{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T20:34:41Z","timestamp":1788381281669,"version":"build-2803163510"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2022,10,19]],"date-time":"2022-10-19T00:00:00Z","timestamp":1666137600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Janssen Vaccines & Prevention"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,12,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Respiratory syncytial virus (RSV) remains a leading cause of pediatric morbidity, with no approved vaccine. We assessed the safety and immunogenicity of the Ad26.RSV.preF vaccine candidate in adults and children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this randomized, double-blind, phase 1\/2a, placebo-controlled study, 12 adults (18\u201350 years) and 36 RSV-seropositive children (12\u201324 months) were randomized 2:1 to Ad26.RSV.preF (1 \u00d7 1011 viral particles [vp] for adults, 5 \u00d7 1010 vp for children) or placebo, at day 1 and 29, with 6-month immunogenicity and 1-year safety follow-up. Respiratory syncytial virus infection was an exploratory outcome in children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In adults, solicited adverse events (AEs) were generally mild to moderate, with no serious AEs. In children, no vaccination-related serious AEs were reported; fever was reported in 14 (58.3%) Ad26.RSV.preF recipients. Baseline pediatric geometric mean titers for RSV A2 neutralization increased from 121 (95% confidence interval [CI], 76\u2013191) to 1608 (95% CI, 730\u20133544) at day 29, and 2235 (95% CI, 1586\u20133150) at day 57, remaining elevated over 7 months. Respiratory syncytial virus infection was confirmed in fewer children receiving Ad26.RSV.preF (1, 4.2%) than placebo (5, 41.7%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ad26.RSV.preF demonstrated immunogenicity in healthy adults and toddlers, with no safety concerns raised. Evaluations in RSV-seronegative children are underway.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiac407","type":"journal-article","created":{"date-parts":[[2022,10,19]],"date-time":"2022-10-19T06:57:30Z","timestamp":1666162650000},"page":"71-82","source":"Crossref","is-referenced-by-count":40,"title":["Phase 1\/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18\u201350 Years and RSV-Seropositive Children 12\u201324 Months"],"prefix":"10.1093","volume":"227","author":[{"given":"Arabella S V","family":"Stuart","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, University of Oxford , Oxford , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miia","family":"Virta","sequence":"additional","affiliation":[{"name":"Tampere University , Tampere , Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristi","family":"Williams","sequence":"additional","affiliation":[{"name":"Janssen Vaccines & Prevention BV , Leiden , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilkka","family":"Seppa","sequence":"additional","affiliation":[{"name":"Tampere University , Tampere , Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robyn","family":"Hartvickson","sequence":"additional","affiliation":[{"name":"Axtell Clinic , Newton, Kansas , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Greenland","sequence":"additional","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, University of Oxford , Oxford , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmund","family":"Omoruyi","sequence":"additional","affiliation":[{"name":"Janssen Infectious Diseases , Beerse , 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