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首页> 外文期刊>International journal of infectious diseases : >Safety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): a multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea
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Safety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): a multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea

机译：单剂量四价脑膜炎球菌结合疫苗（MenACYW-D）的安全性和免疫原性：大韩民国的多中心，盲法，随机，III期临床试验

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Objectives: To assess the safety and immunogenicity of a meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) in a Korean population. Methods: This was a phase III, blind-observer, controlled study in which participants aged 11-55 years were randomized (2:1 ratio) to a single dose of MenACYW-D or tetanus/diphtheria/acellular pertussis (Tdap) vaccine. Outcomes included rates of seroconversion against all serogroups (>=4-fold increase in antibody titer from pre-vaccination), geometric mean titers (GMTs) at days 0 and 28 based on a serum bactericidal assay using baby rabbit complement, rates of seroprotection (titer >=1:128) at day 28, and safety. Results: A total of 300 participants were enrolled in the study (200 MenACYW-D and 100 Tdap). Seroconversion rates for serogroups A, C, Y, and W-135 were 77.8%, 88.3%, 74.6%, and 92.4%, respectively, for the MenACYW-D group and 9.3%, 8.1%, 12.2%, and 8.2%, respectively, for the Tdap group. The proportions of participants with pre-vaccination titers >=1:128 were 57.3%, 12.6%, 51.5%, and 22.2% for serogroups A, C, Y, and W-135, respectively; post-vaccination rates were 98.5%, 89.4%, 96.0%, and 95.0% for the MenACYW-D group. A lower proportion of participants reported solicited reactions with MenACYW-D (46.2%) compared with Tdap (76.8%). Conclusion: A single dose of MenACYW-D was well tolerated and elicited a robust immune response in Korean adolescents and adults.
机译：目的：评估脑膜炎球菌多糖白喉类毒素结合疫苗（MenACYW-D）在韩国人群中的安全性和免疫原性。方法：这是一项III期，盲人观察，对照研究，其中11-55岁的参与者被随机分配（比例为2：1）MenACYW-D或破伤风/白喉/无细胞百日咳疫苗（Tdap）。结果包括针对所有血清群的血清转化率（接种前抗体滴度> = 4倍），基于使用幼兔补体的血清杀菌试验在第0天和第28天的几何平均滴度（GMT），血清保护率（在第28天滴度> = 1：128）和安全性。结果：共有300名参与者参加了该研究（200名MenACYW-D和100名Tdap）。对于A，C，Y和W-135血清群，MenACYW-D组的血清转化率分别为77.8％，88.3％，74.6％和92.4％，而MenACYW-D组的血清转化率分别为9.3％，8.1％，12.2％和8.2％，分别针对Tdap组。血清群A，C，Y和W-135的接种前效价> = 1：128的参与者比例分别为57.3％，12.6％，51.5％和22.2％; MenACYW-D组的疫苗接种率分别为98.5％，89.4％，96.0％和95.0％。与Tdap（76.8％）相比，参与报告的MenACYW-D引起的反应比例较低（46.2％）。结论：单剂量的MenACYW-D具有良好的耐受性，并在韩国青少年和成人中引发了强大的免疫反应。

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