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异源加强针用蛋白 COVID-19 疫苗(NVX-CoV2373)在健康成年人中的免疫原性和安全性:与 mRNA 疫苗的比较分析。

Immunogenicity and safety of heterologous booster with protein-based COVID-19 vaccine (NVX-CoV2373) in healthy adults: A comparative analysis with mRNA vaccines.

机构信息

Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan; School of Medicine, National Taiwan University College of Medicine, Taipei City, Taiwan.

Graduate Institute of Microbiology, College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

J Formos Med Assoc. 2024 Mar;123(3):340-346. doi: 10.1016/j.jfma.2023.10.012. Epub 2023 Nov 22.

DOI:10.1016/j.jfma.2023.10.012
PMID:37996322
Abstract

BACKGROUND

Information on the protein-based severe acute respiratory syndrome (SARS-CoV-2) vaccine-NVX-CoV2373 (Novavax), as a heterologous booster remains limited. We investigated the immunogenicity and adverse events of NVX-CoV2373 as a second booster and compared them with those of mRNA vaccines in healthy adults.

METHODS

Healthcare workers who had received an mRNA vaccine (mRNA-1273 or BNT-162b2) as the first booster (third dose) 12 weeks prior were recruited. Participants voluntarily received either NVX-CoV2373 or an mRNA vaccine as a second booster. Participants with a history of SARS-CoV-2 infection were excluded. The primary outcomes included serum anti-SARS-CoV-2 spike protein (SP) and neutralizing antibody titers against B.1.1.7 (Alpha), B.1.1.529 (Omicron) BA2, and BA5 variants on the 28th day after the boost. Secondary outcomes included new SARS-CoV-2 infections and adverse events reported during the study period.

RESULTS

A total of 160 participants were enrolled in this study. Compared with the mRNA vaccination group (n = 59), the NVX-CoV2373 vaccination group (n = 101) had significantly lower anti-SARS-CoV-2 SP antibody titers and neutralizing antibody titers against all variants tested after the boost. During the study period, higher rates of new SARS-CoV-2 infections and a lower incidence of adverse events were observed in the NVX-CoV2373 vaccination group. No significant differences in cellular immune responses were observed between the two groups.

CONCLUSION

Compared to a homologous mRNA booster vaccination, heterologous boosters with NVX-CoV2373 showed lower antibody responses, a higher incidence of new SARS-CoV-2 infections, and fewer adverse events.

摘要

背景

关于基于蛋白质的严重急性呼吸综合征(SARS-CoV-2)疫苗-NVX-CoV2373(诺瓦瓦克斯)的信息,作为异源加强剂仍然有限。我们研究了 NVX-CoV2373 作为第二加强剂的免疫原性和不良事件,并将其与健康成年人中的 mRNA 疫苗进行了比较。

方法

招募了 12 周前接受过 mRNA 疫苗(mRNA-1273 或 BNT-162b2)作为第一加强剂(第三剂)的医护人员。参与者自愿接受 NVX-CoV2373 或 mRNA 疫苗作为第二加强剂。排除有 SARS-CoV-2 感染史的参与者。主要结局包括第 28 天加强后血清抗 SARS-CoV-2 刺突蛋白(SP)和针对 B.1.1.7(Alpha)、B.1.1.529(Omicron)BA2 和 BA5 变异株的中和抗体滴度。次要结局包括研究期间报告的新 SARS-CoV-2 感染和不良事件。

结果

本研究共纳入 160 名参与者。与 mRNA 疫苗接种组(n=59)相比,NVX-CoV2373 疫苗接种组(n=101)在加强后 SARS-CoV-2 SP 抗体滴度和针对所有测试变异株的中和抗体滴度明显较低。在研究期间,NVX-CoV2373 疫苗接种组的新 SARS-CoV-2 感染率较高,不良事件发生率较低。两组之间的细胞免疫反应无显著差异。

结论

与同源 mRNA 加强剂接种相比,异源加强剂 NVX-CoV2373 显示出较低的抗体反应、较高的新 SARS-CoV-2 感染发生率和较少的不良事件。

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