Back to Search Start Over

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

Authors :
Pragya D Yadav
Priya Abraham
Anita M. Shete
Panduranga Rao
Gajanan Sapkal
Narasimha Reddy Molugu
Gururaj Rao Desphande
Atanu Basu
Nivedita Gupta
Amit Awasthi
Sreelekshmy Mohandas
Brunda Ganneru
Vijaya Kumar Daram
Jomy Jose
Deepak Kumar
Rajaram Ravikrishnan
Srinivas V. Kannappa
Krishna Mohan Vadrevu
Raches Ella
Sai Prasad
Harsh Jogdand
Krishna Murthy Ella
Source :
SSRN Electronic Journal.
Publication Year :
2020
Publisher :
Elsevier BV, 2020.

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 chemisorbed Algel. We used a well-characterizedSARS-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 (3µgand 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-Υ+ CD4 T lymphocyte response. Our results support further development for Phase I/II clinical trials in humans. Funding: This work was supported and funded by Bharat Biotech International Limited and the Indian Council of Medical Research. Conflict of Interest: All authors have no personal financial or non-financial interests to disclose. Ethical Approval: All animal experiments were performed after obtaining necessary approvals from the Institutional Animal Ethics Committee (IAEC). Maintenance (housing and care) of all animals (mice, rats & rabbits) involved in the study was adhered to guidelines of the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA, 2003). All studies were performed following both national and international guidelines in compliance with OECD (Organization for Economic Co-operation and Development) Principles of Good Laboratory Practice (1997)(“OECD Guidelines for Testing of Chemicals, Section 4, No. 471: ‘Bacterial Reverse Mutation Test’, adopted July 21st, 1997,” n.d.).

Details

ISSN :
15565068
Database :
OpenAIRE
Journal :
SSRN Electronic Journal
Accession number :
edsair.doi...........83f95aa52a727a5c9154a70e1053b6d1
Full Text :
https://doi.org/10.2139/ssrn.3737812