PDF(Pubmed)
Abstract：
The 4-component meningococcal serogroup B (MenB) vaccine, 4CMenB, the first broadly protective, protein-based MenB vaccine to be licensed, is now registered in more than 50 countries worldwide. Real-world evidence (RWE) from the last decade confirms its effectiveness and impact, with infant immunization programs showing vaccine effectiveness of 71-95% against invasive MenB disease and cross-protection against non-B serogroups, including a 69% decrease in serogroup W cases in 4CMenB-eligible cohorts in England. RWE from different countries also demonstrates the potential for additional moderate protection against gonorrhea in adolescents. The real-world safety profile of 4CMenB is consistent with prelicensure reports. Use of the endogenous complement human serum bactericidal antibody (enc-hSBA) assay against 110 MenB strains may enable assessment of the immunological effectiveness of multicomponent MenB vaccines in clinical trial settings. Equitable access to 4CMenB vaccination is required to better protect all age groups, including older adults, and vulnerable groups through comprehensive immunization policies.
Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis(meningococcus), is rare but often devastating and can be deadly. Effective vaccines are available, including vaccines against meningococcal serogroup B disease. In 2013, the 4-component meningococcal serogroup B vaccine, 4CMenB, became the first broadly protective, protein-based vaccine against serogroup B to be licensed, with the second (bivalent vaccine, MenB-FHbp) licensed the following year. 4CMenB is now registered in more than 50 countries, in the majority, for infants and all age groups. In the US, it is approved for individuals aged 10–25 years. Evidence from immunization programs in the last decade, comparing vaccinated and unvaccinated individuals and the same population before and after vaccination, confirms the effectiveness and positive impact of 4CMenB against serogroup B disease. This also demonstrates that 4CMenB can provide protection against invasive diseases caused by other meningococcal serogroups. Furthermore, N. meningitidis is closely related to the bacterium that causes gonorrhea, N. gonorrhoeae, and emerging real-world evidence suggests that 4CMenB provides additional moderate protection against gonococcal disease. The safety of 4CMenB when given to large numbers of infants, children, adolescents, and adults is consistent with the 4CMenB safety profile reported before licensure.For the future, it would be beneficial to address differences among national guidelines for the recommended administration of 4CMenB, particularly where there is supportive epidemiological evidence but no equitable access to vaccination. New assays for assessing the potential effectiveness of meningococcal serogroup B vaccines in clinical trials are also required because serogroup B strains circulating in the population are extremely diverse across different countries.
Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis(meningococcus), is rare but often devastating and can be deadly. Effective vaccines are available, including vaccines against meningococcal serogroup B disease. In 2013, the 4-component meningococcal serogroup B vaccine, 4CMenB, became the first broadly protective, protein-based vaccine against serogroup B to be licensed, with the second (bivalent vaccine, MenB-FHbp) licensed the following year. 4CMenB is now registered in more than 50 countries, in the majority, for infants and all age groups. In the US, it is approved for individuals aged 10–25 years. Evidence from immunization programs in the last decade, comparing vaccinated and unvaccinated individuals and the same population before and after vaccination, confirms the effectiveness and positive impact of 4CMenB against serogroup B disease. This also demonstrates that 4CMenB can provide protection against invasive diseases caused by other meningococcal serogroups. Furthermore, N. meningitidis is closely related to the bacterium that causes gonorrhea, N. gonorrhoeae, and emerging real-world evidence suggests that 4CMenB provides additional moderate protection against gonococcal disease. The safety of 4CMenB when given to large numbers of infants, children, adolescents, and adults is consistent with the 4CMenB safety profile reported before licensure.For the future, it would be beneficial to address differences among national guidelines for the recommended administration of 4CMenB, particularly where there is supportive epidemiological evidence but no equitable access to vaccination. New assays for assessing the potential effectiveness of meningococcal serogroup B vaccines in clinical trials are also required because serogroup B strains circulating in the population are extremely diverse across different countries.
摘要：
4组分脑膜炎球菌血清群B（MenB）疫苗，4CMenB,第一个广泛保护性的，基于蛋白质的MenB疫苗将获得许可，现已在全球50多个国家注册。过去十年的真实世界证据(RWE)证实了它的有效性和影响，婴儿免疫计划显示，针对侵袭性MenB疾病的疫苗效力为71-95％，并且对非B血清群具有交叉保护作用，包括在英格兰符合4CMenB标准的队列中，血清群W病例减少了69%。来自不同国家的RWE也证明了在青少年中额外适度保护淋病的潜力。4CMenB的实际安全性与许可前报告一致。使用针对110种MenB菌株的内源性补体人血清杀菌抗体（enc-hSBA）测定可以评估多组分MenB疫苗在临床试验环境中的免疫学有效性。需要公平获得4CMenB疫苗接种，以更好地保护所有年龄组，包括老年人,通过综合免疫政策和弱势群体。
侵袭性脑膜炎球菌病，由脑膜炎奈瑟菌（脑膜炎球菌）引起，是罕见的，但往往是毁灭性的，可能是致命的。有有效的疫苗，包括针对脑膜炎球菌血清群B疾病的疫苗。2013年，4组分脑膜炎球菌血清群B疫苗，4CMenB,成为第一个广泛保护的，基于蛋白质的针对血清群B的疫苗将获得许可，第二种(二价疫苗，MenB-FHbp）第二年获得许可。4CMenB现已在50多个国家注册，在大多数情况下，适用于婴儿和所有年龄组。在美国,它适用于10-25岁的个人。过去十年免疫计划的证据，比较接种疫苗和未接种疫苗的个体以及接种疫苗前后的相同人群，证实了4CMenB对血清群B疾病的有效性和积极影响。这也证明4CMenB可以提供针对由其他脑膜炎球菌血清群引起的侵袭性疾病的保护。此外，脑膜炎奈瑟菌与引起淋病的细菌密切相关，淋病奈瑟菌,和新兴的现实世界的证据表明，4CMenB提供额外的中度保护对淋球菌疾病。4CMenB给大量婴儿时的安全性，孩子们,青少年,成年人与许可前报告的4CMenB安全概况一致。为了未来,解决建议管理4CMenB的国家指南之间的差异将是有益的，特别是在有流行病学支持性证据但没有公平接种疫苗的情况下。还需要用于评估脑膜炎球菌血清群B疫苗在临床试验中的潜在有效性的新测定法，因为在人群中传播的血清群B菌株在不同国家之间非常多样化。
侵袭性脑膜炎球菌病，由脑膜炎奈瑟菌（脑膜炎球菌）引起，是罕见的，但往往是毁灭性的，可能是致命的。有有效的疫苗，包括针对脑膜炎球菌血清群B疾病的疫苗。2013年，4组分脑膜炎球菌血清群B疫苗，4CMenB,成为第一个广泛保护的，基于蛋白质的针对血清群B的疫苗将获得许可，第二种(二价疫苗，MenB-FHbp）第二年获得许可。4CMenB现已在50多个国家注册，在大多数情况下，适用于婴儿和所有年龄组。在美国,它适用于10-25岁的个人。过去十年免疫计划的证据，比较接种疫苗和未接种疫苗的个体以及接种疫苗前后的相同人群，证实了4CMenB对血清群B疾病的有效性和积极影响。这也证明4CMenB可以提供针对由其他脑膜炎球菌血清群引起的侵袭性疾病的保护。此外，脑膜炎奈瑟菌与引起淋病的细菌密切相关，淋病奈瑟菌,和新兴的现实世界的证据表明，4CMenB提供额外的中度保护对淋球菌疾病。4CMenB给大量婴儿时的安全性，孩子们,青少年,成年人与许可前报告的4CMenB安全概况一致。为了未来,解决建议管理4CMenB的国家指南之间的差异将是有益的，特别是在有流行病学支持性证据但没有公平接种疫苗的情况下。还需要用于评估脑膜炎球菌血清群B疫苗在临床试验中的潜在有效性的新测定法，因为在人群中传播的血清群B菌株在不同国家之间非常多样化。
