Vaccines (Nov 2022)

Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs

  • Courtney L. Finch,
  • Thomas H. King,
  • Kendra J. Alfson,
  • Katie A. Albanese,
  • Julianne N. P. Smith,
  • Paul Smock,
  • Jocelyn Jakubik,
  • Yenny Goez-Gazi,
  • Michal Gazi,
  • John W. Dutton,
  • Elizabeth A. Clemmons,
  • Marc E. Mattix,
  • Ricardo Carrion,
  • Thomas Rudge,
  • Alex Ridenour,
  • Sovann F. Woodin,
  • Ruth Hunegnaw,
  • Nancy J. Sullivan,
  • Rong Xu

DOI
https://doi.org/10.3390/vaccines10111935
Journal volume & issue
Vol. 10, no. 11
p. 1935

Abstract

Read online

Marburg virus (MARV) is a virus of high human consequence with a case fatality rate of 24–88%. The global health and national security risks posed by Marburg virus disease (MVD) underscore the compelling need for a prophylactic vaccine, but no candidate has yet reached regulatory approval. Here, we evaluate a replication-defective chimpanzee adenovirus type 3 (ChAd3)-vectored MARV Angola glycoprotein (GP)-expressing vaccine against lethal MARV challenge in macaques. The ChAd3 platform has previously been reported to protect against the MARV-related viruses, Ebola virus (EBOV) and Sudan virus (SUDV), and MARV itself in macaques, with immunogenicity demonstrated in macaques and humans. In this study, we present data showing 100% protection against MARV Angola challenge (versus 0% control survival) and associated production of GP-specific IgGs generated by the ChAd3-MARV vaccine following a single dose of 1 × 1011 virus particles prepared in a new clinical formulation buffer designed to enhance product stability. These results are consistent with previously described data using the same vaccine in a different formulation and laboratory, demonstrating the reproducible and robust protective efficacy elicited by this promising vaccine for the prevention of MVD. Additionally, a qualified anti-GP MARV IgG ELISA was developed as a critical pre-requisite for clinical advancement and regulatory approval.

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