Journal Article

Preclinical Immune Response and Safety Evaluation of the Protein Subunit Vaccine Nanocovax for COVID-19

Nguyen, Thi Thuy Trang, Nguyen, Duy Khanh, Do, Minh Si, Nguyen, Thi Theo, Le, Thi Thanh, Ung, Trong Thuan, Bui, Thi Ngoc, Phan, Dang Luu, Tu, Tieu My, Doan, Chinh Chung, Tran, Thi Nhu Mai, May, Bruce Pearson, Le, Thi Thuy Hang, Huynh, Trong Hieu, Nguyen, Viet Anh, Vuong, Duc Cuong, Luong, Cong Y., Ha, Tan Phat, Hua, Hoang Quoc Huy, Cao, Minh Ngoc, Dinh, Van Long, Nguyen, Mai Khoi, Tran, The Vinh, Khong, Hiep, Nguyen, Le Khanh Hang, Nguyen, Truong An, Y, Nie Lim, Le, Nguyen Thanh Thao, Pham, Hoang Phi, Truong, Cong Thao, Nguyen, Thi Thanh Truc, Ho, Phien Huong, Dong, Thi Lan

2021

Overview

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.

• Publisher: Frontiers Media SA,Frontiers Media S.A
• Subject: ACE2 / Animal models / Animals / Antibodies / Antibodies, Neutralizing - immunology / Antibodies, Viral - immunology / Cells / CHO / Chromatography / Coronaviruses / COVID-19 / COVID-19 - prevention & control / COVID-19 vaccines / COVID-19 Vaccines - immunology / COVID-19 Vaccines - toxicity / Cricetinae / Enzymes / FDA approval / Immune response / Immunogenicity / Immunogenicity, Vaccine - immunology / Immunoglobulin G / Immunology / Macaca / Membranes / Mice / Pandemics / Peptides / Plasmids / Protein expression / Proteins / Public health / Rats / RBD / SARS-CoV-2 / Severe acute respiratory syndrome coronavirus 2 / Spike Glycoprotein, Coronavirus - immunology / Vaccines / Vaccines, Synthetic - immunology / Vaccines, Synthetic - toxicity