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A Novel SARS-CoV-2 Multitope Protein/Peptide Vaccine Candidate is Highly Immunogenic and Prevents Lung Infection in an AAV hACE2 Mouse Model and non-human primates

By Farshad Guirakhoo, Lucy Kuo, James Peng, Juin Hua Huang, Ben Kuo, Feng Lin, Yaw-Jen Liu, Zhi Liu, Grace Wu, Shuang Ding, Kou-Liang Hou, Jennifer Cheng, Vicky Yang, Hank Jiang, Jason Wang, Tony Chen, WeiGuo Xia, Ed Lin, Chung Ho Hung, Hui-Jung Chen, Zhonghao Shih, Yi-Ling Lin, Shixia Wang, Valorie Ryan, Brandon T. Schurter, Mei Mei Hu, Gray Heppner, Delphine C. Malherbe, Alexander Bukreyev, Michael Hellerstein, Thomas P. Monath, Chang Yi Wang

Posted 30 Nov 2020
bioRxiv DOI: 10.1101/2020.11.30.399154

A novel multitope protein-peptide vaccine against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and disease is described in this report. The initial development and characterization experiments are presented along with proof-of-concept studies for the vaccine candidate UB-612. UB-612 consists of eight components rationally designed for induction of potently neutralizing antibodies and broad T cell responses against SARS-CoV-2: the S1-RBD-sFc fusion protein, six synthetic peptides (one universal peptide and five SARS-CoV-2-derived peptides), a proprietary CpG TLR-9 agonist at low concentration as an excipient, and aluminum phosphate adjuvant. Through immunogenicity studies in Guinea pigs and rats, we optimized the design of protein/peptide immunogens and selected an adjuvant system, yielding a vaccine that provides excellent S1-RBD binding and high neutralizing antibody responses, robust cellular responses, and a Th1-oriented response at low doses. In challenge studies, UB-612 vaccination reduced viral load and prevented development of disease in mouse and non-human primate challenge models. With a Phase 1 trial completed, a Phase 2 trial ongoing in Taiwan, and additional trials planned to support global authorizations, UB-612 is a highly promising and differentiated vaccine candidate for prevention of SARS-CoV-2 infection and COVID-19 disease.

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