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Healthy adults aged 18+ were randomised 3:1 to VLA1553 or placebo, and participants were followed for 180 days. Primary immunogenicity assessed seroprotective neutralising antibodies at day 28 using µPRNT50 criteria, while safety included all vaccinated individuals. The vaccine showed strong seroprotection, and an overall adverse event profile comparable to licensed vaccines, with few serious events judged related to treatment.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/safety-and-immunogenicity-of-a-single-shot-live-attenuated-chikungunya-vaccine-phase-3-trial/373417/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/safety-and-immunogenicity-of-a-single-shot-live-attenuated-chikungunya-vaccine-phase-3-trial/373417.png","ImageObject",300,407,{"name":92,"@type":93},"Ivy","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is VLA1553 and what does the study evaluate?","Question",{"text":112,"@type":113},"VLA1553 is a live-attenuated chikungunya vaccine candidate. The study evaluates its safety and immunogenicity after a single vaccination.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was immunogenicity measured in the trial?",{"text":117,"@type":113},"Immunogenicity was assessed by neutralising antibody levels at day 28 using a micro plaque reduction neutralisation test (µPRNT) with a µPRNT50 titre threshold.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the key safety outcomes reported?",{"text":121,"@type":113},"VLA1553 was generally safe with an adverse event profile similar to other licensed vaccines. Serious adverse events occurred in 46 (1·5%) of 3082 participants exposed to VLA1553 and eight (0·8%) of 1033 in the placebo arm, with only two considered related to treatment.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},373417,1790361180,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":52,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","Articles  \nLancet 2023; 401: 2138–47  \nPublished Online June 12, 2023  \n[https://doi.org/10.1016/](https://doi.org/10.1016/)[ ](https://doi.org/10.1016/)[S0140-6736](S0140-6736)([23](23))[00641-4](00641-4)[ ](00641-4)See Comment page 2090 Valneva Austria, Vienna, Austria  \n(M Schneider PhD, M Narciso-Abraham MSc, S Hadl MSc, R McMahon PhD, SToepfer PhD, U Fuchs MSc, R Hochreiter PhD, A Bitzer PhD, K Kosulin PhD, R Mader PhD, K Dubischar MSc, O Zoihsl MSc,  \nJ-CJaramillo MD, S Eder-Lingelbach MSc,  \nV Buerger MSc, NWressnigg PhD); Assign Data Management and Biostatistics, Innsbruck, Austria  \n(J Larcher-Senn PhD)  \nCorrespondence to: Dr Martina Schneider, Valneva Austria, 1030 Vienna, Austria  \nmartina.schneider@valneva.  \ncom  \nSafety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial  \nMartina Schneider, Marivic Narciso-Abraham, Sandra Hadl, Robert McMahon, Sebastian Toepfer, Ulrike Fuchs, Romana Hochreiter,  \nAnnegret Bitzer, Karin Kosulin, Julian Larcher-Senn, Robert Mader, Katrin Dubischar, Oliver Zoihsl, Juan-Carlos Jaramillo, Susanne Eder-Lingelbach, Vera Buerger, Nina Wressnigg  \nSummary  \nBackground VLA1553 is a live-attenuated vaccine candidate for active immunisation and prevention of disease caused by chikungunya virus. We report safety and immunogenicity data up to day 180 after vaccination with VLA1553 .  \nMethods This double-blind, multicentre, randomised, phase 3 trial was done in 43 professional vaccine trial sites in the USA. Eligible participants were healthy volunteers aged 18 years and older. Patients were excluded if they had history of chikungunya virus infection or immune-mediated or chronic arthritis or arthralgia, known or suspected defect of the immune system, any inactivated vaccine received within 2 weeks before vaccination with VLA1553, or any live vaccine received within 4 weeks before vaccination with VLA1553 . Participants were randomised (3:1) to receive VLA1553 or placebo. The primary endpoint was the proportion of baseline negative participants with aseroprotective chikungunya virus antibody level defined as 50% plaque reduction in a micro plaque reduction neutralisation test (µPRNT) with a µPRNT50 titre ofat least 150, 28 days after vaccination. The safety analysis included all individuals who received vaccination. Immunogenicity analyses were done in a subset of participants at 12 pre-selected study sites. These participants were required to have no major protocol deviations to be included in the per-protocol population for immunogenicity analyses. This trial is [registered at ClinicalTrials.gov](registered at ClinicalTrials.gov), NCT04546724.  \nFindings Between Sept 17, 2020 and April 10, 2021, 6100 people were screened for eligibility. 1972 people were excluded and 4128 participants were enrolled and randomised (3093 to VLA1553 and 1035 to placebo) . 358 participants in the VLA1553 group and 133 participants in the placebo group discontinued before trial end. The per-protocol population for immunogenicity analysis comprised 362 participants (266 in the VLA1553 group and 96 in the placebo group) . After a single vaccination, VLA1553 induced seroprotective chikungunya virus neutralising antibody levels in 263 (98·9%) of 266 participants in the VLA1553 group (95% CI 96·7–99·8; p\u003C0·0001) 28 days post-vaccination, independent of age. VLA1553 was generally safe with an adverse event profile similar to other licensed vaccines and equally well tolerated in younger and older adults. Serious adverse events were reported in 46 (1·5%) of 3082 participants exposed to VLA1553 and eight (0·8%) of 1033 participants in the placebo arm. Only two serious adverse events were considered related to VLA1553 treatment (one mild myalgia and one syndrome of inappropriate antidiuretic hormone secretion). Both participants recovered fully.  \nInterpretation The strong immune response and the generation of seroprotective t","cbCaig1vdhY3FOAS","https://ap.wps.com/l/cbCaig1vdhY3FOAS","pdf",1056344,"English","# Summary\n## Background\n## Methods\n## Findings\n## Interpretation\n## Funding\n# Introduction\n## Disease burden and unmet need\n## Vaccine candidate overview","[{\"question\":\"What is VLA1553 and what does the study evaluate?\",\"answer\":\"VLA1553 is a live-attenuated chikungunya vaccine candidate. The study evaluates its safety and immunogenicity after a single vaccination.\"},{\"question\":\"How was immunogenicity measured in the trial?\",\"answer\":\"Immunogenicity was assessed by neutralising antibody levels at day 28 using a micro plaque reduction neutralisation test (µPRNT) with a µPRNT50 titre threshold.\"},{\"question\":\"What were the key safety outcomes reported?\",\"answer\":\"VLA1553 was generally safe with an adverse event profile similar to other licensed vaccines. Serious adverse events occurred in 46 (1·5%) of 3082 participants exposed to VLA1553 and eight (0·8%) of 1033 in the placebo arm, with only two considered related to treatment.\"}]","Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine - phase 3 trial | PDF",1790199549,25]