The aim of this preclinical study is to evaluate the safety of StreptInCor, a candidate vaccine to prevent S. pyogenes infections. A dose of 200 μg/500 μL of StreptInCor onto aluminum hydroxide and placebo (prepared under GMP condition) were used in this study. The repeated-dose toxicity studies in mini pigs were performed by a certified and independent company (Tecam Laboratórios). An additional non-manipulated group was included. All animals were submitted to echocardiogram examination before immunization and after the four doses treatment (28 days). Systolic function, mitral and aortic valves and cardiac blood flow were observed by a veterinarian and a cardiologist. The images obtained showed no significant changes. In addition, no macroscopic and microscopic alterations of heart and its valves in the animals from any group were observed. These results indicate that StreptInCor is a safe and promising candidate vaccine against S. pyogenes infections and therefore it will allow the conduction of a phase I/IIa clinical trial.
Financial Support: Conselho Nacional de Desenvolvimento e Pesquisa (CNPq), Banco Nacional de Desenvolvimento Econômico e Social (BNDES), Instituto Nacional de Ciência e Tecnologia de Investigação em Imunologia (INCT-iii)