Engineered SARS-CoV-2 receptor binding domain improves manufacturability in yeast and immunogenicity in mice

Proc Natl Acad Sci U S A. 2021 Sep 21;118(38):e2106845118. doi: 10.1073/pnas.2106845118.

Abstract

Global containment of COVID-19 still requires accessible and affordable vaccines for low- and middle-income countries (LMICs). Recently approved vaccines provide needed interventions, albeit at prices that may limit their global access. Subunit vaccines based on recombinant proteins are suited for large-volume microbial manufacturing to yield billions of doses annually, minimizing their manufacturing cost. These types of vaccines are well-established, proven interventions with multiple safe and efficacious commercial examples. Many vaccine candidates of this type for SARS-CoV-2 rely on sequences containing the receptor-binding domain (RBD), which mediates viral entry to cells via ACE2. Here we report an engineered sequence variant of RBD that exhibits high-yield manufacturability, high-affinity binding to ACE2, and enhanced immunogenicity after a single dose in mice compared to the Wuhan-Hu-1 variant used in current vaccines. Antibodies raised against the engineered protein exhibited heterotypic binding to the RBD from two recently reported SARS-CoV-2 variants of concern (501Y.V1/V2). Presentation of the engineered RBD on a designed virus-like particle (VLP) also reduced weight loss in hamsters upon viral challenge.

Keywords: Pichia pastoris; SARS-CoV-2; manufacturability; protein vaccine.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antibodies, Viral / immunology
  • Antigens, Viral
  • Binding Sites
  • COVID-19 / prevention & control*
  • COVID-19 / virology
  • COVID-19 Vaccines / economics
  • COVID-19 Vaccines / immunology*
  • Humans
  • Immunogenicity, Vaccine
  • Mice
  • Mice, Inbred BALB C
  • Models, Molecular
  • Protein Binding
  • Protein Conformation
  • Protein Engineering / methods*
  • SARS-CoV-2 / metabolism*
  • Saccharomycetales / metabolism
  • Spike Glycoprotein, Coronavirus / genetics*
  • Vaccines, Subunit

Substances

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

Supplementary concepts

  • Komagataella pastoris