Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study
Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study
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DOI：
10.1016/s0140-6736(16)31921-3
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发表时间：
2016-12-03
期刊：
影响因子：
168.9
通讯作者：
Ladhani, Shamez N.
中科院分区：
文献类型：
--
作者：
Parikh, Sydel R.;Andrews, Nick J.;Ladhani, Shamez N.
背景2015年9月，英国成为第一个将多组分B组脑膜炎双球菌(MenB)疫苗(4CMenB，Bexsero)引入公共资助的国家免疫计划的国家。为2个月和4个月的婴儿提供了减少的两剂注射计划，同时为3个月和4个月的婴儿提供了机会性的追赶。4CMenB对73-88%的MenB菌株有保护作用。我们的目的是评估4CMenB在英国符合疫苗资格的婴儿中的有效性和影响。方法英国公共卫生(PHE)通过临床、公共卫生和实验室报告相结合的方式加强对脑膜炎双球菌疾病的监测。实验室确认的脑膜炎双球菌病病例将与公共卫生署当地卫生保护小组、全科医生和医院临床医生进行跟踪，以收集人口统计数据、疫苗接种史、临床表现和结果。对于2015年9月1日至2016年6月30日期间诊断的病例，使用筛查方法评估疫苗有效性。通过比较前4年符合疫苗接种条件的儿童和不符合疫苗接种条件的儿童中MenB病例的数量来评估影响。有资格接种常规疫苗的婴儿中4CMenB的发现覆盖率很高，达到95。6月龄时一剂5%，两剂88 3 6%。两剂疫苗的有效率为82。9%(95%可信区间24。1-95。2)针对所有MenB病例，相当于94的疫苗效力。2%，而最高预测的MenB毒株覆盖率为88%。与预接种期相比，符合疫苗资格的队列中的MenB病例的发病率比(IRR)降低了50%(37例比平均74例；IRR为0。50[95%CI 0.36-0。71]；p=0。0001)，无论婴儿的疫苗接种状况或预测的MenB菌株覆盖率。即使在对符合疫苗条件和不符合疫苗条件的儿童的疾病趋势进行调整后，也观察到了类似的下降。解释说，两剂4CMenB接种计划在预防婴儿MenB疾病方面非常有效。在该计划的前10个月，符合疫苗资格的婴儿的病例减少了一半。虽然正在进行的国家监测将继续监测该方案的长期影响，但这些发现标志着在抗击脑膜炎双球菌疾病的斗争中向前迈出了一步，并将有助于保证疫苗可预防这种致命感染。
Background In September, 2015, the UK became the first country to introduce the multicomponent group B meningococcal (MenB) vaccine (4CMenB, Bexsero) into a publicly funded national immunisation programme. A reduced two-dose priming schedule was offered to infants at 2 months and 4 months, alongside an opportunistic catch-up for 3 month and 4 month olds. 4CMenB was predicted to protect against 73-88% of MenB strains. We aimed to assess the effectiveness and impact of 4CMenB in vaccine-eligible infants in England.Methods Public Health England (PHE) undertakes enhanced surveillance of meningococcal disease through a combination of clinical, public health, and laboratory reporting. Laboratory-confirmed cases of meningococcal disease are followed up with PHE local health protection teams, general practitioners, and hospital clinicians to collect demographic data, vaccination history, clinical presentation, and outcome. For cases diagnosed between Sept 1, 2015, and June 30, 2016, vaccine effectiveness was assessed using the screening method. Impact was assessed by comparing numbers of cases of MenB in vaccine-eligible children to equivalent cohorts in the previous 4 years and to cases in vaccine-ineligible children.Findings Coverage of 4CMenB in infants eligible for routine vaccination was high, achieving 95 . 5% for one dose and 88 3 6% for two doses by 6 months of age. Two-dose vaccine effectiveness was 82 . 9% (95% CI 24 . 1-95 . 2) against all MenB cases, equivalent to a vaccine effectiveness of 94 . 2% against the highest predicted MenB strain coverage of 88%. Compared with the prevaccine period, there was a 50% incidence rate ratio (IRR) reduction in MenB cases in the vaccine-eligible cohort (37 cases vs average 74 cases; IRR 0 . 50 [ 95% CI 0 . 36-0 . 71]; p= 0 . 0001), irrespective of the infants' vaccination status or predicted MenB strain coverage. Similar reductions were observed even after adjustment for disease trends in vaccine-eligible and vaccine-ineligible children.Interpretation The two-dose 4CMenB priming schedule was highly effective in preventing MenB disease in infants. Cases in vaccine-eligible infants halved in the first 10 months of the programme. While ongoing national surveillance will continue to monitor the longer-term impact of the programme, these findings represent a step forward in the battle against meningococcal disease and will help reassure that the vaccine protects against this deadly infection.