Abstract
SummaryWe 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 (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 (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-γ+ CD4+ T lymphocyte response. Our results support further development for phase I/II clinical trials in humans.
Highlights
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel human coronavirus, has spread across the world
SUMMARY We report the development and evaluation of safety and immunogenicity of a whole virion inactivated (WVI) severe acute respiratory syndrome (SARS)-CoV-2 vaccine (BBV152), adjuvanted with aluminum hydroxide gel (Algel), or TLR7/8 agonist chemisorbed Algel
Our results show that BBV152 vaccine formulations generated significantly high antigenbinding and neutralizing antibody titers (NAb), at both concentrations, in all three species with excellent safety profiles
Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel human coronavirus, has spread across the world. The World Health Organization (WHO) declared the disease caused by SARS-CoV-2 as coronavirus disease-19 (COVID-19), a pandemic in March 2020. SARS-CoV-2 has infected more than 45 million people, causing more than 1.1 million deaths (WHO Coronavirus Disease, n.d.). It is, imperative to develop effective prophylactic and therapeutic counter measures to prevent and treat COVID-19. The availability of well-characterized Vero cell manufacturing platform with proven safety have aided in rapid vaccine development of inactivated vaccines (Bhandari et al, 2014; ‘‘Global Advisory Committee (World Health Organization, 2019); Sampath et al, 2010; Singh et al, 2015; Vadrevu et al, 2020)
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