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.

doi:10.1101/2020.09.09.285445

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bioRxiv · 10.1101/2020.09.09.285445

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

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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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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. Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion Inactivated SARS-CoV-2 Vaccine - BBV152. https://doi.org/10.1101/2020.09.09.285445

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