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4CMenB疫苗完全接种可有效预防儿童脑膜炎球菌侵袭性疾病
作者:小柯机器人 发布时间:2023/2/7 9:49:58

西班牙纳瓦拉公共卫生研究所Jesús Castilla团队研究了B组脑膜炎球菌疫苗(4CMenB)在儿童中的有效性。相关论文于2023年2月1日发表在《新英格兰医学杂志》上。

2015年9月,基于蛋白质的四组分B型脑膜炎球菌血清群疫苗(4CMenB;Bexsero)在西班牙可供私人购买。

研究组进行了一项全国性的病例对照研究,以评估4CMenB预防儿童侵袭性脑膜炎球菌病的有效性。该研究包括2015年10月5日至2019年10月6日期间,西班牙60个月以下儿童中所有实验室确诊的侵袭性脑膜炎球菌病病例。根据出生日期和省份,每个病例患者与四名对照者匹配。使用多变量条件logistic回归对病例患者和对照组的4CMenB疫苗接种状况进行比较。

研究组将306例患者(243例[79.4%]血清B型疾病)与1224例对照者进行了比较。共有35名病例患者(11.4%)和298名对照者(24.3%)接种了至少一剂4CMenB。完全接种4CMenB疫苗(定义为至少接种2剂,根据制造商的建议进行)对任何血清群引起的侵袭性脑膜炎球菌病的有效性为76%,部分接种有效性为54%。

完全接种疫苗对B群脑膜炎球菌疾病的有效性为71%。至少一剂4CMenB的疫苗有效性对血清B组疾病为64%,对非血清B组的疾病为82%。通过使用遗传性脑膜炎球菌抗原分型系统,在44名病例患者中检测到了预期被4CMenB覆盖的血清组B菌株,这些患者均未接种疫苗。

研究结果表明,在5岁以下的儿童中,使用4CMenB完全接种疫苗可有效预防B血清群和非B血清群脑膜炎球菌侵袭性疾病。

附:英文原文

Title: Effectiveness of a Meningococcal Group B Vaccine (4CMenB) in Children

Author: Jesús Castilla, M.D., Ph.D.,, Manuel García Cenoz, M.D., Ph.D.,, Raquel Abad, Ph.D.,, Laura Sánchez-Cambronero, M.D.,, Nicola Lorusso, M.D.,, Conchita Izquierdo, Ph.D.,, Soledad Caellas Llabrés, M.D.,, Javier Roig, M.D.,, Alberto Malvar, M.D.,, Fernando González Carril, M.Sc.,, An L.D. Boone, M.D.,, Jaime Pérez Martín, M.D.,, M. Jesús Rodríguez Recio, M.D.,, Antònia Galmés, M.D.,, Arturo Caballero, M.D.,, Amós García Rojas, M.D.,, Felipe Juanas, M.D.,, Mercedes Nieto, M.D.,, Luis J. Viloria Raymundo, M.D.,, Eva Martínez Ochoa, M.D.,, Ana I. Rivas, M.D.,, Daniel Castrillejo, Ph.D.,, David Moreno Pérez, M.D.,, Ana Martínez, Ph.D.,, Eva Borràs, Ph.D.,, Amaya Sánchez Gómez, Ph.D.,, Eliseo Pastor, M.D.,, Victoria Nartallo, M.D.,, José M. Arteagoitia, M.D.,, Blanca álvarez-Fernández, R.N.,, Rocío García Pina, M.D.,, Socorro Fernández Arribas, M.D.,, Joana Vanrell, M.D.,, Sara García Hernández, R.N.,, Rita M. Mendoza, M.D.,, Manuel Méndez, M.D.,, M. Mar López-Tercero, M.D.,, ángela Fernández-Rodríguez, Ph.D.,, ángela Blanco, M.D.,, F. Javier Carrillo de Albornoz, M.D.,, José Ruiz Olivares, M.D.,, Rafael Ruiz-Montero, M.P.H.,, Aurora Limia, M.D., Ph.D.,, José A. Navarro-Alonso, M.D.,, Julio A. Vázquez, Ph.D.,, and Aurelio Barricarte, M.D., Ph.D.

Issue&Volume: 2023-02-01

Abstract:

Background

In September 2015, the four-component, protein-based meningococcal serogroup B vaccine (4CMenB; Bexsero) became available for private purchase in Spain.

Methods

We conducted a nationwide matched case–control study to assess the effectiveness of 4CMenB in preventing invasive meningococcal disease in children. The study included all laboratory-confirmed cases of invasive meningococcal disease in children younger than 60 months of age between October 5, 2015, and October 6, 2019, in Spain. Each case patient was matched with four controls according to date of birth and province. 4CMenB vaccination status of the case patients and controls was compared with the use of multivariate conditional logistic regression.

Results

We compared 306 case patients (243 [79.4%] with serogroup B disease) with 1224 controls. A total of 35 case patients (11.4%) and 298 controls (24.3%) had received at least one dose of 4CMenB. The effectiveness of complete vaccination with 4CMenB (defined as receipt of at least 2 doses, administered in accordance with the manufacturer’s recommendations) was 76% (95% confidence interval [CI], 57 to 87) against invasive meningococcal disease caused by any serogroup, and partial vaccination was 54% (95% CI, 18 to 74) effective. Complete vaccination resulted in an effectiveness of 71% (95% CI, 45 to 85) against meningococcal serogroup B disease. Vaccine effectiveness with at least one dose of 4CMenB was 64% (95% CI, 41 to 78) against serogroup B disease and 82% (95% CI, 21 to 96) against non–serogroup B disease. With the use of the genetic Meningococcal Antigen Typing System, serogroup B strains that were expected to be covered by 4CMenB were detected in 44 case patients, none of whom had been vaccinated.

Conclusions

Complete vaccination with 4CMenB was found to be effective in preventing invasive disease by serogroup B and non–serogroup B meningococci in children younger than 5 years of age.

DOI: 10.1056/NEJMoa2206433

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2206433

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:176.079
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home