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Adjuvance Technologies公布其下一代皂苷佐剂的首批临床结果

2021-08-25 国际文传 网络

结果显示TQL-1055在所有剂量水平下耐受良好

Adjuvance Technologies Inc.是一家私有临床阶段生物制药公司,致力于开发面向感染性疾病和免疫肿瘤学的皂苷佐剂和疫苗。该公司宣布,添加其TQL-1055佐剂的百日咳疫苗接种安全且耐受良好。这是该公司佐剂和疫苗产品阵容中候选药物的首次临床试验。

Adjuvance首席执行官Tyler Martin M.D.表示:“皂苷佐剂的功用一直受制于剂量限制耐受性和生产工艺等难题。我们的半合成分子技术旨在克服上述局限。令人鼓舞的中期结果显示,TQL-1055具有广阔的发展前景,包括不影响良好耐受性前提下的更宽泛的剂量使用范围。”

该试验的中期数据显示,TQL-1055在所有剂量水平上总体耐受良好,总体安全性接近市售百日咳疫苗。受试者诉称的主动事件包括轻度至中度注射部位反应和轻度或中度全身症状,频次接近市售疫苗。未见严重不良事件报告。

进行中的随机、双盲、活性对照、剂量递增1期研究正在评估添加TQL-1055佐剂的百日咳无细胞疫苗(Pertussis Acellular Vaccine Adjuvanted, PAVA)的安全性和免疫原性。该研究已全数募集72例18-50岁健康成人,正在评估25至800微克六种递增剂量水平的TQL-1055与市售百日咳疫苗联合给药的结果。该研究的主要终点是安全性和耐受性。更多相关数据将在IDWeek 2021上公布。

关于百日咳:百日咳是一种人传人的呼吸道疾病。百日咳疫苗任何年龄均可接种,许多国家建议所有儿童和成人接种百日咳疫苗。从1970年代到2010年代,美国每年通报的百日咳病例数增加了10倍,表明需要更有效的疫苗和接种。

关于TQL-1055TQL-1055是一种合理设计的半合成皂苷佐剂QS-21类似物,旨在提高疫苗耐受性并提供与QS-21相同的强免疫应答。Adjuvance在保留QS-21多种理想特性的同时,解决了QS-21存在的若干问题。TQL-1055是一种半合成分子,其高效合成工艺采用来自皂树(Quillaja saponaria)树叶和树枝的原料,原料供应量比其他皂苷佐剂更为充足。一项临床试验显示,TQL-1055耐受良好、免疫应答强。Adjuvance正以TQL-1055为基础设计新的联合佐剂,以产生不同类型的免疫应答。

关于皂苷佐剂:皂苷佐剂为强效免疫刺激剂,是获得许可的临床先进的感染性疾病疫苗的重要成分,包括针对带状疱疹、疟疾、新冠肺炎和流感的疫苗。将皂苷佐剂用于免疫肿瘤学的研究也已开展。现有皂苷佐剂受限于临床耐受不良和生产工艺效率低下。绝大多数皂苷佐剂的天然原料提取自皂树树皮的内层,原料无法重复采集。

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    2022-04-30 shock_melon
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    2021-08-26 查查佳佳

    我嗯嗯我路由器WAN

    0

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    2021-08-26 医者仁者

    新冠疫苗如果加点可能效果更好

    0

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    2021-08-26 医者仁者

    几十年前中药注射液直接打肌注,中药中很多都是皂苷成分,会不会起到强效免疫刺激作用?

    0

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阐述疫苗对世界的重要性、成分、诱导抗体及 T 细胞反应、保护特征等,介绍安全性、未来开发方向,强调解决知识差距和挑战。

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研究评估流感和肺炎球菌疫苗对 HIV 感染者的影响,结果表明疫苗安全但未显著刺激免疫系统引起 HIV RNA 转录,虽有一些发现但多为阴性,未来需用更敏感标记物评估 HIV 储存库及选免疫原性疫苗。

开发基于细胞免疫的流感疫苗

介绍流感的危害及现有疫苗,分析疫苗有效性的限制因素,探讨细胞免疫在预防流感中的作用及相关疫苗的临床研究进展,强调应重视开发新一代流感疫苗。

呼吸道合胞病毒疫苗的研究进展

呼吸道合胞病毒的流行病学和全球疾病负担突显了预防方法的必要性。

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