中国脑膜炎球菌疫苗预防接种专家共识(2023年版)

中国上市的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和联合疫苗，不同生产企业的脑膜炎球菌多糖结合疫苗的免疫程序有所不同，给实际接种工作带来困扰。本专家共识在中国脑膜炎球菌疫苗预防接种专家共识(2019年版)基础上，更新国内外流行性脑脊髓膜炎研究最新进展和脑膜炎球菌疫苗预防接种建议，供疾病预防控制和预防接种相关工作人员参考使用。     

中国脑膜炎球菌疫苗预防接种专家共识（2023年版）

中国上市的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和联合疫苗，不同生产企业的脑膜炎球菌多糖结合疫苗的免疫程序有所不同，给实际接种工作带来困扰。本专家共识在中国脑膜炎球菌疫苗预防接种专家共识（2019年版）基础上，更新国内外流行性脑脊髓膜炎研究最新进展和脑膜炎球菌疫苗预防接种建议，供疾病预防控制和预防接种相关工作人员参考使用。     

中国脑膜炎球菌疫苗预防接种专家共识

中国上市的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和联合疫苗,不同生产企业的脑膜炎球菌多糖结合疫苗的免疫程序有所不同,给实际接种工作带来困扰。本共识结合国内外研究最新进展,基于流行性脑脊髓膜炎流行特征、脑膜炎奈瑟菌菌群分布以及中国脑膜炎球菌疫苗免疫原性和安全性等研究证据,提出脑膜炎球菌疫苗预防接种建议,供预防接种人员和疾病预防控制机构人员参考使用。     

脑膜炎球菌疫苗的有效性、安全性和成本效益研究进展

流行性脑脊髓膜炎（流脑）是由脑膜炎奈瑟菌感染所致的一种严重急性呼吸道传染病。接种脑膜炎球菌疫苗是控制和预防流脑传播最有效的措施。中国上市使用的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和含脑膜炎球菌多糖结合疫苗的联合疫苗。本文重点对中国上市使用的脑膜炎球菌疫苗的有效性、安全性和成本效益研究进展进行综述,为合理使用不同类型的脑膜炎球菌疫苗预防流脑提供依据。     

A群脑膜炎球菌多糖结合疫苗的制备及其稳定性考察

目的 制备安全、有效的A群脑膜炎球菌多糖结合疫苗。方法 将A群脑膜炎球菌多糖以已二酰肼作为多糖和蛋白之间的连接子与精制破伤风类毒素结合，形成A群脑膜炎球菌多糖结合疫苗原液，加保护剂后冻干制成A群脑膜炎球菌多糖结合疫苗，检测其生化、生物学特性和安全性，并考察制品的稳定性。结果 结合疫苗各项检测结果达到质量控制标准，制品放置2年后仍保持稳定。结论 A群脑膜炎球菌多糖结合疫苗制备工艺是可行和稳定的.     

2004 — 2005年我国流行性脑脊髓膜炎病死率分析

接种疫苗是预防流行性脑脊髓膜炎（流脑）最有效、最经济的方法,在过去几十年,随着疫苗的广泛使用,流脑发病率显著下降。目前在中国上市的疫苗主要包括A、C、W、Y群单价和多价多糖脑膜炎球菌疫苗（MPV）,A、C群多糖脑膜炎球菌结合疫苗（MPCV-AC）以及A、C群脑膜炎球菌多糖结合b型流感嗜血杆菌结合联合疫苗（MPCV-AC-hib）。纵观我国脑膜炎球菌疫苗近50年的发展历程,在疫苗生产、质量控制以及相关研究方面均取得了显著成绩,但仍然面临着流脑疾病负担被低估、脑膜炎球菌疫苗免疫策略尚未完善、不同厂家脑膜炎球菌疫苗免疫程序不统一、无B群脑膜炎球菌疫苗上市等问题和挑战,为此应不断提高流脑监测手段及系统开展流脑疾病负担评价的研究以助力我国脑膜炎球菌疫苗免疫策略和免疫程序的完善,并针对流脑血清群高度可变和易发生抗原漂移的特性通过基因重组等技术研发出免疫力更长、保护效果更好的可预防所有血清群流脑的通用性疫苗。     

A群脑膜炎球菌多糖结合疫苗临床试验--安全性观察报告

目的 :了解 A群脑膜炎球菌多糖结合疫苗的安全性。方法 :于 2 0 0 2年 10月～ 2 0 0 3年 1月 ,在江苏省射阳县对 3～ 4月龄的健康婴幼儿接种 3针 A群脑膜炎球菌多糖结合疫苗 ,以多糖疫苗为对照组 ,进行安全性观察 , 期临床观察4 7人、 ～ 期临床观察 2 36人。结果 :接种 A脑膜炎球菌多糖结合疫苗各针次的副反应均以弱发热反应为主 ,发生率最高为 7.33%、最低为 0 .80 % ,对照组的弱发热反应发生率最高为 1.72 % ,最低为 0 .86 %。结论 :A群脑膜炎球菌多糖结合疫苗具有良好的安全性     

脑膜炎球菌疫苗的有效性、安全性和成本效益研究进展

目的流行性脑脊髓膜炎(流脑)是由脑膜炎奈瑟菌感染所致的一种严重急性呼吸道传染病。接种脑膜炎球菌疫苗是控制和预防流脑传播最有效的措施。中国上市使用的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和含脑膜炎球菌多糖结合疫苗的联合疫苗。本文重点对中国上市使用的脑膜炎球菌疫苗的有效性、安全性和成本效益研究进展进行综述,为合理使用不同类型的脑膜炎球菌疫苗预防流脑提供依据。     

1例接种脑膜炎球菌多糖疫苗偶合急性胃肠炎的报告

2003年洪泽县共和卫生院在儿童预防接种中遇到1例接种脑膜炎球菌多糖疫苗(A C)后,发生急性胃肠炎的病例,现报道如下。     

关于使用脑膜炎球菌疫苗的建议

预防流行性脑脊髓膜炎（流脑）的有效措施是接种疫苗。目前我国使用的有A群脑膜炎球菌多糖疫苗（Meningococcal Polysaccharide Vaccine,MPV）,A＋C群MPV,A、C、Y、W135群MPV和A＋C群脑膜炎球菌多糖结合疫苗（Meningococcal Polysaccharide Canigate Vaccine,MCV）4个品种。纳入国家免疫规划的是A群MPV和A＋C群MPV。鉴于我国流脑的发病特点和国际上使用脑膜炎球菌疫苗（Meningococcal Vaccine,MenV）的经验,对MenV使用提出以下建议：     

Priorities for research on meningococcal disease and the impact of serogroup A vaccination in the African meningitis belt

For over 100 years, large epidemics of meningococcal meningitis have occurred every few years in areas of the African Sahel and sub-Sahel known as the African meningitis belt. Until recently, the main approach to the control of these epidemics has been reactive vaccination with a polysaccharide vaccine after an outbreak has reached a defined threshold and provision of easy access to effective treatment but this approach has not prevented the occurrence of new epidemics. Meningococcal conjugate vaccines, which can prevent meningococcal carriage and thus interrupt transmission, may be more effective than polysaccharide vaccines at preventing epidemics. Because the majority of African epidemics have been caused by serogroup A meningococci, a serogroup A polysaccharide/tetanus toxoid protein conjugate vaccine (PsA–TT) has recently been developed. Results from an initial evaluation of the impact of this vaccine on meningococcal disease and meningococcal carriage in Burkina Faso have been encouraging.     

WHO position paper,Meningococcal A conjugate vaccine: Updated guidance,February 2015

This article presents the World Health Organization’s (WHO) updated recommendations on the use of meningococcal vaccines excerpted from the WHO position paper on Meningococcal A conjugate vaccine: updated guidance, February 2015, published in the Weekly Epidemiological Record [1].A position paper on meningococcal vaccines was published in 2011 and its recommendations remain valid [2]. This update adds to the previous recommendations specifically concerning routine immunization of infants and young children in the African meningitis belt with meningococcal A conjugate vaccine.Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of the Meningococcal A conjugate vaccine were discussed by SAGE in October 2014; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2014/october/presentations_background_docs/en/.     

B群脑膜炎球菌疫苗研究进展

脑膜炎奈瑟菌（Neisseria Meningitidis,Nm）感染仍然严重威胁人群健康,接种疫苗是预防该类疾病的有效手段。根据荚膜多糖的特征,Nm分为A、B、C、W135、Y等不同的血清群。A、C、W135、Y群Nm多糖疫苗以及多糖-蛋白结合疫苗,已经得到广泛应用并证明了其有效性。由于B群Nm菌株的荚膜多糖免疫原性较低,并且与人体神经组织具有同源性,因此B群Nm多糖不能用于疫苗抗原成分。近年来,国际上开展了大量B群Nm蛋白疫苗研究工作,以疫苗外膜蛋白为基础的疫苗研究,以及反向疫苗学技术在B群疫苗研究中的应用,使B群Nm疫苗的研究取得了长足进展。某些B群疫苗显示出良好的免疫原性和有效性,并且已经有B群蛋白疫苗获得许可并规模化应用。     

A half-century of meningococcal vaccines

The first safe and effective vaccine for the prevention of invasive meningococcal disease was created fifty years ago. The vaccine employed a novel platform, polysaccharide capsular antigen, based on the discovery that anticapsular antibody conferred protective immunity in humans. As with most new paradigms in vaccinology, it derived from important basic research from other scientific disciplines over the preceding years. The success of the first monovalent polysaccharide vaccine in nearly eliminating invasive meningococcal disease in military settings led to accelerated advances in polysaccharide vaccine development against other serogroups of meningococcus and other encapsulated pathogens. As gaps in vaccine efficacy arose over the past half-century, new vaccine technologies and approaches were developed to address the challenges. Several of these, including conjugate vaccines and “reverse vaccinology” led to other novel, successful vaccines that have had a significant, favorable global impact on invasive meningococcal disease. The history of meningococcal vaccine discovery may provide insights into the future of vaccine efforts against other infectious threats.     

Chemistry of a new investigational quadrivalent meningococcal conjugate vaccine that is immunogenic at all ages

Meningococcal disease is a serious medical condition that can prove fatal within hours in otherwise healthy individuals. Disease incidence is highest in infants, yet there is no broadly protective quadrivalent vaccine that covers this age group. A new investigational quadrivalent meningococcal glycoconjugate vaccine against meningococcal serogroups A, C, W-135, and Y (MenACWY-CRM, Novartis Vaccines, Siena, Italy), has been developed to meet this medical need. This article discusses the vaccine technology behind MenACWY-CRM, focusing on the heritage of CRM₁₉₇, the conjugation chemistry, the sizing of the oligosaccharides, and the advantages that these may confer on the vaccine. We highlight the differences between available vaccines and look at the clinical experience with vaccines against other diseases, demonstrating the importance of each component to the immunogenicity of conjugate vaccines. The specific technological approach, including conjugation of meningococcal oligosaccharides of defined length to the CRM₁₉₇ protein, has led to a vaccine that has the potential to provide broad meningococcal protection against serogroups A, C, W-135, and Y for all ages.     

The Global Meningococcal Initiative: recommendations for reducing the global burden of meningococcal disease

The Global Meningococcal Initiative (GMI) is composed of an international group of scientists, clinicians and public health officials with expertise in meningococcal immunology, epidemiology and prevention. The primary goal of the GMI is the promotion of the global prevention of invasive meningococcal disease through education and research. The GMI members reviewed global meningococcal disease epidemiology, immunization strategies, and research needs. Over the past decade, substantial advances in meningococcal vaccine development have occurred and much has been learned about prevention from countries that have incorporated meningococcal vaccines into their immunization programs. The burden of meningococcal disease is unknown for many parts of the world because of inadequate surveillance, which severely hampers evidence-based immunization policy. As the field of meningococcal vaccine development advances, global surveillance for meningococcal disease needs to be strengthened in many regions of the world. For countries with meningococcal vaccination policies, research on vaccine effectiveness and impact, including indirect effects, is crucial for informing policy decisions. Each country needs to tailor meningococcal vaccination policy according to individual country needs and knowledge of disease burden. Innovative approaches are needed to introduce and sustain meningococcal vaccination programs in resource-poor settings with a high incidence of meningococcal disease.     

The impact of pre-existing antibody on subsequent immune responses to meningococcal A-containing vaccines

Major epidemics of serogroup A meningococcal meningitis continue to affect the African meningitis belt. The development of an affordable conjugate vaccine against the disease became a priority for World Health Organization (WHO) in the late 1990s. Licensing of meningococcal vaccines has been based on serological correlates of protection alone, but such correlates might differ in different geographical regions. If high pre-vaccination antibody concentrations/titers impacts on the response to vaccination and possibly vaccine efficacy, is not clearly understood. We set out to define the pre-vaccination Meningococcal group A (Men A) antibody concentrations/titers in The Gambia and study their impact on the immunogenicity of Men A containing vaccines.