In vitro immunogenicity and safety evaluation platform for viral vaccines - rabies vaccine

• Grant number: 24/17936-3
• Support Opportunities: Regular Research Grants
• Start date: July 01, 2025
• End date: June 30, 2027
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Wagner Quintilio
• Grantee: Wagner Quintilio
• Host Institution: Instituto Butantan. Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Durvanei Augusto Maria ; Josana Kapronezai ; Regina Maria Mourão Fuches ; Soraia Attie Calil Jorge ; Thaissa Consoni Bernardino

Abstract

The emergence of the SARS-CoV-2 virus at the end of 2019 and the ensuing pandemic marked an inflection point in vaccine development strategies and other immunobiologicals. It became evident that there is a need to be prepared for emerging diseases with ready-to-deploy development platforms to combat emerging or re-emerging diseases.Immunogenicity and safety trials for immunobiologicals are still conducted in vivo, despite all the negative aspects of this approach (from model deficiencies to ethical concerns related to animal suffering).The proposal aims to study the implementation of an alternative platform for in vitro immunogenicity studies, using human immune system cells and immunoenzymatic assays such as ELISA or ELISPOT to characterize the potential of vaccine candidates before in vivo trials. This represents a more assertive strategy with the primary goal of reducing the number of animals used to develop an immunobiological.From a product safety perspective, the proposal aims to implement organoid technology of hepatic cells or even organ-on-a-chip technology for potential toxicity studies of the formulations. These in vitro studies will allow for additional characterization of the biological candidate products, which may provide greater support for formulation development.Considering the needs, we propose the use of rabies vaccine as a model for these studies, focusing on vaccine candidates based on virus-like particle (VLP) technology produced in insect cells, or even mRNA formulations in lipid nanoparticles, following strategies already in development at the Laboratory of Viral Biotechnology. (AU)