An open-label, phase IV randomised controlled trial of two schedules of a four-component meningococcal B vaccine in UK preterm infants.

IF 4.3 3区医学 Q1 PEDIATRICS

Archives of Disease in Childhood Pub Date : 2024-10-18 DOI:10.1136/archdischild-2024-327040

Anna Calvert, Nick Andrews, Sheula Barlow, Ray Borrow, Charlotte Black, Barbara Bromage, Jeremy Carr, Paul Clarke, Andrew C Collinson, Karen Few, Naomi Hayward, Christine E Jones, Kirsty Le Doare, Shamez N Ladhani, Jennifer Louth, Georgia Papadopoulou, Michelle Pople, Tim Scorrer, Matthew D Snape, Paul T Heath

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引用次数: 0

Abstract

Objective: To compare immunological responses of preterm infants to a four-component meningococcal B vaccine (4CMenB; Bexsero) following a 2+1 vs a 3+1 schedule, and to describe reactogenicity of routine vaccines.

Design: An open-label, phase IV randomised study conducted across six UK sites.

Setting: Neonatal units, postnatal wards, community recruitment following discharge.

Participants: 129 preterm infants born at a gestation of <35 weeks (64 in group 1 (2+1), 65 in group 2 (3+1)) were included in the analysis. Analysis was completed for postprimary samples from 125 participants (59 in group 1, 66 in group 2) and for postbooster samples from 118 participants (59 in both groups).

Interventions: Infants randomised to 4CMenB according to a 2+1 or a 3+1 schedule, alongside routine vaccines.

Main outcome measures: Serum bactericidal antibody (SBA) assays performed at 5, 12 and 13 months of age: geometric mean titres (GMTs) and proportions of infants achieving titres ≥4 compared between groups.

Results: There were no significant differences in SBA GMTs between infants receiving a 2+1 compared with a 3+1 schedule following primary or booster vaccination, but a significantly higher proportion of infants had an SBA titre ≥4 against strain NZ98/254 (porin A) at 1 month after primary vaccination using a 3+1 compared with a 2+1 schedule (3+1: 87% (95% CI 76 to 94%), 2+1: 70% (95% CI 56 to 81%), p=0.03).At 12 weeks of age those in the 3+1 group, who received a dose of 4CMenB, had significantly more episodes of fever >38.0°C than those in the 2+1 group who did not (group 2+1: 2% (n=1); 3+1: 14% (n=9); p=0.02).

Conclusions: Both schedules were immunogenic in preterm infants, although a lower response against strain NZ98/254 was seen in the 2+1 schedule; ongoing disease surveillance is important in understanding the clinical significance of this difference.

Trial registration number: NCT03125616.

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英国早产儿接种四价脑膜炎球菌 B 型疫苗两种接种方案的开放标签 IV 期随机对照试验。

目的比较早产儿对四联脑膜炎球菌 B 疫苗（4CMenB；Bexsero）2+1 与 3+1 接种程序的免疫反应，并描述常规疫苗的致反应性：设计：一项开放标签、IV 期随机研究，在英国六个地点进行：环境：新生儿病房、产后病房、出院后社区招募：129 名早产儿，妊娠期为 3 个月：干预措施：按照 2+1 或 3+1 计划随机为婴儿接种 4CMenB 以及常规疫苗：5、12和13个月大时进行血清杀菌抗体（SBA）检测：比较各组间的几何平均滴度（GMT）和滴度≥4的婴儿比例：结果：接种 2+1 和 3+1 疫苗的婴儿在初次接种或加强接种后的 SBA GMT 没有明显差异，但接种 3+1 和 2+1 疫苗的婴儿在初次接种后 1 个月对 NZ98/254 株（孔蛋白 A）的 SBA 滴度≥4 的比例明显更高（3+1：87% (95% CI 76 至 94%)，2+1：70% (95% CI 56 至 81%)，P=0.03）。在 12 周大时，3+1 组中接受了一剂 4CMenB 的患者发烧 >38.0°C 的次数明显多于 2+1 组中未接受 4CMenB 的患者（2+1 组：2%（n=1）；3+1 组：14%（n=9）；P=0.02）：两种方案对早产儿均有免疫原性，但2+1方案对NZ98/254菌株的反应较低；持续的疾病监测对了解这种差异的临床意义非常重要：NCT03125616.

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Archives of Disease in Childhood 医学-小儿科

CiteScore

5.80

自引率

3.80%

发文量

291

审稿时长

3-6 weeks

期刊介绍： Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.