Vesikari Timo, Forsten Aino, Bianco Veronique, Van der Wielen Marie, Miller Jacqueline M
a Vaccine Research Center; University of Tampere; Medical School ; Tampere , Finland.
b GSK Vaccines ; Wavre , Belgium.
Hum Vaccin Immunother. 2016;12(1):132-9. doi: 10.1080/21645515.2015.1058457.
We studied the persistence of serum bactericidal antibody using rabbit and human complement (rSBA/hSBA, cut-offs 1:8) 5 y after a single dose of meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT) compared with age-appropriate control vaccines in toddlers and children (NCT00427908). Children were previously randomized (3:1) to receive either MenACWY-TT or control vaccine (MenC-CRM197 in 1-<2 y olds; MenACWY-polysaccharide vaccine [Men-PS] in 2-<11 y olds). Subjects with rSBA-MenC titers <1:8 at any time point were revaccinated with MenC conjugate vaccine and discontinued from the study. A repeated measurement statistical model assessed potential selection effects due to drop-outs. At year 5 in MenACWY-TT-vaccinated-toddlers for serogroups A, C, W, and Y respectively, percentages with rSBA titers ≥1:8 were 73.5%, 77.6%, 34.7%, and 42.9%, hSBA ≥1:8 were 35.6%, 91.7%, 82.6% and 80.0%. For MenC-CRM197 recipients, 63.6% had persisting rSBA-MenC titers ≥1:8 and 90.9% had hSBA-MenC ≥1:8 (not significantly different versus MenACWY-TT for either assay: exploratory analyses). In 2-<11 y olds rSBA titers ≥1:8 in MenACWY-TT-vaccinees were 90.8%, 90.8%, 78.6%, and 78.6% and 15.4%, 100%, 0.0%, 7.7% in Men-PS-vaccinees (significantly different for serogroups A, W and Y, exploratory analyses). Serogroups A, W and Y rSBA GMTs were ≥ 26-fold higher in MenACWY-TT-vaccinees. As expected, GMTs modeled at year 5 to assess the impact of subject drop out (mainly for revaccination), appeared lower for serogroup C. No vaccine-related SAEs were reported. Antibody persistence was observed for all serogroups up to 5 y after MenACWY-TT vaccination.
我们研究了单剂量A、C、W、Y群脑膜炎球菌结合破伤风类毒素疫苗（MenACWY-TT）接种5年后，使用兔补体和人补体检测血清杀菌抗体（rSBA/hSBA，临界值1:8）的持久性，并与幼儿和儿童中年龄匹配的对照疫苗进行比较（NCT00427908）。儿童先前已按3:1随机分组，分别接受MenACWY-TT或对照疫苗（1至<2岁儿童接种MenC-CRM197；2至<11岁儿童接种A、C、W、Y群脑膜炎球菌多糖疫苗[Men-PS]）。在任何时间点rSBA-MenC滴度<1:8的受试者重新接种MenC结合疫苗并退出研究。重复测量统计模型评估了因退出而产生的潜在选择效应。在接种MenACWY-TT的幼儿中，5岁时A、C、W和Y群的rSBA滴度≥1:8的百分比分别为73.5%、77.6%、34.7%和42.9%，hSBA≥1:8的百分比分别为35.6%、91.7%、82.6%和80.0%。对于接种MenC-CRM197的受试者，63.6%的rSBA-MenC滴度持续≥1:8，90.9%的hSBA-MenC≥1:8（两种检测方法与MenACWY-TT相比均无显著差异：探索性分析）。在2至<11岁儿童中，接种MenACWY-TT的受试者rSBA滴度≥1:8的比例分别为90.8%、90.8%、78.6%和78.6%，接种Men-PS的受试者分别为15.4%、100%、0.0%和7.7%（A、W和Y群有显著差异，探索性分析）。接种MenACWY-TT的受试者中A、W和Y群的rSBA几何平均滴度（GMT）高≥26倍。正如预期的那样，为评估受试者退出（主要是重新接种）的影响而在5岁时模拟的GMT，C群似乎较低。未报告与疫苗相关的严重不良事件。在接种MenACWY-TT疫苗后长达5年的时间里，所有血清群均观察到抗体持久性。
