Show simple item record

dc.contributor.authorMulligan, Mark J.
dc.contributor.authorLyke, Kirsten E.
dc.contributor.authorKitchin, Nicholas
dc.contributor.authorAbsalon, Judith
dc.contributor.authorGurtman, Alejandra
dc.contributor.authorLockhart, Stephen
dc.contributor.authorNeuzil, Kathleen
dc.contributor.authorRaabe, Vanessa
dc.contributor.authorBailey, Ruth
dc.contributor.authorSwanson, Kena A.
dc.contributor.authorLi, Ping
dc.contributor.authorKoury, Kenneth
dc.contributor.authorKalina, Warren
dc.contributor.authorCooper, David
dc.contributor.authorFontes-Garfias, Camila
dc.contributor.authorShi, Pei Yong
dc.contributor.authorTüreci, Özlem
dc.contributor.authorTompkins, Kristin R.
dc.contributor.authorWalsh, Edward E.
dc.contributor.authorFrenck, Robert
dc.contributor.authorFalsey, Ann R.
dc.contributor.authorDormitzer, Philip R.
dc.contributor.authorGruber, William C.
dc.contributor.authorŞahin, Uğur
dc.contributor.authorJansen, Kathrin U.
dc.date.accessioned2020-09-01T15:23:39Z
dc.date.available2020-09-01T15:23:39Z
dc.date.issued2020-01-01
dc.identifier.urihttp://hdl.handle.net/10713/13608
dc.description10.1038/s41586-020-03098-3 is the correction to: Nature https://doi.org/10.1038/s41586-020-2639-4 Published online 12 August 2020. In the print version of this Article, some of the symbols were corrupted in Fig. 4. The HTML and PDF versions of the Article were correct, and so the original Article has not been corrected online.
dc.description.abstractIn March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. With rapidly accumulating cases and deaths reported globally2, a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG con.centrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. (ClinicalTrials.gov identifier: NCT04368728). © 2020, The Author(s)en_US
dc.description.urihttps://doi.org/10.1038/s41586-020-2639-4en_US
dc.description.urihttps://doi.org/10.1038/s41586-020-03098-3
dc.language.isoen_USen_US
dc.publisherSpringer Natureen_US
dc.relation.ispartofNatureen_US
dc.subjectBNT162b1en_US
dc.subject.meshCOVID-19 Vaccines--immunologyen_US
dc.titlePhase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adultsen_US
dc.typeArticleen_US
dc.identifier.doi10.1038/s41586-020-2639-4
dc.identifier.scopusidSCOPUS_ID:85089311448


This item appears in the following Collection(s)

Show simple item record