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
Author Information
Courtney L Finch: Sabin Vaccine Institute, Washington, DC 20037, USA.
Thomas H King: Sabin Vaccine Institute, Washington, DC 20037, USA.
Kendra J Alfson: Texas Biomedical Research Institute, San Antonio, TX 78227, USA. ORCID
Katie A Albanese: Battelle Biomedical Research Center, Madison County, OH 43162, USA.
Julianne N P Smith: Battelle Biomedical Research Center, Madison County, OH 43162, USA.
Paul Smock: Sabin Vaccine Institute, Washington, DC 20037, USA.
Jocelyn Jakubik: Sabin Vaccine Institute, Washington, DC 20037, USA.
Yenny Goez-Gazi: Texas Biomedical Research Institute, San Antonio, TX 78227, USA.
Michal Gazi: Texas Biomedical Research Institute, San Antonio, TX 78227, USA.
John W Dutton: Texas Biomedical Research Institute, San Antonio, TX 78227, USA. ORCID
Elizabeth A Clemmons: Texas Biomedical Research Institute, San Antonio, TX 78227, USA.
Marc E Mattix: Nonclinical Pathology Services, LLC, Medina, OH 44256, USA.
Ricardo Carrion: Texas Biomedical Research Institute, San Antonio, TX 78227, USA.
Thomas Rudge: Battelle Biomedical Research Center, Madison County, OH 43162, USA.
Alex Ridenour: Battelle Biomedical Research Center, Madison County, OH 43162, USA.
Sovann F Woodin: Sabin Vaccine Institute, Washington, DC 20037, USA.
Ruth Hunegnaw: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.
Nancy J Sullivan: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.
Rong Xu: Clover Biopharmaceuticals, Boston, MA 02109, USA.
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 �� 10 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.
