{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T01:54:53Z","timestamp":1792806893962,"version":"4.5.0"},"reference-count":61,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T00:00:00Z","timestamp":1748390400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Valneva Austria, GmbH","award":["Valneva 0002"],"award-info":[{"award-number":["Valneva 0002"]}]},{"name":"Coalition for Epidemic Preparedness Innovation (CEPI)","award":["Valneva 0002"],"award-info":[{"award-number":["Valneva 0002"]}],"id":[{"id":"https:\/\/ror.org\/02j9wvt50","id-type":"ROR","asserted-by":"crossref"}]},{"name":"EU Horizon 2020","award":["Valneva 0002"],"award-info":[{"award-number":["Valneva 0002"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: This overview provides a comprehensive safety evaluation of the approved live-attenuated vaccine VLA1553 (IXCHIQ\u00ae) for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in clinical trials. Methods: 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 \u22651 AESI symptom within 30 days post-vaccination) was evaluated post hoc. Results: 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\u2013182 days (median: 4 days; prolonged broad-definition AESI [\u22651 symptom lasting \u2265 30 days] occurred in 0.5% of participants) (VLA1553) and 4\u201327 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). Conclusions: 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.<\/jats:p>","DOI":"10.3390\/vaccines13060576","type":"journal-article","created":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T08:12:47Z","timestamp":1748419967000},"page":"576","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Comprehensive Assessment of Reactogenicity and Safety of the Live-Attenuated Chikungunya Vaccine (IXCHIQ\u00ae)"],"prefix":"10.3390","volume":"13","author":[{"given":"Gabriele","family":"Maurer","sequence":"first","affiliation":[{"name":"Valneva Austria GmbH, 1030 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9884-1006","authenticated-orcid":false,"given":"Vera","family":"Buerger","sequence":"additional","affiliation":[{"name":"Valneva Austria GmbH, 1030 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3169-1900","authenticated-orcid":false,"given":"Julian","family":"Larcher-Senn","sequence":"additional","affiliation":[{"name":"Assign Data Management and Statistics GmbH, 6020 Innsbruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"Erlsbacher","sequence":"additional","affiliation":[{"name":"Assign Data Management and Statistics GmbH, 6020 Innsbruck, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phanie","family":"Meyer","sequence":"additional","affiliation":[{"name":"Valneva SE, 69002 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Eder-Lingelbach","sequence":"additional","affiliation":[{"name":"Valneva Austria GmbH, 1030 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"Jaramillo","sequence":"additional","affiliation":[{"name":"Valneva Austria GmbH, 1030 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,5,28]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1056\/NEJMc1505501","article-title":"Chikungunya virus infections","volume":"373","author":"Simon","year":"2015","journal-title":"N. 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