{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T21:44:34Z","timestamp":1788299074368,"version":"build-2803163510"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"17-18","license":[{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"curevac ag"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Wien Klin Wochenschr"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We used the RNActive\u00ae technology platform (CureVac N.V., T\u00fcbingen, Germany) to prepare CVnCoV, a\u00a0COVID-19 vaccine containing sequence-optimized mRNA coding for a\u00a0stabilized form of SARS-CoV\u20112 spike (S) protein encapsulated in lipid nanoparticles (LNP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This is an interim analysis of a\u00a0dosage escalation phase 1\u00a0study in healthy 18\u201360-year-old volunteers in Hannover, Munich and T\u00fcbingen, Germany, and Ghent, Belgium. After giving 2 intramuscular doses of CVnCoV or placebo 28\u00a0days apart we assessed solicited local and systemic adverse events (AE) for 7\u00a0days and unsolicited AEs for 28\u00a0days after each vaccination. Immunogenicity was measured as enzyme-linked immunosorbent assay (ELISA)  IgG antibodies to SARS-CoV\u20112 S\u2011protein and receptor binding domain (RBD), and SARS-CoV\u20112 neutralizing titers (MN\n                      <jats:sub>50<\/jats:sub>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In 245 volunteers who received 2 CVnCoV vaccinations (2\u202f\u03bcg,\n                      <jats:italic>n<\/jats:italic>\n                      \u202f=\u200947, 4\u202f\u03bcg,\n                      <jats:italic>n<\/jats:italic>\n                      \u202f=\u200948, 6\u202f\u03bcg,\n                      <jats:italic>n<\/jats:italic>\n                      \u202f=\u200946, 8\u202f\u03bcg,\n                      <jats:italic>n<\/jats:italic>\n                      \u202f=\u200944, 12\u202f\u03bcg,\n                      <jats:italic>n<\/jats:italic>\n                      \u202f=\u200928) or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u202f=\u200932) there were no vaccine-related serious AEs. Dosage-dependent increases in frequency and severity of solicited systemic AEs, and to a\u00a0lesser extent local AEs, were mainly mild or moderate and transient in duration. Dosage-dependent increases in IgG antibodies to S\u2011protein and RBD and MN\n                      <jats:sub>50<\/jats:sub>\n                      were evident in all groups 2 weeks after the second dose when 100% (23\/23) seroconverted to S\u2011protein or RBD, and 83% (19\/23) seroconverted for MN\n                      <jats:sub>50<\/jats:sub>\n                      in the 12\u202f\u03bcg group. Responses to 12\u202f\u03bcg were comparable to those observed in convalescent sera from known COVID-19\u00a0patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this study 2 CVnCoV doses were safe, with acceptable reactogenicity and 12\u202f\u03bcg dosages elicited levels of immune responses that overlapped those observed in convalescent sera.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00508-021-01922-y","type":"journal-article","created":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T16:02:54Z","timestamp":1628611374000},"page":"931-941","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":96,"title":["Safety and immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2"],"prefix":"10.1007","volume":"133","author":[{"given":"Peter 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N\u00a0Engl J Med. 2021; https:\/\/doi.org\/10.1056\/NEJMsr2105280.","journal-title":"N Engl J Med"}],"container-title":["Wiener klinische Wochenschrift"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00508-021-01922-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00508-021-01922-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00508-021-01922-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,15]],"date-time":"2021-09-15T07:22:42Z","timestamp":1631690562000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00508-021-01922-y"}},"subtitle":["A\u00a0phase\u00a01 randomized clinical trial"],"short-title":[],"issued":{"date-parts":[[2021,8,10]]},"references-count":32,"journal-issue":{"issue":"17-18","published-print":{"date-parts":[[2021,9]]}},"alternative-id":["1922"],"URL":"https:\/\/doi.org\/10.1007\/s00508-021-01922-y","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2020.11.09.20228551","asserted-by":"object"}]},"ISSN":["0043-5325","1613-7671"],"issn-type":[{"value":"0043-5325","type":"print"},{"value":"1613-7671","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,10]]},"assertion":[{"value":"2 July 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 July 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 August 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"P.\u00a0Mann, G.\u00a0Quintini, O.-O.\u00a0Wolz, M.\u00a0Fotin-Mleczek, L.\u00a0Walz, D.\u00a0Vahrenhorst, S.\u00a0O. Mueller, M.\u00a0Alves de Mesquita and L.\u00a0Oostvogels were employed by the study sponsor at the time of the study, O.\u00a0Sch\u00f6nborn-Kellenberger and T.\u00a0Verstraeten are paid consultants for the study sponsor. P.\u00a0Kremsner, A.\u00a0Kroidl, I.\u00a0Leroux-Roels, C.\u00a0Schindler, J.\u00a0Gabor, M.\u00a0Schunk, G.\u00a0Leroux-Roels, J.\u00a0Bosch, R.\u00a0Fendel, A.\u00a0Kreidenweiss and T.\u00a0Velavan declare that they have no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}