TY - JOUR AU - Tran, Thi Nhu Mai AU - May, Bruce Pearson AU - Ung, Trong Thuan AU - Nguyen, Mai Khoi AU - Nguyen, Thi Thuy Trang AU - Dinh, Van Long AU - Doan, Chinh Chung AU - Tran, The Vinh AU - Khong, Hiep AU - Nguyen, Thi Thanh Truc AU - Hua, Hoang Quoc Huy AU - Nguyen, Viet Anh AU - Ha, Tan Phat AU - Phan, Dang Luu AU - Nguyen, Truong An AU - Bui, Thi Ngoc AU - Tu, Tieu My AU - Nguyen, Thi Theo AU - Le, Thi Thuy Hang AU - Dong, Thi Lan AU - Huynh, Trong Hieu AU - Ho, Phien Huong AU - Le, Nguyen Thanh Thao AU - Truong, Cong Thao AU - Pham, Hoang Phi AU - Luong, Cong Y. AU - Y, Nie Lim AU - Cao, Minh Ngoc AU - Nguyen, Duy Khanh AU - Le, Thi Thanh AU - Vuong, Duc Cuong AU - Nguyen, Le Khanh Hang AU - Do, Minh Si PY - 2021 M3 - Original Research TI - Preclinical Immune Response and Safety Evaluation of the Protein Subunit Vaccine Nanocovax for COVID-19 JO - Frontiers in Immunology UR - https://www.frontiersin.org/articles/10.3389/fimmu.2021.766112 VL - 12 SN - 1664-3224 N2 - The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global health concern. The development of vaccines with high immunogenicity and safety is crucial for controlling the global COVID-19 pandemic and preventing further illness and fatalities. Here, we report the development of a SARS-CoV-2 vaccine candidate, Nanocovax, based on recombinant protein production of the extracellular (soluble) portion of the spike (S) protein of SARS-CoV-2. The results showed that Nanocovax induced high levels of S protein-specific IgG and neutralizing antibodies in three animal models: BALB/c mouse, Syrian hamster, and a non-human primate (Macaca leonina). In addition, a viral challenge study using the hamster model showed that Nanocovax protected the upper respiratory tract from SARS-CoV-2 infection. Nanocovax did not induce any adverse effects in mice (Mus musculus var. albino) and rats (Rattus norvegicus). These preclinical results indicate that Nanocovax is safe and effective. ER -