{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T20:34:40Z","timestamp":1788381280998,"version":"build-2803163510"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2019,7,24]],"date-time":"2019-07-24T00:00:00Z","timestamp":1563926400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"GlaxoSmithKline Biologicals SA"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,5,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Respiratory syncytial virus (RSV) disease is a major cause of infant morbidity and mortality. This Phase I, randomized, observer-blind, placebo- and active-controlled study evaluated an investigational vaccine against RSV (ChAd155-RSV) using the viral vector chimpanzee-adenovirus-155, encoding RSV fusion (F), nucleocapsid, and transcription antitermination proteins.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Healthy 18\u201345-year-old adults received ChAd155-RSV, a placebo, or an active control (Bexsero) at Days (D) 0 and 30. An escalation from a low dose (5 \u00d7 109 viral particles) to a high dose (5 \u00d7 1010 viral particles) occurred after the first 16 participants. Endpoints were solicited\/unsolicited and serious adverse events (SAEs), biochemical\/hematological parameters, cell-mediated immunogenicity by enzyme-linked immunospot, functional neutralizing antibodies, anti RSV-F immunoglobin (Ig) G, and ChAd155 neutralizing antibodies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>There were 7 participants who received the ChAd155-RSV low dose, 31 who received the ChAd155-RSV high dose, 19 who received the placebo, and 15 who received the active control. No dose-related toxicity or attributable SAEs at the 1-year follow-up were observed. The RSV-A neutralizing antibodies geometric mean titer ratios (post\/pre-immunization) following a high dose were 2.6 (D30) and 2.3 (D60). The ratio of the fold-rise (D0 to D30) in anti-F IgG over the fold-rise in RSV-A\u2013neutralizing antibodies was 1.01. At D7 after the high dose of the study vaccine, the median frequencies of circulating B-cells secreting anti-F antibodies were 133.3\/106 (IgG) and 16.7\/106 (IgA) in peripheral blood mononuclear cells (PBMCs). The median frequency of RSV-F\u2013specific interferon \u03b3\u2013secreting T-cells after a ChAd155-RSV high dose was 108.3\/106 PBMCs at D30, with no increase after the second dose.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In adults previously naturally exposed to RSV, ChAd155-RSV generated increases in specific humoral and cellular immune responses without raising significant safety concerns.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT02491463.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciz653","type":"journal-article","created":{"date-parts":[[2019,7,23]],"date-time":"2019-07-23T19:08:16Z","timestamp":1563908896000},"page":"2073-2081","source":"Crossref","is-referenced-by-count":53,"title":["First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector\u2013Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults"],"prefix":"10.1093","volume":"70","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6347-966X","authenticated-orcid":false,"given":"Paola","family":"Cicconi","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Jones","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esha","family":"Sarkar","sequence":"first","affiliation":[{"name":"Oxford Vaccine Group, Department of Paediatrics, University of Oxford, United 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Rixensart, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Janssens","sequence":"first","affiliation":[{"name":"GSK, Rixensart, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence A","family":"Fissette","sequence":"first","affiliation":[{"name":"GSK, Wavre, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Picciolato","sequence":"first","affiliation":[{"name":"GSK, Rixensart, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Leach","sequence":"first","affiliation":[{"name":"GSK, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Gonzalez-Lopez","sequence":"first","affiliation":[{"name":"GSK, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilse","family":"Dieussaert","sequence":"first","affiliation":[{"name":"GSK, Rockville, 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