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加拿大国家免疫咨询委员会关于加拿大可用的四价脑膜炎球菌疫苗更新情况的总结。

Summary of the National Advisory Committee on Immunization's Update on quadrivalent meningococcal vaccines available in Canada.

作者信息

Henry B

机构信息

NACI Meningococcal Working Group Chair.

Deputy Provincial Health Officer, Ministry of Health, Victoria, BC.

出版信息

Can Commun Dis Rep. 2015 Apr 20;41(Suppl 3):17-18. doi: 10.14745/ccdr.v41is3a05.

Abstract

BACKGROUND

Invasive meningococcal disease (IMD) has an overall mortality of approximately 10% and up to 35% of survivors may experience long term sequelae. Canada's National Advisory Committee on Immunization (NACI) recommends immunization with a quadrivalent conjugate meningococcal vaccine of individuals who are at increased risk of IMD due to an underlying medical condition or have a high risk of exposure to . Use of a conjugate vaccine, either monovalent or quadrivalent, is recommended for a routine adolescent booster dose at around 12 years of age.

OBJECTIVE

To review and update the evidence on the use of quadrivalent (serogroups A, C, Y and W-135) conjugate meningococcal vaccines and vaccination schedules used in Canada following the approval of a new quadrivalent meningococcal vaccine conjugated to the tetanus toxoid (Men-C-ACYW-TT, Nimenrix™).

METHODS

NACI reviewed the knowledge synthesis performed by the Meningococcal Working Group, including information on the IMD burden of disease; safety, immunogenicity, efficacy and effectiveness of the new vaccine; currently used vaccine schedules; and other aspects of the overall immunization strategy. Following the review of evidence, NACI voted on specific recommendations.

RESULTS

A total of 21 studies were reviewed for immunogenicity and 12 studies for safety data relating to Men-C-ACYW-TT. Information from two additional studies assessing immunogenicity and safety of a quadrivalent meningococcal vaccine conjugated to the diphtheria toxoid (Men-C-ACYW-DT, Menactra®) in children 9 and 12 months of age was also reviewed. A good immune response and an acceptable safety profile when compared to the monovalent conjugate meningococcal vaccines (Men-C-C) were demonstrated by both vaccines in all the reviewed studies. For children less than 2 years of age, NACI continues to recommend the use of Men-C-ACYW-CRM (Menveo™) vaccine.

CONCLUSION

The new and complete set of current recommendations for conjugate meningococcal vaccines will be published in the updated "Meningococcal" chapter in the in the near future. The top surveillance and research priorities are: determining the coverage and impact of immunization (including carriage and herd immunity) on IMD in Canada; determining the duration of protection/immunity to allow the assessment of recommendations for booster doses of conjugate quadrivalent vaccines; comparative studies of the three available quadrivalent conjugate vaccines in the general population and high-risk groups; and the immunogenicity and safety of co-administration of quadrivalent vaccines with routine age appropriate vaccines, including the newly authorized meningococcal B vaccine.

摘要

背景

侵袭性脑膜炎球菌病(IMD)的总体死亡率约为10%,高达35%的幸存者可能会经历长期后遗症。加拿大国家免疫咨询委员会(NACI)建议,因潜在医疗状况而患IMD风险增加或有高暴露风险的个体接种四价结合脑膜炎球菌疫苗。对于12岁左右的青少年常规加强剂量,建议使用单价或四价结合疫苗。

目的

在一种新的与破伤风类毒素结合的四价脑膜炎球菌疫苗(Men-C-ACYW-TT,Nimenrix™)获批后,回顾并更新加拿大使用的四价(A、C、Y和W-135血清群)结合脑膜炎球菌疫苗及疫苗接种计划的相关证据。

方法

NACI审查了脑膜炎球菌工作组进行的知识综合,包括有关IMD疾病负担的信息;新疫苗的安全性、免疫原性、效力和有效性;当前使用的疫苗接种计划;以及总体免疫策略的其他方面。在审查证据后,NACI就具体建议进行了投票。

结果

共审查了21项关于免疫原性的研究和12项关于Men-C-ACYW-TT安全性数据的研究。还审查了另外两项评估9个月和12个月大儿童中与白喉类毒素结合的四价脑膜炎球菌疫苗(Men-C-ACYW-DT,Menactra®)免疫原性和安全性的研究。在所有审查的研究中,两种疫苗与单价结合脑膜炎球菌疫苗(Men-C-C)相比,均表现出良好的免疫反应和可接受的安全性。对于2岁以下儿童,NACI继续建议使用Men-C-ACYW-CRM(Menveo™)疫苗。

结论

关于结合脑膜炎球菌疫苗的最新一套完整建议将在不久的将来发表在更新后的《加拿大免疫指南》“脑膜炎球菌”章节中。首要的监测和研究重点是:确定免疫接种(包括带菌情况和群体免疫)对加拿大IMD的覆盖率和影响;确定保护/免疫持续时间,以便评估结合四价疫苗加强剂量的建议;在一般人群和高危人群中对三种可用的四价结合疫苗进行比较研究;以及四价疫苗与常规适龄疫苗(包括新获批的B型脑膜炎球菌疫苗)联合接种的免疫原性和安全性。

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