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英国婴儿免疫接种计划中不同载体蛋白的C群脑膜炎球菌结合疫苗的互换性

Interchangeability of meningococcal group C conjugate vaccines with different carrier proteins in the United Kingdom infant immunisation schedule.

作者信息

Ladhani Shamez N, Andrews Nick J, Waight Pauline, Hallis Bassam, Matheson Mary, England Anna, Findlow Helen, Bai Xilian, Borrow Ray, Burbidge Polly, Pearce Emma, Goldblatt David, Miller Elizabeth

机构信息

Immunisation, Hepatitis and Blood Safety Department, Public Health England, London, United Kingdom.

Statistics, Modelling and Economics and Immunisation, Public Health England, London, United Kingdom.

出版信息

Vaccine. 2015 Jan 29;33(5):648-55. doi: 10.1016/j.vaccine.2014.12.018. Epub 2014 Dec 12.

DOI:10.1016/j.vaccine.2014.12.018
PMID:25510388
Abstract

An open, non-randomised study was undertaken in England during 2011-12 to evaluate vaccine antibody responses in infants after completion of the routine primary infant immunisation schedule, which included two doses of meningococcal group C (MenC) conjugate (MCC) vaccine at 3 and 4 months. Any of the three licensed MCC vaccines could be used for either dose, depending on local availability. Healthy term infants registered at participating general practices (GPs) in Hertfordshire and Gloucestershire, UK, were recruited prospectively to provide a single blood sample four weeks after primary immunisation, which was administered by the GP surgery. Vaccination history was obtained at blood sampling. MenC serum bactericidal antibody (SBA) and IgG antibodies against Haemophilus influenzae b (Hib), pertussis toxin (PT), diphtheria toxoid (DT), tetanus toxoid (TT) and thirteen pneumococcal serotypes were analysed according to MCC vaccines received. MenC SBA responses differed significantly (P<0.001) according to MCC vaccine schedule as follows: MenC SBA geometric mean titres (GMTs) were significantly lower in infants receiving a diphtheria cross-reacting material-conjugated MCC (MCC-CRM) vaccine followed by TT-conjugated MCC (MCC-TT) vaccine (82.0; 95% CI, 39-173; n=14) compared to those receiving two MCC-CRM (418; 95% CI, 325-537; n=82), two MCC-TT (277; 95% CI, 223-344; n=79) or MCC-TT followed by MCC-CRM (553; 95% CI, 322-949; n=18). The same group also had the lowest Hib geometric mean concentrations (0.60 μg/mL, 0.27-1.34) compared to 1.85 μg/mL (1.23-2.78), 2.86 μg/mL (2.02-4.05) and 4.26 μg/mL (1.94-9.36), respectively. Our results indicate that MCC vaccines with different carrier proteins are not interchangeable. When several MCC vaccines are available, children requiring more than one dose should receive MCC vaccines with the same carrier protein or, alternatively, receive MCC-TT first wherever possible.

摘要

2011年至2012年期间,在英国开展了一项开放性非随机研究,以评估婴儿完成常规初级婴儿免疫接种程序后的疫苗抗体反应,该程序包括在3个月和4个月时接种两剂C群脑膜炎球菌结合疫苗(MenC)。根据当地供应情况,三种已获许可的MenC疫苗中的任何一种都可用于任何一剂。在英国赫特福德郡和格洛斯特郡参与的全科医疗诊所(GPs)登记的健康足月儿被前瞻性招募,在初级免疫接种四周后提供一份血样,免疫接种由全科医疗诊所进行。在采血时获取疫苗接种史。根据所接种的MenC疫苗,分析了C群脑膜炎球菌血清杀菌抗体(SBA)以及针对b型流感嗜血杆菌(Hib)、百日咳毒素(PT)、白喉类毒素(DT)、破伤风类毒素(TT)和13种肺炎球菌血清型的IgG抗体。根据MenC疫苗接种程序,MenC SBA反应存在显著差异(P<0.001),如下所示:与接受两剂CRM结合的MenC疫苗(MCC-CRM)(418;95%可信区间,325-537;n=82)、两剂TT结合的MenC疫苗(MCC-TT)(277;95%可信区间,223-344;n=79)或先接种MCC-TT后接种MCC-CRM(553;95%可信区间,322-949;n=18)的婴儿相比,接受白喉交叉反应物质结合的MenC疫苗(MCC-CRM)后再接种TT结合的MenC疫苗(MCC-TT)的婴儿的MenC SBA几何平均滴度(GMTs)显著较低(82.0;95%可信区间,39-173;n=14)。与分别为1.85μg/mL(1.23-2.78)、2.86μg/mL(2.02-4.05)和4.26μg/mL(1.94-9.36)相比,同一组婴儿的Hib几何平均浓度也最低(0.60μg/mL,0.27-1.34)。我们的结果表明,具有不同载体蛋白的MenC疫苗不可互换。当有几种MenC疫苗可用时,需要接种多剂的儿童应接种具有相同载体蛋白的MenC疫苗,或者尽可能先接种MCC-TT。

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