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

Front Immunol. 2021 Dec 6:12:766112. doi: 10.3389/fimmu.2021.766112. eCollection 2021.

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.

Keywords: ACE2; CHO; COVID-19; RBD; SARS-CoV-2.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antibodies, Neutralizing / immunology
  • Antibodies, Viral / immunology
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines / immunology*
  • COVID-19 Vaccines / toxicity*
  • Cricetinae
  • Immunogenicity, Vaccine / immunology*
  • Macaca
  • Mice
  • Rats
  • SARS-CoV-2
  • Spike Glycoprotein, Coronavirus / immunology*
  • Vaccines, Synthetic / immunology
  • Vaccines, Synthetic / toxicity

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • COVID-19 Vaccines
  • Spike Glycoprotein, Coronavirus
  • Vaccines, Synthetic
  • spike protein, SARS-CoV-2