台湾健康成人九种同源或异源COVID-19疫苗加强方案的安全性、免疫原性和突破性感染：一项前瞻性研究

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-06-18 DOI:10.1016/j.vaccine.2025.127383

Wen-Pin Tseng , Jhong-Lin Wu , Chien-Hao Lin , Chun-Min Kang , Ming-Yi Chung , Ya-Fan Lee , Shey-Ying Chen , Min-Chi Lu , Wen-Chien Ko , Ping-Ing Lee , Po-Ren Hsueh

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引用次数: 0

摘要

COVID-19大流行需要多种疫苗接种策略来增强免疫保护。本研究旨在评估台湾SARS-CoV-2-naïve人群中9种不同疫苗接种方案的免疫原性、反应原性和突破感染。方法从2021年12月至2022年5月，784名完成同源或异源原疫苗和第一次加强疫苗接种的健康成年人接受了第二次加强剂量，共9次疫苗接种组合。接种疫苗后7天监测反应原性。免疫原性在基线、增强后1个月和6个月采用罗氏和雅培抗刺突抗体测定和替代病毒中和试验（sVNT）进行评估。在六个月的随访期间记录突破性感染，以评估疫苗的效果。结果所有方案均在第二次增强后1个月显著提高体液免疫应答。同源mRNA-1273 （MMM）组显示出最高的抗体水平，尽管参与者年龄较大且合并症较多。6个月后，所有组的抗体水平都有所下降，但MMM组始终保持最高水平。蛋白亚单位疫苗MVC-COV1901诱导的抗体水平较低，但表现出良好的反应性，具有较少的全身不良事件。各组之间的突破感染率各不相同，在同源ChAdOx1初级疫苗接种后接受mRNA-1273或MVC-COV1901增强剂的参与者观察到的感染风险相当。无严重感染、住院或死亡报告。结论同种和异源COVID-19增强方案安全有效，其中mRNA-1273提供最强的体液免疫。这些发现支持有针对性的加强战略，以维持人群免疫力和管理大流行。

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Safety, immunogenicity, and breakthrough infection of nine homologous or heterologous COVID-19 vaccination booster regimens in healthy adults: A prospective study in Taiwan

Background

The COVID-19 pandemic necessitated diverse vaccination strategies to enhance immune protection. This study aimed to evaluate the immunogenicity, reactogenicity, and breakthrough infection of nine distinct vaccination regimens involving homologous or heterologous second booster doses in a SARS-CoV-2-naïve population in Taiwan.

Methods

From December 2021 to May 2022, 784 healthy adults who had completed either homologous or heterologous prime and first booster vaccinations received a second booster dose, resulting in nine vaccination combinations. Reactogenicity was monitored for seven days post-vaccination. Immunogenicity was assessed using Roche and Abbott anti-spike antibody assays and a surrogate virus neutralization test (sVNT) at baseline, one month, and six months post-booster. Breakthrough infections during a six-month follow-up period were recorded to evaluate vaccine performance.

Results

All regimens significantly boosted humoral immune responses at one month post-second booster. The homologous mRNA-1273 (MMM) group exhibited the highest antibody levels, despite participants having older age and more comorbidities. Antibody levels declined at six months across all groups, but the MMM group consistently maintained the highest levels. The protein subunit vaccine MVC-COV1901 induced lower antibody levels but demonstrated a favorable reactogenicity profile, with fewer systemic adverse events. Breakthrough infection rates varied among groups, with comparable infection risks observed in participants receiving mRNA-1273 or MVC-COV1901 boosters following a homologous ChAdOx1 primary vaccination. No severe infections, hospitalizations, or deaths were reported.

Conclusions

Homologous and heterologous COVID-19 booster regimens are safe and effective, with mRNA-1273 providing the strongest humoral immunity. These findings support tailored booster strategies to maintain population immunity and manage the pandemic.

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.