Investigation of elements induced by the vaccine response in individuals submitted to clinical tests with the ChAdOx1 nCOV-19 vaccine

This research proposal consists of an unfolding of the international project with samples of volunteers for testing the Oxford-UNIFESP ChAdOx1 nCoV-19 vaccine. The proposal will involve the 2,000 samples of volunteers, and the corresponding periods, to establish mainly a repository for the entire academic community of the State of São Paulo. This repository will be converted into a biobank after the completion of the project, as stated in the current legislation. In addition, the samples stored in the biorepository will be used to perform analyzes of these samples that do not overlap with the "Primary and secondary outcome measures", as described in the clinical trial documentation available at ClinicalTrials.gov (National Institutes of Health, ID NCT04400838) . The project will be coordinated by Prof. Luiz Mario Ramos Janini and will include a team of leading researchers in different areas, referring to the specific objectives and research history of FAPESP. The objectives of this project are: (1) to establish a biorepository containing all samples obtained from volunteers before and after vaccination. This biorepository will be available, in accordance with legal procedures, for the entire scientific community of the State of São Paulo, as determined by FAPESP guidelines; (2) to evaluate the neutralization capacity of sera of individuals vaccinated against SARS-CoV-2 strains specific to Brazil and other specific strains of coronavirus to assess cross-immunity; (3) to characterize Brazilian SARS-CoV-2 isolates and to study the sequence variation and evolutionary patterns of the protein "Spike" specific to assess the escape potential of the vaccine by modifying the target or epitopes; (4) generate and analyze serum cytokine profiles of volunteers before and after vaccination to assess the inflammatory response and associated effects; (5) analyze and compare the blood transcriptomes of volunteers, by RNA-seq, before and after vaccination. This analysis will be quantitative and qualitative to assess the impact of the vaccine on differential levels of gene expression and to assess individual variation in the genetic response to the vaccine and (6) to analyze the secretomeome profile in the volunteers' whole blood, before and after vaccination, to evaluate the type of immune response predominant and possible "priming" by another coronavirus. (AU) (4) generate and analyze serum cytokine profiles of volunteers before and after vaccination to assess the inflammatory response and associated effects; (5) analyze and compare the blood transcriptomes of volunteers, by RNA-seq, before and after vaccination. This analysis will be quantitative and qualitative to assess the impact of the vaccine on differential levels of gene expression and to assess individual variation in the genetic response to the vaccine and (6) to analyze the secretomeome profile in the volunteers' whole blood, before and after vaccination, to evaluate the type of immune response predominant and possible "priming" by another coronavirus. (AU) (4) generate and analyze serum cytokine profiles of volunteers before and after vaccination to assess the inflammatory response and associated effects; (5) analyze and compare the blood transcriptomes of volunteers, by RNA-seq, before and after vaccination. This analysis will be quantitative and qualitative to assess the impact of the vaccine on differential levels of gene expression and to assess individual variation in the genetic response to the vaccine and (6) to analyze the secretomeome profile in the volunteers' whole blood, before and after vaccination, to evaluate the type of immune response predominant and possible "priming" by another coronavirus. (AU) by RNA-seq, before and after vaccination. This analysis will be quantitative and qualitative to assess the impact of the vaccine on differential levels of gene expression and to assess individual variation in the genetic response to the vaccine and (6) to analyze the secretomeome profile in the volunteers' whole blood, before and after vaccination, to evaluate the type of immune response predominant and possible "priming" by another coronavirus. (AU) by RNA-seq, before and after vaccination. This analysis will be quantitative and qualitative to assess the impact of the vaccine on differential levels of gene expression and to assess individual variation in the genetic response to the vaccine and (6) to analyze the secretomeome profile in the volunteers' whole blood, before and after vaccination, to evaluate the type of immune response predominant and possible "priming" by another coronavirus. (AU) by another coronavirus. (AU) by another coronavirus. (AU)