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SARS-CoV-2 proteins

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    First-in-Human Trial of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike MESHD SARS-CoV-2 Spike PROTEIN Protein Vaccine with Adjuvant of Aluminum Hydroxide and CpG 1018

    Authors: Szu-Min Hsieh; Wang-Da Liu; Yu-Shan Huang; Yi-Jiun Lin; Erh-Fang Hsieh; Wei-Cheng Lian; Charles Chen; I-Chen Tai; Shan-Chwen Chang

    doi:10.1101/2021.03.31.21254668 Date: 2021-04-06 Source: medRxiv

    Design This is a phase 1, dose-escalation open-label trial to evaluate the safety and immunogenicity of MVC-COV1901, a recombinant stabilized prefusion SARS-CoV-2 spike PROTEIN ( S-2P HGNC) protein vaccine with adjuvant of aluminum hydroxide and CpG 1018. Methods We enrolled 45 healthy adults from 20 to 49 years of age to be administered with two vaccinations of MVC-COV1901 in a low dose (LD), middle dose (MD), and high dose ( HD MESHD) of spike protein PROTEIN at 28 days apart. There were 15 participants in each dose group, and all of them were followed up for 28 days after the second vaccination at the time of interim analysis. Adverse events (AEs) and laboratory data were recorded for safety evaluation. Blood samples were collected for wild-type SARS-CoV-2 and pseudovirus neutralization assays as well as SARS-CoV-2 spike PROTEIN-specific immunoglobulin G (IgG) at various times. Overall, the study duration will be 7 months. Results Solicited events were mostly mild and similar in the participants of all three dose groups. No subject experienced fever MESHD. There were no serious nor adverse events of special interest at the time point of this interim report. After the second vaccination, the SARS-CoV-2 spike PROTEIN specific IgG titers increased with peak geometric mean titers at 7178.245 (LD), 7746.086 (MD), and 11220.58 ( HD MESHD), respectively. Serum neutralizing activity was detected by two methods in all participants of MD MESHD and HD MESHD groups, with geometric mean values generally comparable to those of a panel of control convalescent serum specimens. All of the participants in the MD MESHD and HD MESHD groups were seroconverted after the second vaccination. Conclusions The MVC-COV1901 vaccine is safe and elicits remarkable immune responses especially in the MD MESHD and HD MESHD groups.

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MeSH Disease
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SARS-CoV-2 Proteins


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