婴儿同时接种B群脑膜炎球菌（4CMenB）和C群脑膜炎球菌（MenC-CRM）疫苗的免疫原性和安全性：一项3b期随机对照试验。
Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial.
作者信息
P Safadi Marco Aurelio, Martinon-Torres Federico, Weckx Lily Yin, Moreira Edson Duarte, da Fonseca Lima Eduardo Jorge, Mensi Ilhem, Calabresi Marco, Toneatto Daniela
机构信息
Santa Casa de São Paulo School of Medical Sciences and CDEC, São Paulo, Brazil.
Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
出版信息
Vaccine. 2017 Apr 11;35(16):2052-2059. doi: 10.1016/j.vaccine.2017.03.002. Epub 2017 Mar 18.
BACKGROUND
After implementation of routine infant MenC vaccination, MenB remains a serious cause of meningococcal disease, yet to be targeted by vaccination programs in several countries. This study (NCT01339923) investigated the immunogenicity and safety of MenC CRM-conjugated vaccine (MenC-CRM) concomitantly administered with MenB vaccine (4CMenB).
METHODS
Infants (N=251) were randomised 1:1 to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM alone (Group 2) at 3 and 5months (M3, M5) and a booster at 12months of age (M12), and pneumococcal vaccine at M3, M5, M7, M12. Antibody responses to meningococcal vaccines were measured at M3, M6, M12, and M13. Non-inferiority of MenC-CRM response in Group 1 vs Group 2 was demonstrated at M6 and M13, if the lower limit of the 95% confidence interval (LL95%CI) of the difference in percentage of infants with hSBA titres ≥1:8 was >-10%. Sufficiency of MenB response was achieved if LL95%CI of the percentage of infants with hSBA titres ≥1:4 against fHbp, NadA and PorA strains was ≥70% at M6 or ≥75% at M13. Adverse events (AEs) were collected for 7days post-vaccination, and serious AEs (SAEs) and medically attended AEs throughout the study.
RESULTS
Non-inferiority of MenC response in Group 1 vs Group 2 (LL95%CI -6.4% [M6]; -5.2% [M13]) and sufficiency of MenB response in Group 1 (LL95%CI 92%, 90%, 89% [M6]; 97%, 92%, 93% [M13] against fHbp, NadA, PorA, respectively) were demonstrated. Higher rates of mild to moderate solicited AEs were reported in Group 1. Unsolicited AEs and SAEs incidences were similar across groups.
CONCLUSIONS
Concomitant administration of MenC-CRM and 4CMenB in infants was immunogenic, resulting in non-inferior responses against MenC compared to MenC-CRM alone and demonstration of sufficient immune response to MenB, after primary and booster vaccination. Reactogenicity was higher for concomitant vaccines administration, but no safety concerns were identified.
背景
在实施常规婴儿C群脑膜炎球菌疫苗接种后，B群脑膜炎球菌仍是脑膜炎球菌病的一个严重病因，在几个国家的疫苗接种计划中尚未将其作为目标。本研究（NCT01339923）调查了C群脑膜炎球菌CRM结合疫苗（MenC-CRM）与B群脑膜炎球菌疫苗（4CMenB）同时接种的免疫原性和安全性。
方法
251名婴儿按1:1随机分组，在3个月和5个月龄（M3、M5）时接受4CMenB和MenC-CRM（第1组）或单独接受MenC-CRM（第2组），并在12个月龄（M12）时进行加强接种，在M3、M5、M7、M12时接种肺炎球菌疫苗。在M3、M6、M12和M13时测量对脑膜炎球菌疫苗的抗体反应。如果hSBA滴度≥1:8的婴儿百分比差异的95%置信区间下限（LL95%CI）＞-10%，则在M6和M13时证明第1组中MenC-CRM反应不劣于第2组。如果hSBA滴度≥1:4的婴儿针对fHbp、NadA和PorA菌株的百分比的LL95%CI在M6时≥70%或在M13时≥75%，则实现了对B群脑膜炎球菌的充分反应。接种疫苗后7天收集不良事件（AE），在整个研究过程中收集严重不良事件（SAE）和需要就医的不良事件。
结果
证明第1组中MenC反应不劣于第2组（LL95%CI -6.4%[M6]；-5.2%[M13]），且第1组中对B群脑膜炎球菌的反应充分（针对fHbp、NadA、PorA的LL95%CI在M6时分别为92%、90%、89%；在M13时分别为97%、92%、93%）。第1组报告的轻度至中度主动报告的不良事件发生率较高。各组间非主动报告的不良事件和严重不良事件发生率相似。
结论
婴儿同时接种MenC-CRM和4CMenB具有免疫原性，与单独接种MenC-CRM相比，对C群脑膜炎球菌的反应不劣，并且在初次和加强接种后对B群脑膜炎球菌显示出充分的免疫反应。同时接种疫苗的反应原性较高，但未发现安全问题。
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