| Literature DB >> 33723528 |
Brunda Ganneru1, Harsh Jogdand1, Vijaya Kumar Daram1, Dipankar Das1, Narasimha Reddy Molugu1, Sai D Prasad1, Srinivas V Kannappa1, Krishna M Ella1, Rajaram Ravikrishnan2, Amit Awasthi3, Jomy Jose2, Panduranga Rao1, Deepak Kumar1, Raches Ella1, Priya Abraham4, Pragya D Yadav4, Gajanan N Sapkal4, Anita Shete-Aich4, Gururaj Desphande4, Sreelekshmy Mohandas4, Atanu Basu4, Nivedita Gupta5, Krishna Mohan Vadrevu1.
Abstract
We report the development and evaluation of safety and immunogenicity of a whole virion inactivated (WVI) SARS-CoV-2 vaccine (BBV152), adjuvanted with aluminum hydroxide gel (Algel), or TLR7/8 agonist chemisorbed Algel. We used a well-characterized SARS-CoV-2 strain and an established Vero cell platform to produce large-scale GMP-grade highly purified inactivated antigen. Product development and manufacturing process were carried out in a BSL-3 facility. Immunogenicity and safety were determined at two antigen concentrations (3μg and 6μg), with two different adjuvants, in mice, rats, and rabbits. Our results show that BBV152 vaccine formulations generated significantly high antigen-binding and neutralizing antibody titers (NAb), at both concentrations, in all three species with excellent safety profiles. The inactivated vaccine formulation contains TLR7/8 agonist adjuvant-induced Th1-biased antibody responses with elevated IgG2a/IgG1 ratio and increased levels of SARS-CoV-2-specific IFN-γ+ CD4+ T lymphocyte response. Our results support further development for phase I/II clinical trials in humans.Entities:
Keywords: Immune Response; Immunology; Virology
Year: 2021 PMID： 33723528 PMCID： PMC7944858 DOI： 10.1016/j.isci.2021.102298
Source DB: PubMed Journal: iScience ISSN： 2589-0042