一项随机试验，比较CRM或TT结合四价脑膜炎球菌疫苗在学龄前接受过CRM或TT结合C群脑膜炎球菌疫苗的青少年中的免疫原性和安全性。
Randomized Trial to Compare the Immunogenicity and Safety of a CRM or TT Conjugated Quadrivalent Meningococcal Vaccine in Teenagers who Received a CRM or TT Conjugated Serogroup C Vaccine at Preschool Age.
作者信息
Ishola David A, Andrews Nick, Waight Pauline, Yung Chee-Fu, Southern Jo, Bai Xilian, Findlow Helen, Matheson Mary, England Anna, Hallis Bassam, Findlow Jamie, Borrow Ray, Miller Elizabeth
机构信息
From the *Department of Immunisation, Hepatitis and Blood Transfusion, Public Health England (PHE), London, United Kingdom; †Department of Infection and Population Health, University College London, London, United Kingdom; ‡Statistics, Modelling, and Economics Department, PHE London, United Kingdom; §Department of Clinical Epidemiology, Communicable Disease Centre, Tan Tock Seng Hospital, Singapore; ¶Vaccine Evaluation Unit, PHE, Manchester Medical Microbiology Partnership, Manchester Royal Infirmary, Manchester, United Kingdom; and ‖ Microbiology Services, PHE, Porton Down, Salisbury, United Kingdom.
出版信息
Pediatr Infect Dis J. 2015 Aug;34(8):865-74. doi: 10.1097/INF.0000000000000750.
BACKGROUND
Protection after meningococcal C (MenC) conjugate (MCC) vaccination in early childhood is short-lived. Boosting with a quadrivalent vaccine in teenage years, a high-risk period for MenC disease, should protect against additional serogroups but might compromise MenC response. The carrier protein in the primary MCC vaccine determines the response to MCC booster in toddlers, but the relationship between primary vaccine and booster given later is unclear. This study compared responses to a CRM-conjugated or tetanus toxoid (TT)-conjugated MenACWY vaccine in teenagers primed with different MCC vaccines at preschool age.
METHODS
Ninety-three teenagers (16-19 years), who were previously randomized at age 3-6 years to receive single-dose MCC-CRM or MCC-TT, were randomized to receive either MenACWY-CRM or MenACWY-TT booster. Serum bactericidal antibodies (SBA, protective titer ≥ 8) were measured before, 1 month and 6 or 9 months after boosting.
RESULTS
Preboosting, MCC-TT-primed teenagers had significantly higher MenC SBA titers than those MCC-CRM-primed (P = 0.02). Postboosting, both MenACWY vaccines induced protective SBA titers to all 4 serogroups in most participants (≥ 98% at 1 month and ≥ 90% by 9 months postboost). The highest MenC SBA titers were seen in those MCC-TT-primed and MenACWY-TT-boosted [geometric mean titer (GMT) ~ 22,000] followed by those boosted with MenACWY-CRM irrespective of priming (GMT ~ 12,000) and then those MCC-CRM-primed and MenACWY-TT-boosted (GMT ~ 5500). The estimated postbooster MenC SBA decline beyond 1 month was ~40% as time since booster doubles. Both vaccines were well tolerated with no attributable serious adverse events.
CONCLUSION
Both MenACWY vaccines safely induced protective sustained antibody responses against all targeted serogroups in MCC-primed teenagers.
背景
幼儿期接种脑膜炎球菌C（MenC）结合疫苗（MCC）后的保护作用持续时间较短。在青少年时期（MenC疾病的高危期）接种一剂四价疫苗进行加强免疫，应能预防其他血清群，但可能会影响对MenC的免疫反应。初级MCC疫苗中的载体蛋白决定了幼儿对MCC加强免疫的反应，但初级疫苗与后期接种的加强疫苗之间的关系尚不清楚。本研究比较了在学龄前接种不同MCC疫苗的青少年对CRM结合或破伤风类毒素（TT）结合的MenACWY疫苗的反应。
方法
93名青少年（16 - 19岁），他们在3 - 6岁时曾被随机分组接受单剂量MCC - CRM或MCC - TT，现在被随机分组接受MenACWY - CRM或MenACWY - TT加强免疫。在加强免疫前、加强免疫后1个月以及6或9个月测量血清杀菌抗体（SBA，保护效价≥8）。
结果
加强免疫前，接种MCC - TT的青少年的MenC SBA效价比接种MCC - CRM的青少年显著更高（P = 0.02）。加强免疫后，两种MenACWY疫苗在大多数参与者中均诱导出针对所有4个血清群的保护性SBA效价（加强免疫后1个月≥98%，9个月后≥90%）。MenC SBA效价最高的是那些接种MCC - TT并接受MenACWY - TT加强免疫的青少年[几何平均效价（GMT）约为22,000]，其次是无论初始接种何种疫苗均接受MenACWY - CRM加强免疫的青少年（GMT约为12,000），然后是接种MCC - CRM并接受MenACWY - TT加强免疫的青少年（GMT约为5500）。加强免疫后1个月后MenC SBA效价的下降估计约为40%，即自加强免疫后时间翻倍。两种疫苗耐受性良好，无相关严重不良事件。
结论
两种MenACWY疫苗均能在接种MCC的青少年中安全地诱导出针对所有目标血清群的持续性保护性抗体反应。
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