We report the development and evaluation of safety and immunogenicity of a whole virion inactivated (WVI) SARS-CoV-2 vaccine (BBV152), adjuvanted with aluminium 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 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 (NAb), 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.

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.

The GSO contains 75% linoleic acid, 15% oleic acid, 6% palmitic acid, 3% stearic acid, and 1% linolenic acid. [1] Studies revealed the beneficial HDL effect of GSO and research shows that subjects were instructed to use up to 45 ml of GSO in their daily diet as a substitute for their usual oil and within 2 weeks there was 13-14% increase in HDL level. [2] The GSO has a very high level of antioxidant vitamin E (60-120 mg/100 g), which makes the oil very stable. The antioxidant property is claimed to be the mechanism of hepatoprotective activity. [3] The GSO exhibits a variety of interesting properties such as reducing platelet aggregation, prevents hypertension caused by sodium excess, normalizes lesions occurring from obesity and diabetes. [4] Among the various mechanisms involved in the hepatotoxic effect of carbontetrachloride (CCl 4), one is oxidative damage through free-radical generation [5] and antioxidant property is claimed to be one of the mechanisms of hepatoprotective effect of indigenous drugs. [6] The GSO has antioxidant properties. [2],[3] Hence, the objective of the study was to evaluate the effect of GSO on CCl 4-induced hepatotoxicity. Materials and methods Drugs and chemicals The GSO is a kind gift from LoDuca Bros Inc., Milwaukee,

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