{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T12:38:45Z","timestamp":1792067925446,"version":"4.4.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T00:00:00Z","timestamp":1773014400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002066","name":"GSK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002066","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>A vaccine that prevents Staphylococcus aureus skin and soft tissue infections (SA-SSTIs) would have a major impact on public health.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A 2-part randomized study began with a phase 1, first-in-human, dose escalation that tested the safety of the 5-antigen S. aureus vaccine (SA5Ag), half or full antigen doses, unadjuvanted or with AS01E adjuvant, in 32 healthy volunteers aged 18\u201350 years. In the phase 2, proof-of-principle part, 194 participants aged 18\u201364 years with recent SA-SSTI were administered 2 full doses of AS01E-adjuvanted SA5Ag (SA5Ag-Adj) or placebo, 2 months apart, and followed for 12 months. Vaccine safety (primary objective), vaccine efficacy (VE; secondary\/tertiary objectives), and immunogenicity (tertiary objectives) were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Following a positive safety evaluation in phase 1, participants were enrolled into phase 2 until predefined futility criteria were met at the interim efficacy analysis. Twelve months post-dose 2, SA5Ag-Adj showed no efficacy in preventing recurrent SA-SSTIs (VE, \u221238.1%; 95% confidence interval, \u2212245.8 to 40.9), despite inducing robust functional immune responses against 3 (S. aureus capsular polysaccharide types 5 and 8 [CP5 and CP8], alpha-hemolysin [Hla]) of the 5 vaccine antigens. Solicited local adverse events (AEs) were more frequent in the SA5Ag-Adj group versus the placebo group but were mostly mild or moderate in intensity. Frequencies of medically attended AEs and serious AEs were similar across groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In participants with recent history of SA-SSTI, SA5Ag-Adj vaccine had an acceptable safety profile and induced robust functional immune responses against CP5, CP8, and Hla antigens but did not reduce the rate of recurrent SA-SSTIs at 12 months from last dose.<\/jats:p>\n                    <jats:p>Clinical Trial Registration. NCT04420221.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag162","type":"journal-article","created":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T12:40:49Z","timestamp":1772800849000},"page":"e569-e577","source":"Crossref","is-referenced-by-count":2,"title":["Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted\n                    <i>Staphylococcus aureus<\/i>\n                    Vaccine in Adults With Recent Skin and Soft Tissue Infections: An Observer-Blind, Randomized, Placebo-Controlled, Multinational Phase 1\/2 Trial"],"prefix":"10.1093","volume":"83","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9838-6471","authenticated-orcid":false,"given":"Eugene","family":"Athan","sequence":"first","affiliation":[{"name":"Public Health Unit, Barwon Health, Deakin University , Geelong 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