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

Autor: 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
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Vaccines, Vol 10, Iss 11, p 1935 (2022)
Druh dokumentu: article
ISSN: 2076-393X
DOI: 10.3390/vaccines10111935
Popis: 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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