一项2/3期试验，旨在研究单价奥密克戎JN.1适配的BNT162b2新冠疫苗在18岁及以上成年人中的安全性和免疫原性。

A phase 2/3 trial to investigate the safety and immunogenicity of monovalent Omicron JN.1-adapted BNT162b2 COVID-19 vaccine in adults ≥18 years old.

作者信息

Diya Oyeniyi, Gayed Juleen, Lowry Francine S, Ma Hua, Bangad Vishva, Mensa Federico, Zou Jing, Xie Xuping, Hu Yanping, Cutler Mark, Belanger Todd, Cooper David, Xu Xia, Koury Kenneth, Türeci Özlem, Şahin Uǧur, Swanson Kena A, Modjarrad Kayvon, Anderson Annaliesa S, Gurtman Alejandra, Kitchin Nicholas

机构信息

Vaccine Research and Development, Pfizer Ltd, Marlow, UK.

出版信息

Vaccine. 2025 Apr 11;52:126869. doi: 10.1016/j.vaccine.2025.126869. Epub 2025 Feb 24.

DOI:10.1016/j.vaccine.2025.126869

PMID:39999538

Abstract

BACKGROUND

COVID-19 remains a substantial burden in vulnerable populations, including older adults and immunocompromised individuals. It was recommended that 2024-2025 COVID-19 vaccine formulations should target a monovalent JN.1 lineage. Here we provide preliminary data on the safety, tolerability, and immunogenicity of a monovalent Omicron JN.1-adapted BNT162b2 vaccine.

METHODS

Fifty-three healthy adults ≥18 years old (18-55 years, n = 27; >55 years, n = 26) were vaccinated with Omicron JN.1-adapted BNT162b2. Primary safety endpoints were local reactions and systemic events through 7 days, adverse events (AEs) through 1 month, and serious AEs through 6 months; safety data through 1 month are presented here. Serum 50 % neutralizing titers against Omicron JN.1, KP.2, and KP.3, as well as XBB.1.5 were measured at baseline and 1 month after vaccination. Immunogenicity was also compared to a group who received monovalent XBB.1.5-adapted BNT162b2 in a previous substudy of this trial matched by age and baseline SARS-CoV-2 infection status to current substudy participants.

RESULTS

There were no new safety signals; local reactions and systemic events through 7 days of vaccination were generally mild to moderate in severity, and AEs were infrequent. One month after vaccination, JN.1-adapted BNT162b2 induced neutralizing titers against Omicron JN.1, KP.2, and KP.3 that were higher than those induced by XBB.1.5-adapted BNT162b2. In the JN.1-adapted BNT162b2 group, GMTs were generally similar for the 18-55- and >55-year-old age groups.

CONCLUSION

Collectively, these safety and immunogenicity data support administration of JN.1 lineage-adapted vaccines for the 2024-2025 season.

CLINICALTRIALS

gov Identifier: NCT05997290.

摘要

背景

新冠病毒病（COVID-19）在包括老年人和免疫功能低下个体在内的脆弱人群中仍然是一个沉重负担。建议2024 - 2025年的COVID-19疫苗配方应以单价JN.1谱系为目标。在此，我们提供了一种单价奥密克戎JN.1适配的BNT162b2疫苗的安全性、耐受性和免疫原性的初步数据。

方法

53名年龄≥18岁的健康成年人（18 - 55岁，n = 27；>55岁，n = 26）接种了奥密克戎JN.1适配的BNT162b2疫苗。主要安全性终点为7天内的局部反应和全身反应、1个月内的不良事件（AE）以及6个月内的严重AE；此处展示1个月内的安全性数据。在基线和接种疫苗1个月后测量针对奥密克戎JN.1、KP.2和KP.3以及XBB.1.5的血清50%中和滴度。免疫原性也与在该试验先前的一项子研究中接受单价XBB.1.5适配的BNT162b2的一组进行了比较，该组在年龄和基线严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染状态方面与当前子研究参与者相匹配。

结果

未发现新的安全信号；接种疫苗7天内的局部反应和全身反应一般严重程度为轻至中度，不良事件不常见。接种疫苗1个月后，JN.1适配的BNT162b2诱导产生的针对奥密克戎JN.1、KP.2和KP.3的中和滴度高于XBB.1.5适配的BNT162b2诱导产生的中和滴度。在JN.1适配的BNT162b2组中，18 - 55岁和>55岁年龄组的几何平均滴度（GMT）总体相似。