Hellenbrand Wiebke, Koch Judith, Harder Thomas, Bogdan Christian, Heininger Ulrich, Tenenbaum Tobias, Terhardt Martin, Vogel Ulrich, Wichmann Ole, von Kries Rüdiger
Immunization Unit, Robert Koch Institute, Berlin, Germany.
Mikrobiologisches Institut - Klinische Mikrobiologie, Immunologie und Hygiene, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Universitätsklinikum Erlangen, Erlangen, Germany.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2015 Nov;58(11-12):1314-43. doi: 10.1007/s00103-015-2253-z.
In December 2013 Bexsero® became available in Germany for vaccination against serogroup B meningococci (MenB). In August 2015 the German Standing Committee on Vaccination (STIKO) endorsed a recommendation for use of this vaccine in persons at increased risk of invasive meningococcal disease (IMD). This background paper summarizes the evidence underlying the recommendation. Bexsero® is based on surface protein antigens expressed by about 80% of circulating serogroup B meningococci in Germany. The paper reviews available data on immunogenicity and safety of Bexsero® in healthy children and adolescents; data in persons with underlying illness and on the effectiveness in preventing clinical outcomes are thus far unavailable.STIKO recommends MenB vaccination for the following persons based on an individual risk assessment: (1) Persons with congenital or acquired immune deficiency or suppression. Among these, persons with terminal complement defects and properdin deficiency, including those under eculizumab therapy, are at highest risk with reported invasive meningococcal disease (IMD) incidences up 10,000-fold higher than in the general population. Persons with asplenia were estimated to have a ~ 20-30-fold increased risk of IMD, while the risk in individuals with other immune defects such as HIV infection or hypogammaglobulinaemia was estimated at no more than 5-10-fold higher than the background risk. (2) Laboratory staff with a risk of exposure to N. meningitidis aerosols, for whom an up to 271-fold increased risk for IMD has been reported. (3) Unvaccinated household (-like) contacts of a MenB IMD index case, who have a roughly 100-200-fold increased IMD risk in the year after the contact despite chemoprophylaxis. Because the risk is highest in the first 3 months and full protective immunity requires more than one dose (particularly in infants and toddlers), MenB vaccine should be administered as soon as possible following identification of the serogroup of the index case.
2013年12月，Bexsero®在德国上市，用于预防B群脑膜炎球菌（MenB）感染。2015年8月，德国疫苗接种常设委员会（STIKO）批准了一项建议，即在侵袭性脑膜炎球菌病（IMD）风险增加的人群中使用该疫苗。本背景文件总结了该建议所依据的证据。Bexsero®基于德国约80%循环B群脑膜炎球菌表达的表面蛋白抗原。本文回顾了Bexsero®在健康儿童和青少年中的免疫原性和安全性的现有数据；目前尚无关于潜在疾病患者的数据以及预防临床结局有效性的数据。STIKO根据个体风险评估，建议对以下人群接种MenB疫苗：（1）先天性或获得性免疫缺陷或抑制的人群。其中，终末补体缺陷和备解素缺陷患者，包括接受依库珠单抗治疗的患者，风险最高，报告的侵袭性脑膜炎球菌病（IMD）发病率比普通人群高10000倍。据估计，脾切除患者患IMD的风险增加约20 - 30倍，而其他免疫缺陷个体（如HIV感染或低丙种球蛋白血症）的风险估计比背景风险高不超过5 - 10倍。（2）有接触脑膜炎奈瑟菌气溶胶风险的实验室工作人员，据报告其患IMD的风险增加高达271倍。（3）未接种疫苗的MenB IMD索引病例的家庭（类似家庭）接触者，尽管进行了化学预防，但在接触后的一年内患IMD的风险仍大致增加100 - 200倍。由于风险在前3个月最高，且完全的保护性免疫需要多剂接种（特别是在婴儿和幼儿中），因此在确定索引病例的血清群后应尽快接种MenB疫苗。
