"Immunobiological Production Center - Rabies Vaccine (CePI - Rabies)"

• Grant number: 24/01094-3
• Support Opportunities: Research Grants - Science Centers for Development
• Start date: July 01, 2024
• End date: June 30, 2029
• Field of knowledge: Biological Sciences - Immunology - Applied Immunology
• Principal Investigator: Esper Georges Kallás
• Grantee: Esper Georges Kallás
• Host Institution: Instituto Butantan. Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Pesquisadores principais: Milena Apetito Akamatsu ; Patricia Antonia Estima Abreu de Aniz
• Associated researchers: Ana Marisa Chudzinski-Tavassi ; Andrea de Cassia Rodrigues da Silva ; Carla Cristina Squaiella ; Daniela Cajado de Oliveira Souza Carvalho ; Débora Botéquio Moretti ; Denise Vilarinho Tambourgi ; Durvanei Augusto Maria ; Fabiana Lauretti Ferreira ; Fernanda Castro Boulos ; Fernanda Faria ; Gisele Picolo ; Giselle Pidde Marques Porto ; Giuliana Gaggini Rondon ; Isadora Maria Villas Boas Silva ; Jamile Ramos da Silva ; Karin Corrêa Scheffer Ferreira ; Luciana Botelho Chaves ; Marcelo de Franco ; Maria Carolina Quartim Barbosa Elias Sabbaga ; Mauricio Barbugiani Goldfeder ; Neuza Maria Frazatti Gallina ; Raul Machado Neto ; Regina Maria Mourão Fuches ; Regis Edgar Castilho Junior ; Ricardo das Neves Oliveira ; Sandra Coccuzzo Sampaio Vessoni ; Soraia Attie Calil Jorge ; Wagner Quintilio ; Wesley Luzetti Fotoran
• Associated scholarship(s): 25/09649-7 - Development of Rabies Vaccine Production for Human Use - A Study on the Scaling of Rabies Virus Production in Bioreactors., BP.TT; 25/09775-2 - Development of rabies vaccine production for human use - Establishment of in-process control trials., BP.TT; 25/09776-9 - Development of rabies vaccine production for human use - Development of in vitro potency test, BP.TT; 25/09650-5 - Development of rabies vaccine production for human use - Study of the downstream stages of rabies virus production., BP.TT

Abstract

Rabies occurs in more than 150 countries, causing 59,000 human deaths every year. It is a viral disease that, without proper treatment, leads to death in almost 100% of cases within a short period. The estimated demand for the rabies vaccine is around 64 million doses and globally, rabies causes an estimated cost of US$8.6 billion per year. Of the 24 rabies vaccine manufacturers registered until 2020, only four have their production pre-qualified by the World Health Organization. Currently, there is no production of the Active Pharmaceutical Ingredient (API) for the formulation of the human rabies vaccine in Brazil. Therefore, this proposal to create the 'Immunobiological Production Center - Rabies Vaccine' (CePI - Raiva, acronym in Brazilian Portuguese) aims at the production, improvement and self-sufficiency of rabies vaccines under Good Production Practices for human use, seeking future supply to the Brazilian National Immunization Program for distribution and use in the Brazilian population through our public health system. To do so, the Site will focus on two main activities: 1) Resuming API production of the rabies vaccine and improving the inactivated virus vaccine; 2) Developing new rabies vaccines. In relation to item 1, the Site will resume and update the production process of the inactivated virus vaccine in light of new existing technologies, such as the use of 'single-use' systems. These process changes should be included in Instituto Butantan's (IBu) rabies vaccine registry, enabling a swift distribution to the Brazilian population. The group also intends to improve vaccine production and develop a more stable inactivated virus vaccine, e.g. frozen and/or freeze-dried ones. These new presentations offer important alternatives when setting strategies of vaccine distribution to the population, allowing distribution to urban areas that are well-structured in terms of their cold chain and to the most remote areas of the country that do not have such infrastructure. Regarding the development of new rabies vaccines, item 2, the Site intends to develop and produce an adjuvanted vaccine using the IB160 adjuvant produced at IBu for phase 1/2 clinical trials, aiming to increase the immune response and/or production capacity, to meet the demand currently dependent on production outside the country. It also intends to establish an mRNA vaccine platform with a rabies model, offering an alternative rabies vaccine while mastering a new platform that can be easily adapted for the development of new vaccines in the short term. Preliminary results of these initiatives are described in item IV of the Research Plan. By resuming API production and improving and developing new rabies vaccines in Brazil, CePI-Raiva aims to solve a national public health issue, achieve self-sufficiency in this biologic and, in the future, assist developing countries by shipping its surplus production. (AU)