{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:26:19Z","timestamp":1787009179737,"version":"build-2736575974"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2024,10,14]],"date-time":"2024-10-14T00:00:00Z","timestamp":1728864000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Coalition for Epidemic Preparedness Innovation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Chikungunya disease, caused by chikungunya virus (CHIKV), is associated with substantial morbidity, including debilitating CHIKV-related arthralgia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Three clinical trials of a CHIKV vaccine (VLA1553, IXCHIQ\u00ae) were conducted in the USA: a Phase 1 dose-finding trial, a pivotal Phase 3 trial and a Phase 3 lot-to-lot consistency trial. Participants were healthy adults (\u226518\u00a0years) and received a single intramuscular dose of VLA1553 (3520 participants) or placebo (1033 participants). Solicited injection site and systemic adverse events (AEs) (10\u201314\u00a0days post-vaccination), unsolicited AEs (28 and 180\u00a0days post-vaccination), AEs of special interest (AESIs) (28\u00a0days post-vaccination), medically attended AEs (MAAEs), serious AEs (SAEs) (180\u00a0days post-vaccination) and pregnancies were evaluated. Safety data were pooled, and analyses were descriptive.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 63.7% of participants receiving VLA1553 experienced AEs (44.7% for placebo) that were generally mild. Solicited injection-site AEs, solicited systemic AEs and unsolicited (Day 29) AEs were reported by 15.5, 50.9 and\u00a022.7% of participants who received VLA1553 and 11.1, 26.9 and 13.4% who received placebo. Arthralgia was reported by 16.7% of participants who received VLA1553 and 4.8% of participants who received placebo; none required medical attention. MAAEs, AESIs and SAEs were reported by 12.4, 0.3 and 1.5% of participants who received VLA1553 and 11.3, 0.1 and 0.8% of participants who received placebo. Protocol-defined AESIs were mild and short-lived, and two VLA1553-related SAEs resolved without sequelae. There were no clinically important differences in AE incidence based on age or medical history and no VLA1553-related adverse pregnancy outcomes. There were three deaths (two in the VLA1553 group and one in the placebo group); none was vaccine-related.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A single dose of VLA1553 presented with an excellent local tolerability profile and overall safety in line with that expected for a live-attenuated vaccine. The safety profile was comparable in participants aged 18\u201364\u00a0years and\u2009\u226565\u00a0years.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jtm\/taae133","type":"journal-article","created":{"date-parts":[[2024,10,11]],"date-time":"2024-10-11T07:20:07Z","timestamp":1728631207000},"source":"Crossref","is-referenced-by-count":17,"title":["Pooled safety evaluation for a new single-shot live-attenuated chikungunya vaccine"],"prefix":"10.1093","volume":"31","author":[{"given":"Gabriele","family":"Maurer","sequence":"first","affiliation":[{"name":"Valneva Austria GmbH , Campus Vienna Biocenter 3, 1030 Vienna,","place":["Austria"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vera","family":"Buerger","sequence":"additional","affiliation":[{"name":"Valneva Austria GmbH , Campus Vienna Biocenter 3, 1030 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