Lancet Infect Dis:II价艰难梭菌疫苗III期临床研究失败

2020-09-16 MedSci原创 MedSci原创

类毒素A和B二价艰难梭菌疫苗不能降低高风险人群的艰难梭菌感染风险

艰难梭菌感染造成了沉重的公共卫生负担,且目前尚无有效的疫苗,近日研究人员考察了艰难梭菌类毒素疫苗的有效性、免疫原性和安全性。

本次多中心III期临床研究在美国、加拿大、拉丁美洲、欧洲和亚太地区27个国家的326家医院开展,50岁及以上的艰难梭菌感染高风险人群参与,患者有两次以上住院史,并且在过去12个月内接受过全身抗生素治疗,参与者随机接受一个包含类毒素A和B的艰难梭菌类毒素候选疫苗或安慰剂疫苗,在第0、7和30天肌肉注射一剂(0.5mL)。研究的主要结果是疫苗预防症状性艰难梭菌感染的疗效。

9302名参与者随机分配到艰难梭菌疫苗组(n=6201)或安慰剂组(n=3101)。99.5%的参与者至少接受了一剂疫苗。本研究在第一次中期分析后因无效而终止。艰难梭菌疫苗组中,在11697.2人-年的危险期内报告了34例艰难梭菌感染(0.29例感染/100人-年),而安慰剂组在5789.4人-年的危险期内报告了16例艰难梭菌感染(0.28例/100人-年),疫苗有效性为-5.2%。在艰难梭菌疫苗组中,6113名参与者中有2847名(46.6%)报告了注射后30天内不良事件,而安慰剂组3057名受试者中有1282名(41.9%)出现不良事件。艰难梭菌疫苗组的1662名(27.2%)参与者报告了至少一次严重的不良事件,而安慰剂组的851名(27.8%)参与者报告了至少一次严重不良事件。

研究认为,类毒素A和B二价艰难梭菌疫苗不能降低高风险人群的艰难梭菌感染风险。

原始出处:

Guy de Bruyn et al. Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial.Lancet Infect Dis. September 15,2020.

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    2021-06-24 howi
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    2021-01-06 juliusluan78
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    2020-09-16 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

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