Development of a nanoparticulate liofilized multiplatform adjuvant for application in vaccines and drug delivery.

• Grant number: 24/18676-5
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2025
• End date: October 31, 2027
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Jonnatan Julival dos Santos
• Grantee: Jonnatan Julival dos Santos
• Pesquisadores principais: Marco Antonio Stephano

Abstract

As Fapesp published in its magazine in the November 2022 edition, there is a great challenge in Brazil to control and develop all stages of production of a 100% national vaccine. Although Brazil is often seen as a reference in vaccine production in institutes such as the Butantã Institute and the Oswaldo Cruz Foundation, this has not been sufficient for the size of the country and its needs, and this has become very clear in the recent Covid-19 pandemic. Even though this pandemic was atypical, it was clear that Brazil needs increase investments in disruptive technologies in the health sector. The pandemic caused by the new Corona virus (SARS-Cov-2) generated a race for vaccines, as its original strain proved to be extremely contagious and lethal. Vaccines, in general, refer to at least three components: antigen/API (active pharmaceutical ingredient), adjuvants and stabilizers. Adjuvants are compounds capable of increasing the immune response against co-inoculated antigens, but can also help stabilize antigens/API. Until the 90s, the only licensed adjuvant consisted of a compound made up of aluminum salts, known as Alum, but the development of vaccines based on RNA messenger led to new adjuvants based on synthetic lipids being introduced. Even so, we can say that two types of adjuvants are too few for the number of existing diseases, at this point we can say that we have entered a market with great opportunities by introducing a new adjuvant based on silica nanoparticles. The silica nanoparticle adjuvant presented in this project has already been used in the MultiCovax vaccine, an intranasal vaccine developed by InCor-USP (Heart Institute of the University of São Paulo), with phase I and II tests requested from Anvisa. The introduction of this adjuvant will create a new pharmaceutical product in the Brazilian vaccine market, which will initially be used in the development of a vaccine against Covid-19, but which could be applied to other vaccines. Furthermore, Brazil will emerge as the protagonist of a new class of adjuvants, since there is no report of any commercial vaccine that uses silica nanoparticles as an adjuvant. The main problems related to the reproducibility of the nanoparticle preparation method, delivery in the aquatic environment and, mainly, the production cost are already well advanced. Therefore, the aim of this project is to take a big step forward with the development of the adjuvant purification and lyophilization process, as well as the validation of its properties for application in vaccines, without losing the adjuvant effect, that is, maintaining It has the characteristic of increasing the production of antibodies. The production of a lyophilized adjuvant will imply greater stability, greater ease of transport and less loss of activity/efficacy due to weathering effects, characteristics that most current adjuvants and vaccines do not have. And above all, a 100% national product controlled by a national company, overcoming one of the biggest challenges for the national pharmaceutical industry. (AU)