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肺炎球菌结合疫苗的研发与评估:临床试验与对照试验

Development and evaluation of pneumococcal conjugate vaccines: clinical trials and control tests.

作者信息

Lee Lucia H, Lee Chi-Jen, Frasch Carl E

机构信息

Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852-1448, USA.

出版信息

Crit Rev Microbiol. 2002;28(1):27-41. doi: 10.1080/1040-840291046678.

Abstract

Streptococcus pneumoniae is a major cause of pneumonia, meningitis, and otitis media and is responsible for disease in young children, the elderly, and immunocompromised individuals. Emerging high-level resistance to penicillin, multiple antibiotics, and tolerance to vancomycin emphasizes the importance of preventing pneumococcal infection by alternative methods such as immunization. The development of pneumococcal conjugate vaccines using the same carrier proteins as those used in Hemophilus influenzae type b vaccines has enhanced the immune response in infants and children compared with polysaccharide vaccines and has significantly improved the ability to prevent pneumococcal disease in this population worldwide. Here we review the clinical trials of multivalent pneumococcal conjugate vaccines under evaluation, identify potential carrier proteins considered for development of future pneumococcal conjugate vaccines, discuss issues regarding licensure of new candidate vaccines from a clinical trial and quality control perspective, and alternative vaccine strategies for the prevention of pneumococcal disease.

摘要

肺炎链球菌是肺炎、脑膜炎和中耳炎的主要病因,也是导致幼儿、老年人和免疫功能低下者患病的原因。新出现的对青霉素、多种抗生素的高水平耐药性以及对万古霉素的耐受性凸显了通过免疫等替代方法预防肺炎球菌感染的重要性。使用与b型流感嗜血杆菌疫苗相同载体蛋白开发的肺炎球菌结合疫苗,与多糖疫苗相比,增强了婴幼儿的免疫反应,并显著提高了全球该人群预防肺炎球菌疾病的能力。在此,我们综述了正在评估的多价肺炎球菌结合疫苗的临床试验,确定了未来肺炎球菌结合疫苗开发中考虑的潜在载体蛋白,从临床试验和质量控制角度讨论了新候选疫苗的许可问题,以及预防肺炎球菌疾病的替代疫苗策略。

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