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

Autor:	Finch CL; Sabin Vaccine Institute, Washington, DC 20037, USA., King TH; Sabin Vaccine Institute, Washington, DC 20037, USA., Alfson KJ; Texas Biomedical Research Institute, San Antonio, TX 78227, USA., Albanese KA; Battelle Biomedical Research Center, Madison County, OH 43162, USA., Smith JNP; Battelle Biomedical Research Center, Madison County, OH 43162, USA., Smock P; Sabin Vaccine Institute, Washington, DC 20037, USA., Jakubik J; Sabin Vaccine Institute, Washington, DC 20037, USA., Goez-Gazi Y; Texas Biomedical Research Institute, San Antonio, TX 78227, USA., Gazi M; Texas Biomedical Research Institute, San Antonio, TX 78227, USA., Dutton JW 3rd; Texas Biomedical Research Institute, San Antonio, TX 78227, USA., Clemmons EA; Texas Biomedical Research Institute, San Antonio, TX 78227, USA., Mattix ME; Nonclinical Pathology Services, LLC, Medina, OH 44256, USA., Carrion R Jr; Texas Biomedical Research Institute, San Antonio, TX 78227, USA., Rudge T Jr; Battelle Biomedical Research Center, Madison County, OH 43162, USA., Ridenour A; Battelle Biomedical Research Center, Madison County, OH 43162, USA., Woodin SF; Sabin Vaccine Institute, Washington, DC 20037, USA., Hunegnaw R; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA., Sullivan NJ; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA., Xu R; Clover Biopharmaceuticals, Boston, MA 02109, USA.
Jazyk:	angličtina
Zdroj:	Vaccines [Vaccines (Basel)] 2022 Nov 15; Vol. 10 (11). Date of Electronic Publication: 2022 Nov 15.
DOI:	10.3390/vaccines10111935
Abstrakt:	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 11 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.
Databáze:	MEDLINE
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