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英格兰和威尔士对C群脑膜炎球菌结合疫苗的上市后监测更新:有效性、保护血清学关联验证以及群体免疫持续时间的模型预测

Updated postlicensure surveillance of the meningococcal C conjugate vaccine in England and Wales: effectiveness, validation of serological correlates of protection, and modeling predictions of the duration of herd immunity.

作者信息

Campbell Helen, Andrews Nick, Borrow Ray, Trotter Caroline, Miller Elizabeth

机构信息

Immunisation, Hepatitis and Blood Safety Department, Health Protection Agency Centre for Infections, 61 Colindale Avenue, London NW9 5EQ, UK.

出版信息

Clin Vaccine Immunol. 2010 May;17(5):840-7. doi: 10.1128/CVI.00529-09. Epub 2010 Mar 10.

Abstract

Meningococcal serogroup C conjugate (MCC) vaccines were licensed in the United Kingdom more than 10 years ago based on correlates of protection that had previously been established for serogroup C-containing polysaccharide vaccines by using the serum bactericidal antibody (SBA) assay. These correlates of protection were subsequently validated against postlicensure estimates of observed vaccine effectiveness up to 7 to 9 months after the administration of the MCC vaccine. Vaccine effectiveness was, however, shown to fall significantly more than 1 year after the administration of a 3-dose course in infancy. Despite this finding, the marked impact on serogroup C disease has been sustained, with the lowest recorded incidence (0.02 case per 100,000 population) in the 2008-2009 epidemiological year, mainly due to the indirect herd immunity effect of the vaccine in reducing carriage. Updated estimates of vaccine effectiveness through 30 June 2009 confirmed high short-term protection after vaccination in infancy, at 97% (95% confidence interval [CI], 91% to 99%), falling to 68% (95% CI, -63% to 90%) more than a year after vaccination. The observed vaccine effectiveness more than 12 months postvaccination was consistent with measured declining SBA levels, but confidence intervals were imprecise; vaccine effectiveness estimates were consistent with SBA titers of 1:4 or 1:8 as correlates of long-term protection after a primary course in infants. Modeling suggested that protection against carriage persists for at least 3 years and predicted the stabilization of serogroup C disease at low levels (fewer than 50 cases per year) up to 2015-2016.

摘要

脑膜炎球菌C群结合疫苗(MCC)在10多年前于英国获得许可,其依据的是此前通过血清杀菌抗体(SBA)检测为含C群多糖疫苗确立的保护相关性。这些保护相关性随后通过MCC疫苗接种后长达7至9个月的许可后观察到的疫苗效力估计值得到了验证。然而,在婴儿期接种3剂疫苗后的1年多时间里,疫苗效力显著下降。尽管有这一发现,但对C群疾病的显著影响一直持续,在2008 - 2009年流行病学年度记录到的发病率最低(每10万人0.02例),这主要归因于疫苗在减少携带方面的间接群体免疫效应。截至2009年6月30日的疫苗效力更新估计值证实,婴儿期接种疫苗后短期保护效果良好,为97%(95%置信区间[CI],91%至99%),接种疫苗1年多后降至68%(95%CI, - 63%至90%)。接种疫苗12个月后观察到的疫苗效力与测量到的SBA水平下降一致,但置信区间不精确;疫苗效力估计值与婴儿期初级接种后作为长期保护相关性的1:4或1:8的SBA滴度一致。模型表明,对携带的保护至少持续3年,并预测到2015 - 2016年C群疾病将稳定在低水平(每年少于50例)。

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