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

Brunda Ganneru, Harsh Jogdand, Vijaya Kumar Dharam, Narasimha Reddy Molugu, Sai D Prasad, Srinivas Vellimudu, Krishna M Ella, Rajaram Ravikrishnan, Amit Awasthi, Jomy Jose, Panduranga Rao, Deepak Kumar, View ORCID ProfileRaches Ella, Priya Abraham, Pragya Yadav, Gajanan N Sapkal, Anita Shete, Gururaj Rao Desphande, Sreelekshmy Mohandas, Atanu Basu, Nivedita Gupta, Krishna Mohan Vadrevu
doi: https://doi.org/10.1101/2020.09.09.285445
Brunda Ganneru
1Bharat Biotech International Ltd, Hyderabad, India
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Harsh Jogdand
1Bharat Biotech International Ltd, Hyderabad, India
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Vijaya Kumar Dharam
1Bharat Biotech International Ltd, Hyderabad, India
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Narasimha Reddy Molugu
1Bharat Biotech International Ltd, Hyderabad, India
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Sai D Prasad
1Bharat Biotech International Ltd, Hyderabad, India
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Srinivas Vellimudu
1Bharat Biotech International Ltd, Hyderabad, India
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Krishna M Ella
1Bharat Biotech International Ltd, Hyderabad, India
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Rajaram Ravikrishnan
2RCC Labs, Hyderabad, Faridabad, India
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Amit Awasthi
3Translational Health Sciences and Technology Institute, Faridabad, India
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Jomy Jose
2RCC Labs, Hyderabad, Faridabad, India
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Panduranga Rao
1Bharat Biotech International Ltd, Hyderabad, India
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Deepak Kumar
1Bharat Biotech International Ltd, Hyderabad, India
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Raches Ella
1Bharat Biotech International Ltd, Hyderabad, India
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  • ORCID record for Raches Ella
  • For correspondence: ellar@bharatbiotech.com
Priya Abraham
4National Institute of Virology-Indian Council of Medical Research, India
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Pragya Yadav
4National Institute of Virology-Indian Council of Medical Research, India
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Gajanan N Sapkal
4National Institute of Virology-Indian Council of Medical Research, India
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Anita Shete
4National Institute of Virology-Indian Council of Medical Research, India
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Gururaj Rao Desphande
4National Institute of Virology-Indian Council of Medical Research, India
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Sreelekshmy Mohandas
4National Institute of Virology-Indian Council of Medical Research, India
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Atanu Basu
4National Institute of Virology-Indian Council of Medical Research, India
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Nivedita Gupta
5Indian Council of Medical Research, India
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Krishna Mohan Vadrevu
1Bharat Biotech International Ltd, Hyderabad, India
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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 (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, 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-γ+ CD4 T lymphocyte response. Our results support further development for Phase I/II clinical trials in humans.

Competing Interest Statement

The authors have declared no competing interest.

Footnotes

  • Removal of one Co-author: Balaram Bhargav.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license.
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Posted September 12, 2020.
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Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152
Brunda Ganneru, Harsh Jogdand, Vijaya Kumar Dharam, Narasimha Reddy Molugu, Sai D Prasad, Srinivas Vellimudu, Krishna M Ella, Rajaram Ravikrishnan, Amit Awasthi, Jomy Jose, Panduranga Rao, Deepak Kumar, Raches Ella, Priya Abraham, Pragya Yadav, Gajanan N Sapkal, Anita Shete, Gururaj Rao Desphande, Sreelekshmy Mohandas, Atanu Basu, Nivedita Gupta, Krishna Mohan Vadrevu
bioRxiv 2020.09.09.285445; doi: https://doi.org/10.1101/2020.09.09.285445
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Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152
Brunda Ganneru, Harsh Jogdand, Vijaya Kumar Dharam, Narasimha Reddy Molugu, Sai D Prasad, Srinivas Vellimudu, Krishna M Ella, Rajaram Ravikrishnan, Amit Awasthi, Jomy Jose, Panduranga Rao, Deepak Kumar, Raches Ella, Priya Abraham, Pragya Yadav, Gajanan N Sapkal, Anita Shete, Gururaj Rao Desphande, Sreelekshmy Mohandas, Atanu Basu, Nivedita Gupta, Krishna Mohan Vadrevu
bioRxiv 2020.09.09.285445; doi: https://doi.org/10.1101/2020.09.09.285445

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