Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine

Nature. 2022 Jan;601(7893):410-414. doi: 10.1038/s41586-021-04231-6. Epub 2021 Nov 18.

Abstract

The CVnCoV (CureVac) mRNA vaccine for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was recently evaluated in a phase 2b/3 efficacy trial in humans1. CV2CoV is a second-generation mRNA vaccine containing non-modified nucleosides but with optimized non-coding regions and enhanced antigen expression. Here we report the results of a head-to-head comparison of the immunogenicity and protective efficacy of CVnCoV and CV2CoV in non-human primates. We immunized 18 cynomolgus macaques with two doses of 12 μg lipid nanoparticle-formulated CVnCoV or CV2CoV or with sham (n = 6 per group). Compared with CVnCoV, CV2CoV induced substantially higher titres of binding and neutralizing antibodies, memory B cell responses and T cell responses as well as more potent neutralizing antibody responses against SARS-CoV-2 variants, including the Delta variant. Moreover, CV2CoV was found to be comparably immunogenic to the BNT162b2 (Pfizer) vaccine in macaques. Although CVnCoV provided partial protection against SARS-CoV-2 challenge, CV2CoV afforded more robust protection with markedly lower viral loads in the upper and lower respiratory tracts. Binding and neutralizing antibody titres were correlated with protective efficacy. These data demonstrate that optimization of non-coding regions can greatly improve the immunogenicity and protective efficacy of a non-modified mRNA SARS-CoV-2 vaccine in non-human primates.

Publication types

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

MeSH terms

  • Animals
  • Antibodies, Neutralizing / immunology
  • Antibodies, Viral / immunology
  • BNT162 Vaccine / immunology
  • COVID-19 / immunology
  • COVID-19 / prevention & control*
  • COVID-19 / virology
  • COVID-19 Vaccines / genetics*
  • COVID-19 Vaccines / immunology*
  • COVID-19 Vaccines / standards
  • Female
  • Immunogenicity, Vaccine*
  • Macaca fascicularis / immunology
  • Male
  • Memory B Cells / immunology
  • Nucleosides / chemistry*
  • Nucleosides / genetics
  • Respiratory System / immunology
  • Respiratory System / virology
  • SARS-CoV-2 / immunology
  • T-Lymphocytes / immunology
  • Vaccines, Synthetic / genetics*
  • Vaccines, Synthetic / immunology*
  • Vaccines, Synthetic / standards
  • Viral Load
  • mRNA Vaccines / genetics*
  • mRNA Vaccines / immunology*
  • mRNA Vaccines / standards

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • COVID-19 Vaccines
  • Nucleosides
  • Vaccines, Synthetic
  • mRNA Vaccines
  • BNT162 Vaccine

Supplementary concepts

  • SARS-CoV-2 variants