CpG-adjuvanted stable prefusion SARS-CoV-2 spike protein protected hamsters from SARS-CoV-2 challenge

Lien, Chia-En; Lin, Yi-Jiun; Chen, Charles; Lian, Wei-Cheng; Kuo, Tsun-Yung; Campbell, John D.; Traquina, Paula; Lin, Meei-Yun; Liu, Luke Tzu-Chi; Chuang, Ya-Shan; Ko, Hui-Ying; Liao, Chun-Che; Chen, Yen-Hui; Jan, Jia-Tsrong; Ma, Hsiu-Hua; Sun, Cheng-Pu; Lin, Yin-Shiou; Wu, Ping-Yi; Wang, Yu-Chiuan; Tao, Mi-Hua; Lin, Yi-Ling

The COVID-19 pandemic presents an unprecedented challenge to global public health. Rapid development and deployment of safe and effective vaccines are imperative to control the pandemic. In the current study, we applied our adjuvanted stable prefusion SARS-CoV-2 spike (S-2P)-based vaccine, MVC-COV1901, to hamster models to demonstrate immunogenicity and protection from virus challenge. Golden Syrian hamsters immunized intramuscularly with two injections of 1 µg or 5 µg of S-2P adjuvanted with CpG 1018 and aluminum hydroxide (alum) were challenged intranasally with SARS-CoV-2. Prior to virus challenge, the vaccine induced high levels of neutralizing antibodies with 10,000-fold higher IgG level and an average of 50-fold higher pseudovirus neutralizing titers in either dose groups than vehicle or adjuvant control groups. Six days after infection, vaccinated hamsters did not display any weight loss associated with infection and had significantly reduced lung pathology and most importantly, lung viral load levels were reduced to lower than detection limit compared to unvaccinated animals. Vaccination with either 1 μg or 5 μg of adjuvanted S-2P produced comparable immunogenicity and protection from infection. This study builds upon our previous results to support the clinical development of MVC-COV1901 as a safe, highly immunogenic, and protective COVID-19 vaccine.