Group for Advanced Development - Zika Vaccine (GDA-Zika)

• Grant number: 24/00880-5
• Support Opportunities: Research Grants - Science Centers for Development
• Start date: July 01, 2024
• End date: June 30, 2029
• Field of knowledge: Biological Sciences - Microbiology - Applied Microbiology
• Principal Investigator: Renato Mancini Astray
• Grantee: Renato Mancini Astray
• Host Institution: Instituto Butantan. Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Pesquisadores principais: Cássia Gisele Terrassani Silveira ; Eutimio Gustavo Fernández Núñez ; José Alfredo de Sousa Moreira ; Viviane Fongaro Botosso
• Associated researchers: Ana Marisa Chudzinski-Tavassi ; Ana Priscila Perini de Araújo ; Andreza Rodrigues Ueoka ; Carla Lilian de Agostini Utescher ; Denise Cristina Andre Oliveira ; Durvanei Augusto Maria ; Esper Georges Kallás ; Flávia Ferreira Barbosa ; Josana Kapronezai ; Marcia Carvalho de Abreu Fantini ; Monica Beatriz Mathor ; Renata Nascimento Gomes ; Soraia Attie Calil Jorge

Abstract

The 21st century is being marked by the occurrence of climate change and the emergence of new infectious diseases. Viruses previously restricted to their natural ecosystems have come into contact with the human population, causing epidemics and pandemics. In one of these incidents, Brazil was affected by the mass transmission of Zika virus from the same vector that transmits other arboviruses. The Zika epidemic caused a variety of malformations in newborns, being called congenital Zika virus syndrome. The Brazilian scientific community made several advances at the time of the epidemic, but we did not find a solution for the effective prevention of likely new outbreaks. The Butantan Institute's proposal since the beginning of the outbreak has developed a Zika vaccine with national technology. To this end, many basic research steps were carried out for the production of Zika virus, inactivation and its presentation in the form of a vaccine prototype. This preparation has been shown to be immunogenic, generating neutralizing antibodies in laboratory animals. Currently, the prototype requires the completion of its development on bench and pilot scale, pre-clinical trials and batch production under conditions of good manufacturing practices (GMP) to be accessible to combat the disease. Development still has scientific challenges to be overcome, such as: improving processes; proposition, construction and testing of analytical methods; study of the best composition of the already established base formulation; determination of dose and vaccination schedule; in-depth description of the immune response provoked by the vaccine. With regard to development, product planning, using the concepts of planned quality or Quality by Design, is at the heart of the project, as records will be the basis for consistent production of batches for pre-clinical trials and subsequent transfer of technology for the GMP areas and production of the experimental product. The project is built on the premise of engaging various areas of the institution, through representatives focused on the product, forming the Advanced Development Group. This group will work together at various stages of development, seeking to identify problems or needs from the project to the prototype, following the best international examples of research and development centers focused on obtaining scientifically based products. (AU)