Covid 19: Evaluate Immunogenicity and Efficacy of Recombinant SARS-CoV2 Protein Vaccine in a Pre-Clinical Mouse Model

Title: Biological activity testing of candidate SARS-CoV2 vaccine Performance Site and Location: Siva K Gandhapudi, PhD Scientist IV Department of Microbiology, Immunology, and Molecular Genetics UK Medical Center MN 421 Lexington KY, USA 40536-0298 IUCAUC Protocol Number: 2019-3226 These studies will be performed in Jerold G. Woodward lab and under the Supervision of Dr. Gandhapudi and Jerold G.Woodward. The studies will be designed by the Farmacore Biotechnology Ltd., located at the University of University of São Paulo. The Farmacore Biotechnology Ltd. (Farmacore) is a clinical phase biotechnology company, which operates from the university of University of São Paulo. Farmacore in partnership with PDS biotechnology (PDS) recently developed a proprietary cationic lipid and recombinant protein based Vaccine against SARS-COV2. Prior to use in human clinical trials, Farmacore intends to demonstrate the biological activity of their candidate SARS-CoV2 vaccine in pre-clinical mouse models. Proposed Scope of Work: A total of one study will be performed to evaluate the biological activity of the manufactured SARS-CoV2 candidate vaccine. Study 1: ELISPOT Validation Study: In this study, Dr. Gandhapudi will perform experiments to measure antigen- specific Immune responses generated by the vaccine. Each experiment will involve injecting groups of mice with the candidate vaccine on day 0 and day 28. 28 days after the second vaccination, mice will be euthanized, and the harvested spleens will be assessed for vaccine-induced T cell response using a commercially available mouse IFN- gamma, and IL-4 Elispot kits. The Elispot validation will be used to assess the biological activity and efficacy of the vaccine. Study 2: Measure Vaccine specific Antibody responses: In this study, Dr. Gandhapudi will collect blood on day 28, and on day 56 from mice vaccinated with prototype SARS-CoV2 vaccine and measure antigen specific antbody titers in the plasma. Each experiment will involve injecting groups of mice with the candidate vaccine on day 0 and day 28. Blood will be collected from vaccinated mice on day 28 and on day 56 after the first vaccination. Blood will be processed to isolate serum. Serum samples will then be analzed for the presence of vaccine specific antibodies. The antibody titers will be used to measure the vaccine potency in mouse models. Study 3: Test the neutralining of SARS-CoV2 vaccine induced antibodies: In this study, Dr. Gandhapudi will perform experiments to measure neutralizing activitity of vaccine induced antibodies. For this study, the serum samples obtained from the study 2 will be used. In this experiments, human cell lines that can be infected with SARS-CoV2 spike protein expressing pseudovirus will be exposed to the pseudovirus in presence of serum from the vaccinated mice. The ability of serum in blocking pseudovirus infection of human cell line will be measured using fluroscense assay. This signal will then be used to assess the biological efficacy of the candidate vaccine. Estimated budget: The proposed study will be performed in the 4-month period, July to November 2020. The estimated budget for the proposed studies is: personnel $ 5,850.00 Supplies and animals $ 34,920.00 Direct Cost total $ 40,770.00 F&A costs (34%) $ 13,862.00 Total costs $ 54,632.00