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来自西班牙的很大一部分脑膜炎球菌抗原分型系统阴性的脑膜炎球菌菌株可被接种4CMenB的青少年和婴儿的血清杀灭。

A large portion of meningococcal antigen typing system-negative meningococcal strains from spain is killed by sera from adolescents and infants immunized with 4CMenB.

作者信息

Abad R, Biolchi A, Moschioni M, Giuliani M M, Pizza M, Vázquez J A

机构信息

Reference Laboratory for Meningococci, Institute of Health Carlos III, Majadahonda, Spain

Novartis Vaccines, Siena, Italy.

出版信息

Clin Vaccine Immunol. 2015 Apr;22(4):357-60. doi: 10.1128/CVI.00669-14. Epub 2015 Jan 28.

Abstract

A new vaccine (the 4CMenB 4-component protein vaccine [Bexsero], which includes PorA, factor H-binding protein [fHbp], neisserial heparin-binding antigen [NHBA], and Neisseria adhesin A [NadA]) against serogroup B meningococci has recently been approved for use in people older than age 2 months in Europe, Australia, and Canada. Preapproval clinical efficacy studies are not feasible for invasive meningococcal disease because its incidence is low/very low, and the serum bactericidal antibody (SBA) titer (or the human SBA [hSBA] titer when human complement is used in the assay) has been used as a surrogate marker of protection. However, the hSBA assay cannot be used on a large scale, and therefore, a meningococcal antigen typing system (MATS) was developed. MATS combines conventional PorA genotyping with an enzyme-linked immunosorbent assay (ELISA) that quantifies both the expression and the cross-reactivity of antigenic variants. The assay has been used to evaluate the potential of the 4CMenB meningococcal group B vaccine to cover group B strains in several countries. Some recent data suggest that MATS is a conservative predictor of strain coverage. We used pooled sera from adolescents and infants to test by the hSBA assay 10 meningococcal group B strains isolated in Spain that were negative for the 3 antigens (n = 9) or that had very low levels of the 3 antigens (n = 1) by MATS. We found that all strains were killed by sera from adolescents and that 5 of the 10 strains were also killed, although at a low titer, by sera from infants. Our data confirm that MATS underestimates vaccine coverage.

摘要

一种针对B群脑膜炎球菌的新型疫苗(4CMenB四组分蛋白疫苗[Bexsero],包括PorA、因子H结合蛋白[fHbp]、奈瑟菌肝素结合抗原[NHBA]和奈瑟菌粘附素A[NadA])最近已在欧洲、澳大利亚和加拿大被批准用于2个月以上的人群。由于侵袭性脑膜炎球菌病的发病率低/极低,因此对其进行批准前的临床疗效研究不可行,血清杀菌抗体(SBA)滴度(或在检测中使用人补体时的人SBA[hSBA]滴度)已被用作保护的替代标志物。然而,hSBA检测无法大规模使用,因此,开发了一种脑膜炎球菌抗原分型系统(MATS)。MATS将传统的PorA基因分型与一种酶联免疫吸附测定(ELISA)相结合,该测定可量化抗原变体的表达和交叉反应性。该测定已被用于评估4CMenB B群脑膜炎球菌疫苗在几个国家覆盖B群菌株的潜力。最近的一些数据表明,MATS是菌株覆盖率的保守预测指标。我们使用青少年和婴儿的混合血清,通过hSBA检测对在西班牙分离的10株B群脑膜炎球菌菌株进行检测,这些菌株通过MATS检测对3种抗原呈阴性(n = 9)或3种抗原水平极低(n = 1)。我们发现,所有菌株都被青少年的血清杀死,10株菌株中的5株也被婴儿的血清杀死,尽管滴度较低。我们的数据证实,MATS低估了疫苗覆盖率。

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