Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Vaccine Innovation Center-Korea University (KU) Medicine (VIC-K), Seoul, Republic of Korea.
Front Immunol. 2024 May 13;15:1382944. doi: 10.3389/fimmu.2024.1382944. eCollection 2024.
As coronavirus disease-2019 (COVID-19) becomes an endemic disease, the virus continues to evolve and become immunologically distinct from previous strains. Immune imprinting has raised concerns about bivalent mRNA vaccines containing both ancestral virus and Omicron variant. To increase efficacy against the predominant strains as of the second half of 2023, the updated vaccine formulation contained only the mRNA of XBB.1.5 sublineage. We conducted a multicenter, test-negative, case-control study to estimate XBB.1.5 monovalent vaccine effectiveness (VE) and present the results of an interim analysis with data collected in November 2023. Patients who underwent COVID-19 testing at eight university hospitals were included and matched based on age (19-49, 50-64, and ≥65 years) and sex in a 1:1 ratio. VE was calculated using the adjusted odds ratio derived from multivariable logistic regression. Of the 992 patients included, 49 (5.3%) received the XBB.1.5 monovalent vaccine at least 7 days before COVID-19 testing. Patients with COVID-19 (cases) were less likely to have received the XBB.1.5 monovalent vaccine (case 3.5% vs. control 7.2%, p=0.019) and to have a history of COVID-19 within 6 months (2.2% vs. 4.6%, p=0.068). In contrast, patients with COVID-19 were more likely to be healthcare workers (8.2% vs. 3.0%, p=0.001) and to have chronic neurological diseases (16.7% vs. 11.9%, p=0.048). The adjusted VE of the XBB.1.5 monovalent mRNA vaccine was 56.8% (95% confidence interval: 18.7-77.9%). XBB.1.5 monovalent mRNA vaccine provided significant protection against COVID-19 in the first one to two months after vaccination.
随着新型冠状病毒病-2019（COVID-19）成为一种地方病，该病毒继续进化并在免疫学上与以前的毒株不同。免疫印迹引起了人们对包含原始病毒和奥密克戎变体的二价 mRNA 疫苗的担忧。为了提高针对截至 2023 年下半年主要毒株的疗效，更新的疫苗配方仅包含 XBB.1.5 亚谱系的 mRNA。我们进行了一项多中心、病例对照研究，以评估 XBB.1.5 单价疫苗的有效性（VE），并展示了 2023 年 11 月收集的数据的中期分析结果。在 8 所大学医院进行 COVID-19 检测的患者被纳入研究，并按年龄（19-49 岁、50-64 岁和≥65 岁）和性别进行 1:1 匹配。使用多变量逻辑回归得出的调整比值比计算 VE。在 992 名患者中，49 名（5.3%）患者在 COVID-19 检测前至少 7 天接种了 XBB.1.5 单价疫苗。COVID-19 患者（病例）接种 XBB.1.5 单价疫苗的可能性较低（病例 3.5% vs. 对照组 7.2%，p=0.019），且在 6 个月内有 COVID-19 病史的可能性也较低（2.2% vs. 4.6%，p=0.068）。相比之下，COVID-19 患者更有可能是医护人员（8.2% vs. 3.0%，p=0.001）和患有慢性神经系统疾病（16.7% vs. 11.9%，p=0.048）。XBB.1.5 单价 mRNA 疫苗的调整 VE 为 56.8%（95%置信区间：18.7-77.9%）。XBB.1.5 单价 mRNA 疫苗在接种后一到两个月内对 COVID-19 提供了显著的保护。
