{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:01:44Z","timestamp":1792069304613,"version":"4.4.0"},"reference-count":76,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T00:00:00Z","timestamp":1725926400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Coalition for Epidemic Preparedness Innovation and EU Horizon 2020","award":["VLA1553"],"award-info":[{"award-number":["VLA1553"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,10,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Over the past 20\u00a0years, over 5 million cases of chikungunya, a mosquito-transmitted viral disease, have been reported in over 110 countries. Until recently, preventative strategies for chikungunya were largely ineffective, relying on vector control and individual avoidance of mosquito bites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This review outlines the preclinical and clinical efficacy and safety data that led to the approval of VLA1553 (IXCHIQ\u00ae), a live-attenuated vaccine against chikungunya disease. It also describes the innovative development pathway of VLA1553, based on an immunological surrogate of protection, and discusses ongoing and future post-licensure studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In mice and non-human primate models, VLA1553 elicited high titres of neutralizing antibodies, conferred protection against wild-type chikungunya virus challenge and raised no safety concerns. A Phase 1 clinical trial of VLA1553 demonstrated 100% seroconversion among 120 healthy participants, with sustained neutralizing antibody titres after 12\u00a0months. These results and determination of a surrogate marker of protection led to advancement of VLA1553 directly into Phase 3 clinical development, as agreed with the US Food and Drug Administration (FDA) and the European Medicines Agency. The pivotal Phase 3 trial met its primary immunogenicity endpoint, achieving seroprotective levels based on immuno-bridging in baseline seronegative participants 28\u00a0days post-vaccination. These findings enabled submission of a Biologics Licence Application to the FDA for accelerated approval of VLA1553 in the US for adults aged \u226518\u00a0years. Ongoing and planned studies will confirm the clinical efficacy\/effectiveness and safety of VLA1553 in adults and younger individuals, and will generate data in chikungunya endemic countries that have the highest unmet need.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>VLA1553 is the first vaccine approved for the prevention of chikungunya disease in adults, following accelerated development based on a serological surrogate marker of protection. VLA1553 adds to strategies to reduce the spread and burden of chikungunya in endemic populations and travellers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jtm\/taae123","type":"journal-article","created":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T15:00:00Z","timestamp":1725980400000},"source":"Crossref","is-referenced-by-count":46,"title":["From bench to clinic: the development of VLA1553\/IXCHIQ, a live-attenuated chikungunya vaccine"],"prefix":"10.1093","volume":"31","author":[{"given":"Lin H","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases and Travel Medicine, Mount Auburn Hospital , 330 Mt Auburn St, Cambridge, MA 02138,","place":["USA"]},{"name":"Faculty of Medicine, Harvard Medical School , 25 Shattuck St, Boston, MA 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