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      Antibody responses to the BNT162b2 mRNA vaccine in individuals previously infected with SARS-CoV-2

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          Abstract

          In a cohort of BNT162b2 (Pfizer–BioNTech) mRNA vaccine recipients ( n = 1,090), we observed that spike-specific IgG antibody levels and ACE2 antibody binding inhibition responses elicited by a single vaccine dose in individuals with prior SARS-CoV-2 infection ( n = 35) were similar to those seen after two doses of vaccine in individuals without prior infection ( n = 228). Post-vaccine symptoms were more prominent for those with prior infection after the first dose, but symptomology was similar between groups after the second dose.

          Abstract

          Virus-specific antibody levels after a single dose of the BNT162b2 vaccine in individuals previously infected with SARS-CoV-2 are similar to levels after two doses of the vaccine in infection-naive individuals.

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          Most cited references13

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

            Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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              The REDCap consortium: Building an international community of software platform partners

              The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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                Author and article information

                Contributors
                jonathan.braun2@cshs.org
                susan.cheng@cshs.org
                kimia.sobhani@cshs.org
                Journal
                Nat Med
                Nat Med
                Nature Medicine
                Nature Publishing Group US (New York )
                1078-8956
                1546-170X
                1 April 2021
                1 April 2021
                2021
                : 27
                : 6
                : 981-984
                Affiliations
                [1 ]GRID grid.50956.3f, ISNI 0000 0001 2152 9905, Department of Cardiology, Smidt Heart Institute, , Cedars-Sinai Medical Center, ; Los Angeles, CA USA
                [2 ]GRID grid.50956.3f, ISNI 0000 0001 2152 9905, Advanced Clinical Biosystems Institute, Department of Biomedical Sciences, , Cedars-Sinai Medical Center, ; Los Angeles, CA USA
                [3 ]GRID grid.50956.3f, ISNI 0000 0001 2152 9905, F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, ; Los Angeles, CA USA
                [4 ]GRID grid.417574.4, ISNI 0000 0004 0366 7505, Applied Research and Technology, Abbott Diagnostics, ; Abbott Park, IL USA
                [5 ]GRID grid.50956.3f, ISNI 0000 0001 2152 9905, Department of Pathology and Laboratory Medicine, , Cedars-Sinai Medical Center, ; Los Angeles, CA USA
                Author information
                http://orcid.org/0000-0001-9050-148X
                http://orcid.org/0000-0003-1646-2974
                http://orcid.org/0000-0002-4977-036X
                http://orcid.org/0000-0002-9297-3445
                Article
                1325
                10.1038/s41591-021-01325-6
                8205849
                33795870
                ba22bf22-aa8f-4dfd-9a84-d549ad375dd9
                © The Author(s) 2021

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 23 February 2021
                : 18 March 2021
                Funding
                Funded by: FundRef https://doi.org/10.13039/100000002, U.S. Department of Health & Human Services | National Institutes of Health (NIH);
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award ID: K23-HL153888
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award ID: U54-CA260591
                Award Recipient :
                Funded by: FundRef https://doi.org/10.13039/100013015, Cedars-Sinai Medical Center (Cedars-Sinai);
                Funded by: Erika J Glazer Family Foundation
                Funded by: FundRef https://doi.org/10.13039/100007028, Leona M. and Harry B. Helmsley Charitable Trust (Helmsley Charitable Trust);
                Funded by: F. Widjaja Family Foundation
                Categories
                Brief Communication
                Custom metadata
                © The Author(s), under exclusive licence to Springer Nature America, Inc. 2021

                Medicine
                viral infection,rna vaccines,sars-cov-2,antibodies
                Medicine
                viral infection, rna vaccines, sars-cov-2, antibodies

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