Abstract
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.
Highlights
The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global health emergency [1]
Like SARS-CoV (79% genomic sequence identity) [3], SARS-CoV-2 utilizes the receptor angiotensin-converting enzyme 2 (ACE2), which is expressed on numerous cells
To generate the SAR-CoV-2 antigen for vaccine development, we designed an optimized DNA sequence encoding the extracellular domain sequence of the S protein, which has some changes in 1) the S1/S2 furin cleavage site to minimize the cleavage of S1/S2 during protein production, 2) the two proline residues in the S2 domain [986-987] to enhance prefusion-stabilized SARS-CoV-2 spikes, and 3) the 9-arginine residue in the C-terminus (Figure 1)
Summary
The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global health emergency [1]. Since it was first reported in Wuhan, China, at the end of 2019, there have been over 165 million cases worldwide and nearly 3.5 million deaths as of May 2021 [2], with no obvious short-term resolution. Like SARS-CoV (79% genomic sequence identity) [3], SARS-CoV-2 utilizes the receptor angiotensin-converting enzyme 2 (ACE2), which is expressed on numerous cells The S protein of SARS-CoV-2 plays a vital role in the invasive process
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