Development of a thermostable SARS-CoV-2 variant-based bivalent protein vaccine with cross-neutralizing potency against Omicron subvariants

SARS-CoV-2 variants have posed significant challenges to the hopes of using ancestral strain-based vaccines to address the risk of breakthrough infection by variants. We designed and developed a bivalent vaccine based on SARS-CoV-2 Alpha and Beta variants (named SCTV01C). SCTV01C antigens were stabl...

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Published in:Virology (New York, N.Y.) N.Y.), 2022-11, Vol.576, p.61-68
Main Authors: Wang, Rui, Huang, Xun, Cao, Tianshu, Sun, Chunyun, Luo, Dan, Qiu, Hongying, Wu, Mei, Huang, Xingyao, Yu, Chulin, Li, Jing, Kong, Desheng, Ma, Juan, Zhang, Xiao, Hu, Ping, Zhang, Yanjing, Luo, Chunxia, Zhao, Hui, Li, Yuchang, Deng, Yongqiang, Qin, Chengfeng, Xie, Liangzhi
Format: Article
Language:English
Subjects:
Animals
Antibodies, Neutralizing
Antibodies, Viral
COVID-19 - prevention & control
Cross-neutralization
Humans
Mice
Multivalent protein vaccine
Omicron subvariants
SARS-CoV-2 - genetics
SARS-CoV-2 variant
Squalene
Thermal stability
Vaccines, Combined
Viral Vaccines - genetics
Water
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Summary:SARS-CoV-2 variants have posed significant challenges to the hopes of using ancestral strain-based vaccines to address the risk of breakthrough infection by variants. We designed and developed a bivalent vaccine based on SARS-CoV-2 Alpha and Beta variants (named SCTV01C). SCTV01C antigens were stable at 25 oC for at least 6 months. In the presence of a squalene-based oil-in-water adjuvant SCT-VA02B, SCTV01C showed significant protection efficacy against antigen-matched Beta variant, with favorable safety profiles in rodents. Notably, SCTV01C exhibited cross-neutralization capacity against Omicron subvariants (BA.1, BA.1.1, BA.2, BA.3, and BA.4/5) in mice, superior to a WT (D614G)-based vaccine, which reinforced our previously published findings that SCTV01C exhibited broad-spectrum neutralizing potencies against over a dozen pre-Omicron variants and the Omicron BA.1 variant. In summary, variant-based multivalent protein vaccine could be a platform approach to address the challenging issues of emerging variants, vaccine hesitancy and the needs of affordable and thermal stable vaccines. •SCTV01C antigens were stable at 25 oC for at least 6 months.•Potent efficacy of SCTV01C against antigen-matched SARS-CoV-2 variant strain.•Superior cross-neutralizing potency of SCTV01C against Omicron subvariants.•SCTV01C exhibited favorable safety profiles in preclinical safety studies.
ISSN:0042-6822
1096-0341
DOI:10.1016/j.virol.2022.09.003