24 to each full-dose group, and 24 to the control group. The incidence of solicited administration-site events (mostly pain) ranged from six (50% [95% CI 21·1-78·9]) of 12 participants in the low-dose without aluminium hydroxide group to 23 (96% [78·9-99·9]) of 24 in the full-dose with aluminium hydroxide group, versus 22 (92% [73·0-99·0]) of 24 in the control group. Solicited systemic events (mostly fatigue, headache, and myalgia) ranged from eight (67% [34·9-90·1]) of 12 in the low-dose groups to 20 (83% [62·6-95·3]) of 24 in the full-dose with aluminium hydroxide group, versus 21 (88% [67·6-97·3]) of 24 in the control group. The incidence of unsolicited adverse events (mostly nasopharyngitis) ranged from seven (58% [27·7-84·8]) of 12 in the low-dose without aluminium hydroxide group to ten (83% [51·6-97·9]) of 12 in the low-dose with aluminium hydroxide group, versus 14 (58% [36·6-77·9]) of 24 in the control group. Most safety laboratory results were within reference ranges. No SAEs occurred. After dose 1 (ie, at day 29), full-dose without aluminium hydroxide and full-dose with aluminium hydroxide induced the highest anti-Vi IgG responses (GMR 53·01 [95% CI 31·94-87·99] and 31·55 [18·74-53·11], respectively) versus control (4·50 [2·93-6·90]). Full-dose without aluminium hydroxide and low-dose without aluminium hydroxide induced the highest anti-O:2 IgG responses after dose 1 (GMR 162·61 [91·17-290·04] and 114·19 [44·83-290·86], respectively), versus control (1·27 [1·02-1·60]). 89-100% and 82-100% of participants (lowest percentages for low-dose with aluminium hydroxide) had anti-Vi IgG ≥4·3 μg/mL at day 29 (in initially seronegative participants) and ≥4-fold anti-O:2 IgG increase from baseline, respectively, versus 13 (54% [95% CI 32·8-74·4]) and one (4% [0·1-21·1]) of 24 participants in the control group, respectively. The second dose did not boost the responses.
INTERPRETATION:
Vi-CRM197+O:2-CRM197 formulations did not raise safety concerns and showed immunogenicity with a single dose, supporting further clinical assessment of the full-dose without aluminium hydroxide in target populations (infants and older age groups) in endemic regions.
FUNDING:
Wellcome Trust.
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.
112
项与 Vanutide cridificar 相关的新闻（医药）2026-02-05
·微信
临床2期抗体药物偶联物临床3期临床结果临床1期
2026-02-04
2026-02-03
免疫疗法疫苗临床3期抗体药物偶联物细胞疗法
100 项与 Vanutide cridificar 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 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 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 32 | QS-21 | 鏇壓積願選憲膚醖鏇築 = 襯顧繭壓築窪鬱觸顧獵 範夢顧膚夢鑰夢遞壓憲 (鹽憲襯夢簾築積簾鏇夢, 積鹹窪齋築衊鏇鑰願鹹 ~ 獵觸醖壓蓋鹽齋顧鏇膚) 更多 | - | 2016-01-01 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用