成人对肌内注射二价（GI.1/GII.4）诺如病毒疫苗免疫反应的持久性

Persistence of the Immune Response to an Intramuscular Bivalent (GI.1/GII.4) Norovirus Vaccine in Adults.

作者信息

Leroux-Roels Geert, Atmar Robert L, Cramer Jakob P, Escudero Ian, Borkowski Astrid

机构信息

Center for Vaccinology (CEVAC), Ghent University and University Hospital, 9000 Ghent, Belgium.

Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX 77030, USA.

出版信息

Vaccines (Basel). 2025 Jan 17;13(1):82. doi: 10.3390/vaccines13010082.

DOI:10.3390/vaccines13010082

PMID:39852862

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11768790/

Abstract

BACKGROUND

Major global economic and health burdens due to norovirus gastroenteritis could be addressed by an effective vaccine.

METHODS

In this study, 428 adult recipients of various compositions of the norovirus vaccine candidate, HIL-214, were followed for 5 years, to assess immune responses to its virus-like particle antigens, GI.1 and GII.4c. Serum antibodies and peripheral-blood antibody-secreting cells (ASCs) were measured. This report focuses on the single-dose 15/50 (µg GI.1/GII.4c) composition, which had been selected for further clinical development.

RESULTS

For single-dose 15/50 recipients (N = 105), GI.1-specific and GII.4c-specific histoblood-group antigen-blocking (HBGA) antibodies appeared to have persisted to 5 years, waning from a peak at 4 to 8 weeks, and plateauing above baseline after 3 years. From 3 to 5 years, GI.1-specific GMTs ranged between 53 (95%CI, 40-71) and 60 (95%CI, 46-77; N = 69-97) and were approximately 2-fold above the baseline GMT (24 (95%CI, 20-28); N = 105). GII.4c-specific GMTs ranged between 103 (95%CI, 77-138) and 114 (95%CI, 86-152; N = 70-97) and were above baseline, but by less than 2-fold (70 (95%CI, 53-92); N = 105). Similar kinetics were observed for pan-Ig titers and ASCs in a subset. Similar kinetics were also observed for HBGA and pan-Ig titers in recipients of other 15/50 dosages.

CONCLUSIONS

Immune responses to HIL-214 in adults appear to persist for five years.

摘要

背景

有效的疫苗可应对由诺如病毒肠胃炎造成的重大全球经济和健康负担。

方法

在本研究中，对428名接种了不同成分的诺如病毒候选疫苗HIL-214的成年人进行了为期5年的跟踪，以评估其对病毒样颗粒抗原GI.1和GII.4c的免疫反应。检测了血清抗体和外周血抗体分泌细胞（ASC）。本报告重点关注已被选定用于进一步临床开发的单剂量15/50（微克GI.1/GII.4c）成分。

结果

对于单剂量15/50的接种者（N = 105），GI.1特异性和GII.4c特异性组织血型抗原阻断（HBGA）抗体似乎持续了5年，从4至8周的峰值下降，3年后稳定在基线以上。在3至5年期间，GI.1特异性几何平均滴度（GMT）在53（95%置信区间，40 - 71）至60（95%置信区间，46 - 77；N = 69 - 97）之间，约为基线GMT（24（95%置信区间，20 - 28）；N = 105）的2倍。GII.4c特异性GMT在103（95%置信区间，77 - 138）至114（95%置信区间，86 - 152；N = 70 - 97）之间，高于基线，但不到2倍（70（95%置信区间，53 - 92）；N = 105）。在一个亚组中，针对泛免疫球蛋白滴度和ASC也观察到了类似的动力学。在其他15/50剂量的接种者中，针对HBGA和泛免疫球蛋白滴度也观察到了类似的动力学。