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Stability study of a recombinant protein based on Plasmodium vivax circumsporozoite protein candidate for malaria vaccine

Grant number: 18/25993-6
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Effective date (Start): March 01, 2019
Effective date (End): January 18, 2022
Field of knowledge:Biological Sciences - Parasitology - Protozoology of Parasites
Principal Investigator:Irene da Silva Soares
Grantee:Janaína Tenorio Novais
Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Malaria is a serious public health problem worldwide, causing in 2016 about 216 million cases of the disease, mostly concentrated in the tropical Africa region. In Brazil, malaria cases are also alarming, with approximately 200 thousand cases registered in 2017, of which 85% were caused by the species Plasmodium vivax. The main goal of our research group is the development of a recombinant vaccine based on the Circumsporozoite Protein of P. vivax (PvCSP). Recently, we demonstrated that a formulation of the chimeric yPvCSPAllCT, based on CSP of P. vivax, induced high titers of long-lasting antibodies, as well as protective effect in immunized mice, indicating great potential to be submitted to pre-clinical trials and, later, clinical trials (GIMENEZ et al., 2017). Based on these results, it was therefore necessary to evaluate the stability of the vaccine formulation, since this type of study is essential during the development stages of a product. The results obtained will support the best strategy to be adopted in the formulation to be used in future preclinical and clinical trials. Thus, the goal is the expression and purification of the chimeric protein yPvCSP-AllCT, and evaluation of the formulation stability through tests such as gel electrophoresis, immunoblotting, circular dichroism, HPLC, pH and ELISA, at 3 different storage temperatures, and in two different liquid and lyophilized dosage forms. In the future, these data will be valuable in establishing the most stable pharmaceutical form of a possible malaria vaccine caused by P. vivax.

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