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Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion Inactivated SARS-CoV-2 Vaccine - BBV152

Ganneru, B.; Jogdand, H.; Dharam, V. K.; Reddy, N.; Prasad, S. D.; Vellimudu, S.; Ella, K. M.; Ravikrishnan, R.; Awasthi, A.; Jose, J.; Rao, P.; Kumar, D.; Ella, R.; Abraham, P.; Yadav, P.; Sapkal, G. N.; Shete, A.; Desphande, G. R.; Mohandas, S.; Basu, A.; Gupta, N.; Bhargava, B.; Mohan, K. V.

2020-09-09 immunology
10.1101/2020.09.09.285445 bioRxiv
Show abstract

We report the development and evaluation of safety and immunogenicity of a whole virion inactivated SARS-COV-2 vaccine (BBV152), adjuvanted with aluminium hydroxide gel (Algel), or a novel TLR7/8 agonist adsorbed 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, BBV152. Product development and manufacturing were carried out in a BSL-3 facility. Immunogenicity was determined at two antigen concentrations (3g and 6g), 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, at both concentrations, in all three species with excellent safety profiles. The inactivated vaccine formulation containing 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.

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