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Deprecated: Implicit conversion from float 265.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 iScience 2021 ; 24 (4): 102298 Nephropedia Template TP
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Th1 skewed immune response of whole virion inactivated SARS CoV 2 vaccine and its safety evaluation #MMPMID33723528
Ganneru B; Jogdand H; Daram VK; Das D; Molugu NR; Prasad SD; Kannappa SV; Ella KM; Ravikrishnan R; Awasthi A; Jose J; Rao P; Kumar D; Ella R; Abraham P; Yadav PD; Sapkal GN; Shete-Aich A; Desphande G; Mohandas S; Basu A; Gupta N; Vadrevu KM
iScience 2021[Apr]; 24 (4): 102298 PMID33723528show ga
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 (3mug and 6mug), 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-gamma(+) CD4(+) T lymphocyte response. Our results support further development for phase I/II clinical trials in humans.