Immunogenicity and Efficacy of TNX-1800, A Live Virus Recombinant Poxvirus Vaccine Candidate, against SARS-CoV-2 Challenge in Nonhuman Primates-Reference-Cited by-同舟云学术

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

Published:2023-11-02 Issue:11 Volume:11 Page:1682
ISSN:2076-393X
Container-title:Vaccines
language:en
Short-container-title:Vaccines

Author:

Awasthi Mayanka¹^ORCID,Macaluso Anthony¹,Myscofski Dawn¹,Prigge Jon²,Koide Fusataka³,Noyce Ryan S.⁴^ORCID,Fogarty Siobhan⁵,Stillwell Helen⁶⁷,Goebel Scott J.¹,Daugherty Bruce⁷,Nasar Farooq¹,Bavari Sina¹,Lederman Seth⁸^ORCID

Affiliation:

1. Tonix Pharmaceuticals, Frederick, MD 21701, USA

2. BioQual, Rockville, MD 20850, USA

3. Southern Research, Birmingham, AL 35205, USA

4. Department of Medical Microbiology & Immunology, Li Ka Shing Institute of Virology, University of Alberta, Edmonton, AB T6G 2R3, Canada

5. Tonix Pharma Limited, A96 HW25 Dublin, Ireland

6. Department of Microbiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA

7. Tonix Pharmaceuticals, Chatham, NJ 07928, USA

8. Tonix Pharmaceuticals, Dartmouth, MA 02748, USA

Abstract

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.

Funder

Tonix Pharmaceuticals, Inc.

Publisher

MDPI AG

Subject

Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology

Link

https://www.mdpi.com/2076-393X/11/11/1682/pdf

Reference23 articles.

1. A new coronavirus associated with human respiratory disease in China;Wu;Nature,2020

2. (2023, September 27). HO Coronavirus Disease (COVID-19) Dashboard. Available online: https://covid19.who.int/.

3. Vaccination greatly reduces disease, disability, death and inequity worldwide;Andre;Bull. World Health Organ.,2008

4. Impact of COVID-19 vaccination on the risk of developing long-COVID and on existing long-COVID symptoms: A systematic review;Notarte;eClinicalMedicine,2022

5. Vaccination is the most effective and best way to avoid the disease of COVID-19;Lotfi;Immun. Inflamm. Dis.,2023