ChAdOx1 nCoV-19 (AZD1222)疫苗在6-17岁儿童中的安全性和免疫原性:一项2期单盲随机对照试验(COV006)的最终结果

IF 3.5
Vaccine Pub Date : 2025-08-30 Epub Date: 2025-08-25 DOI:10.1016/j.vaccine.2025.127597
Grace Li, Natalie G Marchevsky, Grace Macaulay, Parvinder Aley, Hannah Baughan, Emma Plested, Sagida Bibi, Federica Cappuccini, Saul N Faust, Paul T Heath, Jill Muller, Hannah Robinson, Marion Roderick, Matthew Snape, David Smith, Rinn Song, Xinxue Liu, Teresa Lambe, Andrew J Pollard
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引用次数: 0

摘要

背景:为应对世界卫生组织(世卫组织)于2020年宣布的冠状病毒大流行,启动了儿童COVID-19疫苗接种规划。10种COVID-19疫苗获得了世卫组织紧急使用清单,但只有5种疫苗被批准用于儿童。ChAdOx1 nCoV-19 (AZD1222)被批准用于成人双剂量方案。我们之前报道了ChAdOx1 nCoV-19在儿童中具有免疫原性的2期研究的中期结果,与成人相当。随访12个月后报告最终结果。方法:在四个英国中心进行单盲、随机对照试验,招募261名儿童和青少年(6-17岁)。参与者接受了两剂ChAdOx1 nCoV-19或Bexsero疫苗(对照组)。主要终点是安全性(疫苗接种后28天的不良事件和整个过程中的严重不良事件),次要终点是免疫原性(通过SARS-CoV-2抗刺突酶联免疫吸附试验(ELISA)和酶联免疫吸附斑点(ELISpot)测量)。结果:报告了5例严重不良事件和4例特别关注的不良事件。没有一例与研究疫苗接种有关,也没有死亡病例。6-11岁参与者抗尖峰(武汉)ELISA的几何平均滴度(GMTs)在基线时为1 EU/ml (95% CI 1-2),而在D364时为796 EU/ml (95% CI 161-3948, n =4)。在12-17岁的参与者中,基线时的gmt为1 EU/ml (95% CI 1-2, n=3),而D364(2个剂量方案,间隔112天)时的gmt为1432 EU/ml (95% CI 2337-6083, n=6),而D364(2个剂量方案,间隔28天)时的gmt为3 EU/ml (95% CI 0-62),基线时的gmt为392 EU/ml (95% CI 24, 6493, n=3)。结论:ChAdOx1 nCoV-19双剂量方案在试验人群中具有免疫原性和安全性。未报告与疫苗相关的严重不良事件。在没有发生突破性感染的参与者中,免疫反应持续了12个月。该试验在ISRCTN注册,试验号为15638344。资助:该研究由卫生和社会保健部通过国家卫生研究所和阿斯利康公司资助。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: Final results of a phase 2, single-blind, randomised controlled trial (COV006).

Background: Paediatric COVID-19 vaccination programmes were initiated in response to the coronavirus pandemic declared by the World Health Organisation (WHO) in 2020. Ten COVID-19 vaccines received WHO Emergency Use Listing, however, only five were approved for use in children. ChAdOx1 nCoV-19 (AZD1222) was approved in adults in a two-dose regimen. We previously reported interim findings of a phase 2 study of ChAdOx1 nCoV-19 in children with immunogenicity, comparable with adults. Final results after 12 month follow-up are reported.

Methods: Single-blind, randomised controlled trial across four UK centres, recruiting 261 children and adolescents (aged 6-17 years). Participants received either two doses of ChAdOx1 nCoV-19 or Bexsero vaccine (controls). The primary outcome was safety (adverse events for 28 days following vaccination and serious adverse events throughout), and secondary outcome was immunogenicity (measured by SARS-CoV-2 anti-spike enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immunosorbent spot (ELISpot)).

Findings: Five serious adverse events and four adverse events of special interest were reported. None were related to study vaccinations, and there were no deaths. Geometric mean titres (GMTs) from an anti-spike (Wuhan) ELISA in participants aged 6-11 years were 1 EU/ml (95% CI 1-2) at baseline versus 796 EU (95% CI 161-3948, n =4) at D364. In participants aged 12-17 years, GMTs were 1 EU/ml (95% CI 1-2, n=3) at baseline versus 1432 EU/ml (95% CI 2337-6083; n=6) at D364 (2 dose regimen at 112-day interval), compared to 3 EU/ml (95% CI 0-62) at baseline versus 392 EU/ml (95% CI 24, 6493; n=3) at D364 (2 dose regimen at a 28-day interval).

Interpretation: A two-dose regimen of ChAdOx1 nCoV-19 was immunogenic and safe in the trial population. No vaccine-related serious adverse events were reported. Immune responses persisted to 12 months in participants who did not experience breakthrough infection, This trial was registered with ISRCTN, trial number 15638344.

Funding: The study was funded by the Department of Health and Social Care, through the National Institute for Health Research, and AstraZeneca.

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