{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:44:44Z","timestamp":1791359084789,"version":"4.3.1"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2022,5,11]],"date-time":"2022-05-11T00:00:00Z","timestamp":1652227200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,12,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Respiratory syncytial virus (RSV) is an important cause of disease in older adults. We evaluated the safety and immunogenicity of a stabilized RSV prefusion F subunit (RSVpreF) vaccine candidate with\/without adjuvant in adults aged 65\u201385 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Primary cohort participants were equally randomized to 1 of 7 RSVpreF formulations: 60\u2005\u00b5g with either Al(OH)3 or CpG\/Al(OH)3, 120\u2005\u00b5g with either Al(OH)3 or CpG\/Al(OH)3, 240\u2005\u00b5g with either Al(OH)3 or CpG\/Al(OH)3, 240\u2005\u00b5g unadjuvanted, or placebo, administered concomitantly with high-dose seasonal inactivated influenza vaccine (SIIV). Participants in the month 0,2 cohort were randomized to RSVpreF 240\u2005\u00b5g with CpG\/Al(OH)3 or placebo, administered at months 0 and 2.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All RSVpreF vaccine candidates elicited robust and persistent serum neutralizing responses when administered alone or with SIIV. There was no notable difference in neutralizing response between the formulations, including those containing CpG. In the month 0,2 cohort, there was no booster effect of dose 2. SIIV responses were similar or slightly lower with concomitant administration of RSVpreF. Most systemic and local reactions were mild and more frequent after RSVpreF than placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>RSVpreF formulations were well tolerated and elicited robust neutralizing responses in older adults; however, CpG\/Al(OH)3 did not further enhance responses.<\/jats:p>\n                    <jats:p>Clinical Trials Registration.\u2003NCT03572062.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiac189","type":"journal-article","created":{"date-parts":[[2022,5,10]],"date-time":"2022-05-10T07:12:56Z","timestamp":1652166776000},"page":"2054-2063","source":"Crossref","is-referenced-by-count":43,"title":["A Phase 1\/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults"],"prefix":"10.1093","volume":"226","author":[{"given":"James","family":"Baber","sequence":"first","affiliation":[{"name":"Vaccine Clinical Research, Pfizer Inc , Sydney , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Arya","sequence":"additional","affiliation":[{"name":"Australian Clinical Research Network , Maroubra , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuben","family":"Moodley","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Western Australia , Perth, WA , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Jaques","sequence":"additional","affiliation":[{"name":"Vaccine Clinical Research, Pfizer Inc , Sydney , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qin","family":"Jiang","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kena A","family":"Swanson","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cooper","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohan S","family":"Maddur","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakob","family":"Loschko","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandra","family":"Gurtman","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin U","family":"Jansen","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William C","family":"Gruber","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip R","family":"Dormitzer","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beate","family":"Schmoele-Thoma","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Pharma GmbH , Berlin , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,5,11]]},"reference":[{"key":"2022121410363694600_jiac189-B1","doi-asserted-by":"crossref","first-page":"e341","DOI":"10.1542\/peds.2013-0303","article-title":"Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age","volume":"132","author":"Hall","year":"2013","journal-title":"Pediatrics"},{"key":"2022121410363694600_jiac189-B2","doi-asserted-by":"crossref","first-page":"342","DOI":"10.1093\/cid\/cit767","article-title":"Medically attended respiratory syncytial virus infections in adults aged \u2265 50 years: clinical characteristics and outcomes","volume":"58","author":"Sundaram","year":"2014","journal-title":"Clin 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