英国布里斯托大学Adam Finn联合葡萄牙科英布拉大学中心医院Fernanda M. P. Rodrigues团队研究了葡萄牙儿童使用B群脑膜炎球菌疫苗与B群侵袭性脑膜炎球菌病的相关性。2020年12月1日，该研究发表在《美国医学会杂志》上。

四联B群脑膜炎球菌疫苗（4CMenB）是唯一用于预防幼儿B群侵袭性脑膜炎球菌疾病的疫苗，但尚无匹配的对照研究对其进行评估。

为了确定接种4CMenB与侵袭性B群脑膜炎球菌感染之间的相关性，2014年10月至2019年3月，研究组在葡萄牙31个儿科服务中心招募经实验室确诊的浸润性脑膜炎球菌病的儿童和青少年，并进行随访直至死亡或出院。在同一家医院确定各项临床资料均匹配的对照者。主要观察指标为完全接种疫苗的病例与对照组相比，B群浸润性脑膜炎球菌的感染率。

在117例浸润性脑膜炎球菌病患者中，有98例符合入组条件，其中82例患有B群浸润性脑膜炎球菌病。69例患者的年龄足够大，可接种全疫苗并产生保护。这69例病例的中位年龄为24个月，男性为42例，住院中位时间为8天。

69例病例中有5例（7.2％）进行了全疫苗接种，142例对照者中有33例（23.1％），组间差异显著。对于所有血清群浸润性脑膜炎球菌病，85例中有6例（7.1％）进行了全疫苗接种，175例对照者中有39例（22.3％），组间差异显著。

对于B群疾病，82例患者中有8例（9.8％）接种了至少1剂疫苗，168例对照者中有50例（29.8％）；对于所有血清群浸润性脑膜炎球菌病，98例患者中有11例（11.2％）接种了至少1剂疫苗，201例对照者中有61例（30.3％），组间差异均显著。

总之，在葡萄牙可获得疫苗的前5年中，与没有浸润性脑膜炎球菌疾病的配对对照者相比，发生浸润性脑膜炎球菌疾病的儿童中接种4CMenB的概率较小。

附：英文原文

Title: Association of Use of a Meningococcus Group B Vaccine With Group B Invasive Meningococcal Disease Among Children in Portugal

Author: Fernanda M. P. Rodrigues, Robin Marlow, Maria Joo Simes, Leon Danon, Shamez Ladhani, Adam Finn

Issue&Volume: 2020/12/01

Abstract:

Importance  A 4-component meningococcus group B vaccine (4CMenB) is the only vaccine in use to prevent group B invasive meningococcal disease in young children, but no matched controlled studies have evaluated it.

Objective  To determine the association between receipt of 4CMenB and invasive group B meningococcal disease.

Design, Setting, and Participants  Matched incidence density case-control study. Patients presenting from October 2014 to March 2019 were ascertained, with follow-up until death or discharge (last follow-up in June 2019) in 31 pediatric services in Portugal. Children and adolescent residents in Portugal with laboratory-confirmed invasive meningococcal disease were included. Controls, usually 2 per case, with unrelated conditions who were at the same hospital at the same time were matched for sex, age, and residence.

Exposures  Immunization with 4CMenB, ascertained from the national database (2-4 doses are recommended, depending on age).

Main Outcomes and Measures  The primary outcome was group B invasive meningococcal disease in fully vaccinated cases compared with controls. The secondary outcomes were all serogroup invasive meningococcal disease in fully vaccinated cases compared with controls and group B and all serogroup invasive meningococcal disease in cases compared with controls who received at least 1 vaccine dose.

Results  Of 117 patients with invasive meningococcal disease, 98 were eligible for inclusion and 82 had group B invasive meningococcal disease; 69 were old enough to have been fully vaccinated and considered protected. Among these 69 cases, the median (interquartile range) age was 24 (4.5-196) months, 42 were male, and the median (interquartile range) duration of hospitalization was 8 (0-86) days. Five of 69 cases (7.2%) and 33 of 142 controls (23.1%) were fully vaccinated (difference, 16.0% [95% CI, 26.3% to 5.7%]; odds ratio [OR], 0.21 [95% CI, 0.08-0.55]). For all serogroup invasive meningococcal disease, 6 of 85 cases (7.1%) and 39 of 175 controls (22.3%) were fully vaccinated (difference, 15.2% [95% CI, 24.3% to 6.1%]; OR, 0.22 [95% CI, 0.09-0.53]). For group B disease, 8 of 82 cases (9.8%) and 50 of 168 controls (29.8%) received at least 1 vaccine dose (difference, 20.0% [95% CI, 30.3% to 9.7%]; OR, 0.18 [95% CI, 0.08-0.44]) and for all serogroup invasive meningococcal disease, 11 of 98 cases (11.2%) and 61 of 201 controls (30.3%) received at least 1 vaccine dose (difference, 19.1% [95% CI, 28.8% to 9.5%]; OR, 0.23 [95% CI, 0.11-0.49]).

Conclusions and Relevance  During the first 5 years of vaccine availability in Portugal, vaccination with 4CMenB was less likely among children who developed invasive meningococcal disease compared with matched controls without invasive meningococcal disease. These findings may help inform the use of the 4CMenB vaccine in clinical practice.

DOI: 10.1001/jama.2020.20449

Source: https://jamanetwork.com/journals/jama/article-abstract/2773561