Maurer Gabriele, Buerger Vera, Larcher-Senn Julian, Erlsbacher Florian, Meyer Stéphanie, Eder-Lingelbach Susanne, Jaramillo Juan Carlos
Valneva Austria GmbH, 1030 Vienna, Austria.
Assign Data Management and Statistics GmbH, 6020 Innsbruck, Austria.
Vaccines (Basel). 2025 May 28;13(6):576. doi: 10.3390/vaccines13060576.
This overview provides a comprehensive safety evaluation of the approved live-attenuated vaccine VLA1553 (IXCHIQ) for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in clinical trials. : Protocol-defined solicited systemic events (i.e., fever, arthralgia, myalgia, fatigue, and headache) and other unsolicited arthralgia-related events were evaluated. Additionally, during a regulatory review, a broader definition of adverse events of special interest (broad-definition AESIs) (fever and ≥1 AESI symptom within 30 days post-vaccination) was evaluated post hoc. : The most frequently reported solicited systemic events post-VLA1553 included fever (13.5%), arthralgia (17.2%), myalgia (23.9%), fatigue (28.5%), and headache (31.6%), with very few prolonged symptoms. The incidence of unsolicited arthralgia-related events (arthritis, osteoarthritis, musculoskeletal stiffness, joint stiffness, and joint swelling) was comparable between VLA1553 and placebo groups. Broad-definition AESIs were observed in 11.7% (361/3082) participants (VLA1553) and 0.6% (6/1033) participants (placebo), with a duration of 1-182 days (median: 4 days; prolonged broad-definition AESI [≥1 symptom lasting ≥ 30 days] occurred in 0.5% of participants) (VLA1553) and 4-27 days (median: 8 days) (placebo). Most symptoms contributing to broad-definition AESIs were solicited. In the VLA1553 group, the most common of these symptoms, in addition to fever, were headache (9.1% of participants), fatigue (8.6%), myalgia (7.0%), and arthralgia (5.2%). There were few severe cases (1.6% of participants in the VLA1553 group). : In clinical trials, VLA1553 showed an acceptable safety profile that was consistent with other live-attenuated vaccines. The incidence of broad-definition AESIs was mainly limited to the immediate post-vaccination period, and broad-definition AESI symptoms were mostly solicited systemic adverse events.
本综述对已获批的减毒活疫苗VLA1553（IXCHIQ）进行了全面的安全性评估，该疫苗用于在临床试验中进行主动免疫，以预防基孔肯雅病毒（CHIKV）引起的疾病。对方案定义的预期全身性事件（即发热、关节痛、肌痛、疲劳和头痛）以及其他非预期的关节痛相关事件进行了评估。此外，在一次监管审查期间，事后评估了特殊关注不良事件的更宽泛定义（宽泛定义的AESI）（接种疫苗后30天内发热和≥1种AESI症状）。VLA1553接种后最常报告的预期全身性事件包括发热（13.5%）、关节痛（17.2%）、肌痛（23.9%）、疲劳（28.5%）和头痛（31.6%），很少有症状持续时间延长的情况。VLA1553组和安慰剂组中非预期的关节痛相关事件（关节炎、骨关节炎、肌肉骨骼僵硬、关节僵硬和关节肿胀）的发生率相当。在11.7%（361/3082）的参与者（VLA1553组）和0.6%（6/1033）的参与者（安慰剂组）中观察到宽泛定义的AESI，持续时间为1 - 182天（中位数：4天；VLA1553组中0.5%的参与者出现持续时间延长的宽泛定义AESI[≥1种症状持续≥30天]），安慰剂组为4 - 27天（中位数：8天）。导致宽泛定义AESI的大多数症状是预期的。在VLA1553组中，除发热外，这些症状中最常见的是头痛（9.1%的参与者）、疲劳（8.6%）、肌痛（7.0%）和关节痛（5.2%）。严重病例很少（VLA1553组中1.6%的参与者）。在临床试验中，VLA1553显示出可接受的安全性概况，与其他减毒活疫苗一致。宽泛定义的AESI发生率主要局限于接种疫苗后的即刻期间，且宽泛定义的AESI症状大多是预期的全身性不良事件。
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