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首页> 外文会议>Lancefield International Symposium on Streptococci and Streptococcal Diseases >A double-blind, randomized phase II trial of thesafety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults
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A double-blind, randomized phase II trial of thesafety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults

机译：一种双盲，随机期II试验，对健康成人的26岁的26岁群体的疫苗疫苗

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Background: GrAS causes illness ranging from uncomplicated pharyngitis to life-threatening necrotizing fasciitis, toxic shock and rheumatic fever. Attempts to develop an M protein-based vaccine have been hindered by the fact that some M proteins elicit both protective antibodies and antibodies that cross-react with human tissues. New molecular techniques have allowed this obstacle to be largely overcome. Methods: We performed a phase II trial of a 26-valent GrAS vaccine comprising four recombinant proteins containing N-terminal peptides from 26 M proteins (plus Spa=27) of common pharyngitis, invasive, and/or rheumatogenic serotypes adsorbed to AIOH3. Subjects were screened for good health and underwent baseline cardiac auscultation, echocardiography, ECG, and screening for human tissue-cross-reacting antibodies. Subjects (mean age=33.6, range 18.9-50.9) were randomized in a 70:20 ratio to receive either GrAS or control vaccine, Havrix~(TM), intramuscularly at 0, 1 and 6 months, with clinical and laboratory follow-up for safety and assay of type-specific M antibodies by quantitative ELISA. Results: No vaccine-associated serious adverse events (SAE) occurred. Most adverse events (AEs) were at the injection site and were mild and self-limited. Systemic AEs were uncommon and did not differ between the 2 groups. No subject developed clinical or laboratory evidence of rheumatogenicity or nephritoge-nicity, and no induction of human tissue-reactive antibodies was demonstrated. The vaccine was highly immunogenic, eliciting an antibody response to the majority of group A streptococcus serotypes associated with pharyngitis, acute rheumatic fever, and invasive disease in NorthAmerica. Conclusions: The 26-valent GrAS vaccine was well-tolerated and immunogenic in healthy adults; studies in adolescents and children are warranted.
机译：背景：GRAS导致疾病从无与重解的咽炎到危及生命的坏死性筋膜炎，毒性休克和风湿热。由于一些M蛋白引发了与人组织交叉反应的保护抗体和抗体的事实，已经阻碍了发展M基于蛋白质的疫苗的尝试。新的分子技术允许这种障碍在很大程度上被克服。方法：我们进行了26 vall Gras疫苗的II期试验，所述26 valent Gras疫苗包含含有来自26m蛋白（加Spa = 27）的N-末端肽的四个重组蛋白质的常见咽炎，侵袭性和/或类动物血清型吸附到AiOH3。筛选受试者良好的健康和接受基线心脏听诊，超声心动图，心电图和用于人类组织交叉反应抗体的筛选。受试者（平均年龄= 33.6，范围为18.9-50.9），以70:20的比率随机化，以接受GRAS或对照疫苗，HAVRIX〜（TM），肌肉注射，在0,1和6个月，临床和实验室随访用于通过定量ELISA的特异性M抗体的安全性和测定。结果：没有发生疫苗相关的严重不良事件（SAE）。大多数不良事件（AES）在注射部位，并轻度和自我限制。全身AES罕见，2组之间没有区别。没有受试者开发了临床或实验室证据的流离失心或肾脏 - 尼古，并且证明了人类组织反应性抗体的诱导。疫苗是高度免疫原性的，引发对大多数组的抗体反应与北非咽炎，急性风湿热和侵袭性疾病相关的血型链球菌血清型。结论：26 vall Gras疫苗在健康成年人中耐受良好耐受和免疫原性;有必要的青少年和儿童研究。

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