Abstract:Background & objectives:
The global pandemic caused by SARS-CoV-2 virus has challenged public health system worldwide due to the unavailability of approved preventive and therapeutic options. Identification of neutralizing antibodies (NAb) and understanding their role is important. However, the data on kinetics of NAb response among COVID-19 patients are unclear. To understand the NAb response in COVID-19 patients, we compared the findings of microneutralization test (MNT) and plaque reduction neu… Show more
“…The virus–serum mixtures were added onto the preformed Vero CCL-81 cell monolayers and incubated 1 h at 37°C in a 5% CO 2 incubator. The number of plaques was counted, and the Neutralizing antibody titer was determined based on the 90% reduction in the number of plaque count, which was further analyzed using 50% ProbitAnalysis 38 . A neutralization antibody titer < 1:20 considered negative, while that of > 1:20 considered as positive.…”
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 virus–serum mixtures were added onto the preformed Vero CCL-81 cell monolayers and incubated 1 h at 37°C in a 5% CO 2 incubator. The number of plaques was counted, and the Neutralizing antibody titer was determined based on the 90% reduction in the number of plaque count, which was further analyzed using 50% ProbitAnalysis 38 . A neutralization antibody titer < 1:20 considered negative, while that of > 1:20 considered as positive.…”
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 sero-conversion rate with neutralizing antibodies (NAb) following vaccination with BBV152 was 99.6%. 5 Here, we present the NAb titers (PRNT 50 ) to underline the efficacy of BBV152 vaccine candidate against SARS-CoV-2 UK-variant and one of the heterologous strains hCoV-19/India/2020Q111 (unclassified cluster) 6 . Sera collected from 38 vaccine recipients, who received BBV152 vaccine-candidate in phase-II trial4 had equivalent NAb titers to hCoV-19/India/2020770 homologous strain and two heterologous strains with the characteristic N501Y substitution of the UK-variant; hCoV-19/India/20203522 (UK strain) as well as hCoV-19/India/2020Q111 (Figure 1 A and B).…”
We performed the plaque reduction neutralization test (PRNT50) using sera collected from the recipients of BBV152/COVAXIN™ against hCoV-19/India/20203522 (UK-variant) and hCoV27 19/India/2020Q111 (heterologous strain). A comparable neutralization activity of the vaccinated individuals sera showed against UK-variant and the heterologous strain with similar efficiency, dispel the uncertainty of possible neutralization escape.
“…Plaque reduction neutralization test (PRNT): PRNT was performed as described by Deshpande et al, (2020) 17 . Brie y, four-fold serial dilutions of heat inactivated (56°C for 1 h) horse plasma samples were mixed with an equal amount of virus suspension containing 50-60 plaque forming units (pfu) in 0.1 ml.…”
The pandemic of COVID -19 caused by SARS-CoV-2 is leading to a humongous impact on the mankind with over a million people succumbing to it worldwide. Although there are few drugs approved for the treatment, there is not yet a safe and effective vaccine available for COVID-19. Also, the passive immunization therapy with convalescent plasma, though potentially an effective treatment option for other viral disease has limitation of availability. The prior use of immunoglobulins generated in animals has proven to be effective in several viral and bacterial diseases. Here, we report the development and evaluation of equine hyper immune globulin raised against inactivated SARS-CoV-2 virus. Post immunization neutralization titres of the equines demonstrated high neutralizing antibodies. To minimize the adverse effects, the immunoglobulins were digested with pepsin, and purified to obtain the F(ab’)2 fragments. The average nAb titre of the purified bulk was 22,927 and correlated with high IgG binding efficiency in ELISA. The quality control assessments of the different batches proved to have consistent nAb titres. The study provides evidence of the potential of generating highly purified F(ab’)2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralization activity. Further, in-vivo testing for efficacy of this indigenously developed, cost effective product will pave the way to clinical evaluation.
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