Immunogenicity and Efficacy of TNX-1800, A Live Virus Recombinant Poxvirus Vaccine Candidate, against SARS-CoV-2 Challenge in Nonhuman Primates.

Autor:	Awasthi M; Tonix Pharmaceuticals, Frederick, MD 21701, USA., Macaluso A; Tonix Pharmaceuticals, Frederick, MD 21701, USA., Myscofski D; Tonix Pharmaceuticals, Frederick, MD 21701, USA., Prigge J; BioQual, Rockville, MD 20850, USA., Koide F; Southern Research, Birmingham, AL 35205, USA., Noyce RS; Department of Medical Microbiology & Immunology, Li Ka Shing Institute of Virology, University of Alberta, Edmonton, AB T6G 2R3, Canada., Fogarty S; Tonix Pharma Limited, A96 HW25 Dublin, Ireland., Stillwell H; Department of Microbiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA.; Tonix Pharmaceuticals, Chatham, NJ 07928, USA., Goebel SJ; Tonix Pharmaceuticals, Frederick, MD 21701, USA., Daugherty B; Tonix Pharmaceuticals, Chatham, NJ 07928, USA., Nasar F; Tonix Pharmaceuticals, Frederick, MD 21701, USA., Bavari S; Tonix Pharmaceuticals, Frederick, MD 21701, USA., Lederman S; Tonix Pharmaceuticals, Dartmouth, MA 02748, USA.
Jazyk:	angličtina
Zdroj:	Vaccines [Vaccines (Basel)] 2023 Nov 02; Vol. 11 (11). Date of Electronic Publication: 2023 Nov 02.
DOI:	10.3390/vaccines11111682
Abstrakt:	TNX-1800 is a synthetically derived live recombinant chimeric horsepox virus (rcHPXV) vaccine candidate expressing Wuhan SARS-CoV-2 spike (S) protein. The primary objective of this study was to evaluate the immunogenicity and efficacy of TNX-1800 in two nonhuman primate species challenged with USA-WA1/2020 SARS-CoV-2. TNX-1800 vaccination was well tolerated with no serious adverse events or significant changes in clinical parameters. A single dose of TNX-1800 generated humoral responses in African Green Monkeys and Cynomolgus Macaques, as measured by the total binding of anti-SARS-CoV-2 S IgG and neutralizing antibody titers against the USA-WA1/2020 strain. In addition, a single dose of TNX-1800 induced an interferon-gamma (IFN-γ)-mediated T-cell response in Cynomolgus Macaques. Following challenge with SARS-CoV-2, African Green and Cynomolgus Macaques exhibited rapid clearance of virus in the upper and lower respiratory tract. Future studies will assess the efficacy of TNX-1800 against newly emerging variants and demonstrate its safety in humans.
Databáze:	MEDLINE
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