{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T22:08:49Z","timestamp":1787868529555,"version":"build-2784847793"},"reference-count":26,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T00:00:00Z","timestamp":1678233600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"NPO Petrovax Pharm LLC"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"\n Background<\/jats:title>\n \n To determine the immunogenicity, efficacy, reactogenicity, and safety of a single dose of recombinant adenovirus type-5 vectored COVID-19 vaccine (Ad5-nCoV, 5 \u00d7 10\n 10<\/jats:sup>\n viral particles per 0.5 mL dose), we conducted a single-dose, randomised, double-blind, placebo-controlled, parallel group (3:1 Ad5-nCoV:placebo), phase 3 trial (Prometheus).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n From 11-September-2020 to 05-May-2021, across six sites in the Russian Federation, 496 participants were injected with either placebo or Ad5-nCoV expressing the full-length spike (S) protein from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Seroconversion (the primary endpoint) rates of 78.5% (95% CI: 73.9; 82.6) against receptor binding domain (RBD), 90.6% (95% CI: 87.2; 93.4) against S protein and 59.0% (95% CI: 53.3; 64.6) seroconversion of neutralising antibodies against SARS-CoV-2 at 28 days post-vaccination were observed. Geometric mean titres (GMTs) were also elevated for antibodies against the RBD (405 [95% CI: 366; 449]) and S protein (677 [95% CI: 608; 753]) compared to the GMT of neutralising antibodies against SARS-CoV-2 (16.7 [95% CI: 15.3; 18.3]). Using an IFN-\u03b3 ELISpot assay after stimulating the cells with recombinant S protein ectodomain we showed that the Ad5-nCoV vaccine induced the most robust cellular immune response on Days 14 and 28. Up to Day 28, the primary and all secondary endpoints of the Ad5-nCoV vaccine were statistically significant compared with the placebo (\u0440<0.001). Systemic reactions were reported in 113 of 496 (22.8%) participants (Ad5-nCoV, 26.9%; Placebo, 10.5%), and local reactions were reported in 108 (21.8%) participants (Ad5-nCoV, 28.5%; Placebo, 1.6%). These were generally mild and resolved within 7 days after vaccination. Of the six serious adverse events reported, none of the events were vaccine related. There were no deaths or premature withdrawals.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n A single-dose of Ad5-nCoV vaccine induced a marked specific humoral and cellular immune response with a favourable safety profile.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n Trial registration:<\/jats:bold>\n ClinicalTrials.gov:\n NCT04540419<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0278878","type":"journal-article","created":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T13:42:34Z","timestamp":1678282954000},"page":"e0278878","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":6,"title":["Immunogenicity and safety of a recombinant adenovirus type-5 COVID-19 vaccine in adults: Data from a randomised, double-blind, placebo-controlled, single-dose, phase 3 trial in Russia"],"prefix":"10.1371","volume":"18","author":[{"given":"Dmitry","family":"Lioznov","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1769-0645","authenticated-orcid":true,"given":"Irina","family":"Amosova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Savely A.","family":"Sheetikov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9568-2109","authenticated-orcid":true,"given":"Ksenia V.","family":"Zornikova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yana","family":"Serdyuk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7129-6062","authenticated-orcid":true,"given":"Grigory A.","family":"Efimov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikhail","family":"Tsyferov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikhail","family":"Khmelevskii","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrei","family":"Afanasiev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9111-3144","authenticated-orcid":true,"given":"Nadezhda","family":"Khomyakova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitry","family":"Zubkov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anton","family":"Tikhonov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Barreto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5630-755X","authenticated-orcid":true,"given":"Vitalina","family":"Dzutseva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,3,8]]},"reference":[{"issue":"1","key":"pone.0278878.ref001","first-page":"E64","article-title":"The 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Tan","year":"2021","journal-title":"News: BBC"},{"issue":"10275","key":"pone.0278878.ref023","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1016\/S0140-6736(21)00191-4","article-title":"Sputnik V COVID-19 vaccine candidate appears safe and effective","volume":"397","author":"I Jones","year":"2021","journal-title":"Lancet"},{"issue":"19","key":"pone.0278878.ref024","doi-asserted-by":"crossref","first-page":"1824","DOI":"10.1056\/NEJMoa2034201","article-title":"Interim Results of a Phase 1\u20132a Trial of Ad26.COV2.S Covid-19 Vaccine","volume":"384","author":"J Sadoff","year":"2021","journal-title":"New Engl J Med"},{"issue":"8","key":"pone.0278878.ref025","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1038\/s41591-020-0965-6","article-title":"Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections","volume":"26","author":"QX Long","year":"2020","journal-title":"Nat Med"},{"key":"pone.0278878.ref026","article-title":"Oxford\/AstraZeneca jab fails to prevent mild and moderate Covid from S African strain, study shows","author":"DP Mancini","year":"2021","journal-title":"Financial Times"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0278878","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T13:42:55Z","timestamp":1678282975000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0278878"}},"subtitle":[],"editor":[{"given":"Nagendra R.","family":"Hegde","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2023,3,8]]},"references-count":26,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,3,8]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0278878","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2022.03.01.22271507","asserted-by":"object"}]},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,8]]}}}