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A Targeted Vaccine against COVID-19: S1-Fc Vaccine Targeting the Antigen-Presenting Cell Compartment Elicits Protection against SARS-CoV-2 Infection

By Andreas Herrmann, Junki Maruyama, Chanyu Yue, Christoph Lahtz, Heyue Zhou, Lisa Kerwin, Whenzong Guo, Yanliang Zhang, William Soo Hoo, Soonpin Yei, Sunkuk Kwon, Yanwen Fu, Sachi Johnson, Arthur Ledesma, Yiran Zhou, Yingcong Zhuang, Elena Yei, Tomasz Adamus, Slobodan Praessler, Henry Ji

Posted 30 Jun 2020
bioRxiv DOI: 10.1101/2020.06.29.178616

Vaccination efficacy is enhanced by targeting the antigen-presenting cell compartment. Here, we show that S1-Fc antigen delivery targeting the FcgammaR+ antigen-presenting cell compartment elicits anti-SARS-CoV-2 S1-antigen specific IgG production in vivo exerting biologically functional and protective activity against live virus infection, assessed in a stringent experimental virus challenge assay in vitro. The S1-domain of the SARS-CoV-2 spike protein was genetically fused to a human immunoglobulin Fc moiety, which contributes to mediate S1-Fc cellular internalization by FcgammaR+ antigen-presenting cells. Immediately upon administration intramuscularly, our novel vaccine candidate recombinant rS1-Fc homes to lymph nodes in vivo where FcgammaR+ antigen-presenting cells reside. Seroconversion is achieved as early as day 7, mounting considerably increased levels of anti-S1 IgGs in vivo. Interestingly, immunization at elevated doses with non-expiring S1-Fc encoding dsDNA favors the education of a desired antigen-specific adaptive T cell response. However, low-dose immunization, safeguarding patient safety, using recombinant rS1-Fc, elicits a considerably elevated protection amplitude against live SARS-CoV-2 infection. Our promising findings on rS1-Fc protein immunization prompted us to further develop an affordable and safe product for delivery to our communities in need for COVID-19 vaccinations. ### Competing Interest Statement HJ, YZ, Hui Xie, and WG are listed inventors on U.S. Provisional Application Serial No. 62/993,527 Filed March 23, 2020 entitled "FC-CORONAVIRUS ANTIGEN FUSION PROTEINS, AND NUCLEIC ACIDS, VECTORS, COMPOSITIONS AND METHODS OF USE THEREOF".

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