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Recombinant SARS-CoV-2 spike S1-Fc fusion protein induced high levels of neutralizing responses in nonhuman primates

Wenlin Ren, Hunter Sun, George F. Gao, Jianxin Chen, Sean Sun, Rongqing Zhao, Guang Gao, Yalin Hu, Gan Zhao, Yuxin Chen, Xia Jin, Feng Fang, Jinggong Chen, Qi Wang, Sitao Gong, Wen Gao, Yufei Sun, Junchi Su, Ailiang He, Xin Cheng, Min Li, Chenxi Xia, Maohua Li, Le Sun
doi: https://doi.org/10.1101/2020.04.21.052209
Wenlin Ren
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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Hunter Sun
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
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George F. Gao
3Institute of Microbiology Chinese Academy of Sciences, China
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Jianxin Chen
4ZhenGe Biotechnology Co., LTD, Shanghai, China
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Sean Sun
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
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Rongqing Zhao
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
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Guang Gao
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
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Yalin Hu
5SinoVac, Beijing, China
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Gan Zhao
6Advaccine (Suzhou) Biopharmaceuticals, Co., LTD. Suzhou, Jiangsu, China
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Yuxin Chen
7Department of Lab Medine, Medical School of Nanjing University, Nanjing, Jiangsu, China 210008
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Xia Jin
8Shanghai Public Health Clinical Center, Fudan University, Shanghai, China
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Feng Fang
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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Jinggong Chen
4ZhenGe Biotechnology Co., LTD, Shanghai, China
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Qi Wang
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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Sitao Gong
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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Wen Gao
4ZhenGe Biotechnology Co., LTD, Shanghai, China
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Yufei Sun
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
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Junchi Su
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
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Ailiang He
4ZhenGe Biotechnology Co., LTD, Shanghai, China
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Xin Cheng
6Advaccine (Suzhou) Biopharmaceuticals, Co., LTD. Suzhou, Jiangsu, China
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Min Li
8Shanghai Public Health Clinical Center, Fudan University, Shanghai, China
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Chenxi Xia
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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Maohua Li
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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  • For correspondence: sunl@antibodychina.com limh@antibodychina.com
Le Sun
1AnyGo Technology Co., LTD, D1117 New China International Square, 89 Dayangfan Rd, Beijing, China
2AbMax Biotechnology Co., LTD, 99 Kechuang 14th St., BDA, Beijing 101111, China
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  • For correspondence: sunl@antibodychina.com limh@antibodychina.com
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Abstract

The COVID-19 outbreak has become a global pandemic responsible for over 2,000,000 confirmed cases and over 126,000 deaths worldwide. In this study, we examined the immunogenicity of CHO-expressed recombinant SARS-CoV-2 S1-Fc fusion protein in mice, rabbits, and monkeys as a potential candidate for a COVID-19 vaccine. We demonstrate that the S1-Fc fusion protein is extremely immunogenic, as evidenced by strong antibody titers observed by day 7. Strong virus neutralizing activity was observed on day 14 in rabbits immunized with the S1-Fc fusion protein using a pseudovirus neutralization assay. Most importantly, in less than 20 days and three injections of the S1-Fc fusion protein, two monkeys developed higher virus neutralizing titers than a recovered COVID-19 patient in a live SARS-CoV-2 infection assay. Our data strongly suggests that the CHO-expressed SARS-CoV-2 S1-Fc recombinant protein could be a strong candidate for vaccine development against COVID-19.

Highlights

  1. CHO-expressed S1-Fc protein is very immunogenic in various animals and can rapidly induce strong antibody production

  2. S1-Fc protein solicits strong neutralizing activities against live virus

  3. Stable CHO cell line expressing 50 mg/L of S1-Fc and a 3,000 L Bioreactor can produce 3 million doses of human COVID-19 vaccine every 10 days, making it an accessible and affordable option for worldwide vaccination

Competing Interest Statement

The authors have declared no competing interest.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
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Posted April 23, 2020.
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Recombinant SARS-CoV-2 spike S1-Fc fusion protein induced high levels of neutralizing responses in nonhuman primates
Wenlin Ren, Hunter Sun, George F. Gao, Jianxin Chen, Sean Sun, Rongqing Zhao, Guang Gao, Yalin Hu, Gan Zhao, Yuxin Chen, Xia Jin, Feng Fang, Jinggong Chen, Qi Wang, Sitao Gong, Wen Gao, Yufei Sun, Junchi Su, Ailiang He, Xin Cheng, Min Li, Chenxi Xia, Maohua Li, Le Sun
bioRxiv 2020.04.21.052209; doi: https://doi.org/10.1101/2020.04.21.052209
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Recombinant SARS-CoV-2 spike S1-Fc fusion protein induced high levels of neutralizing responses in nonhuman primates
Wenlin Ren, Hunter Sun, George F. Gao, Jianxin Chen, Sean Sun, Rongqing Zhao, Guang Gao, Yalin Hu, Gan Zhao, Yuxin Chen, Xia Jin, Feng Fang, Jinggong Chen, Qi Wang, Sitao Gong, Wen Gao, Yufei Sun, Junchi Su, Ailiang He, Xin Cheng, Min Li, Chenxi Xia, Maohua Li, Le Sun
bioRxiv 2020.04.21.052209; doi: https://doi.org/10.1101/2020.04.21.052209

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