四价脑膜炎球菌结合疫苗（MenACYW-TT）与常规儿科疫苗联合接种的免疫原性和安全性：一项欧洲随机对照试验。
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial.
作者信息
Martinon-Torres Federico, Virta Miia M, Koski Susanna, de la Cueva Ignacio Salamanca, Szymanski Henryk T, Bosis Samantha, Drăgănescu Anca C, Silfverdal Sven-Arne, Zambrano Betzana, Dhingra Mandeep S, B'Chir Siham, Syrkina Olga, Lyabis Olga, Vasquez Gustavo A, Rehm Christine
机构信息
Translational Paediatrics and Infectious Diseases Section, Paediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, 15701, Santiago de Compostela, Spain.
Genetics, Vaccines, and Infections Research Group (GENVIP), Healthcare Research Institute of Santiago de Compostela, University of Santiago de Compostela, 15701, Santiago de Compostela, Spain.
出版信息
Infect Dis Ther. 2025 Jul 15. doi: 10.1007/s40121-025-01190-7.
INTRODUCTION
The immunogenicity and safety of MenACYW-TT (MenQuadfi) were compared to another quadrivalent meningococcal conjugate vaccine, MCV4-TT (Nimenrix), when administered in infants alongside routine childhood vaccines in Europe.
METHODS
One set of healthy infants was randomized 1:1 to receive MenACYW-TT (group 1; n = 714) or MCV4-TT (group 2; n = 726) at age 2, 4, and 12-18 months (2 + 1 regimen) concomitantly with routine vaccines (including 10-valent pneumococcal conjugate vaccine). Another set was randomized 1:1 to receive MenACYW-TT in a 2 + 1 regimen (group 3; n = 112) or a 3 + 1 regimen at age 2, 4, 6, and 12-18 months (group 4; n = 108) concomitantly with routine vaccines (including 13-valent pneumococcal conjugate vaccine). Immune responses against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority of MenACYW-TT versus MCV4-TT was based on hSBA geometric mean titers (GMTs) 30 days post-booster (dose 3; primary endpoint) and rates of seroprotection 30 days post-dose 2 (secondary endpoint) against all vaccine meningococcal serogroups. Immune responses to co-administered vaccines and safety were also assessed. Post hoc, non-inferiority of MenACYW-TT was also assessed based on seroresponse rates 30 days post-booster.
RESULTS
Non-inferiority of MenACYW-TT versus MCV4-TT, based on GMTs post-booster, was demonstrated for serogroups C, W, and Y but not for A. GMTs against serogroups C, W, and Y were 1.5- to 4.5-fold higher with MenACYW-TT than MCV4-TT; those against serogroup A were marginally lower. Antibody responses in groups 3 and 4 against all serogroups were similar to group 1. Non-inferiority of MenACYW-TT based on seroresponse rates post-booster against all serogroups was demonstrated post hoc. No interference with concomitant routine vaccines nor safety concerns were identified.
CONCLUSIONS
Consideration of all immunogenicity and safety data generated in this study supports the incorporation of MenACYW-TT into the routine childhood vaccination schedule as a 2 + 1 regimen starting at age 6 weeks.
GOV IDENTIFIER
NCT03547271.
引言
在欧洲，将婴幼儿用ACYW-TT结合疫苗（MenQuadfi）与另一种四价脑膜炎球菌结合疫苗MCV4-TT（Nimenrix）同时与常规儿童疫苗一起接种时，比较了它们的免疫原性和安全性。
方法
一组健康婴儿按1:1随机分组，在2、4和12 - 18月龄（2 + 1接种程序）时接受ACYW-TT结合疫苗（第1组；n = 714）或MCV4-TT（第2组；n = 726），同时接种常规疫苗（包括10价肺炎球菌结合疫苗）。另一组按1:1随机分组，在2、4、6和12 - 18月龄时接受2 + 1接种程序的ACYW-TT结合疫苗（第3组；n = 112）或3 + 1接种程序（第4组；n = 108），同时接种常规疫苗（包括13价肺炎球菌结合疫苗）。使用人补体的血清杀菌试验（hSBA）测量针对A、C、W和Y血清型脑膜炎球菌的免疫反应。ACYW-TT结合疫苗相对于MCV4-TT结合疫苗的非劣效性基于加强免疫（第3剂）后30天的hSBA几何平均滴度（GMTs）（主要终点）以及第2剂后30天针对所有疫苗血清型脑膜炎球菌的血清保护率（次要终点）。还评估了对同时接种疫苗的免疫反应和安全性。事后分析中，也基于加强免疫后30天的血清反应率评估了ACYW-TT结合疫苗的非劣效性。
结果
基于加强免疫后的GMTs，ACYW-TT结合疫苗相对于MCV4-TT结合疫苗在C、W和Y血清型上显示出非劣效性，但在A血清型上未显示。ACYW-TT结合疫苗针对C、W和Y血清型的GMTs比MCV4-TT结合疫苗高1.5至4.5倍；针对A血清型的GMTs略低。第3组和第4组针对所有血清型的抗体反应与第1组相似。事后分析显示，基于加强免疫后针对所有血清型的血清反应率，ACYW-TT结合疫苗具有非劣效性。未发现对同时接种的常规疫苗有干扰，也未发现安全性问题。
结论
对本研究中产生的所有免疫原性和安全性数据的考量支持将ACYW-TT结合疫苗纳入常规儿童疫苗接种计划，采用从6周龄开始的2 + 1接种程序。
政府标识符
NCT03547271
Zotero 插件