Preclinical study of mutagenicity and safety of a vaccine against pneumococcal infection based on a recombinant hybrid protein

Abstract

Pneumococcal infection is the cause of pneumo-nia. Vaccination can prevent the severe course of this disease. The pneumococcal vaccine considered in the work was created by a genetically modified method based on a hybrid recombinant protein. The aim of the work was preclinical investigation of the mutagenic, genetic safety of the new pneumococcal vaccine, Irivax, against pneumococcal infection in rats. Materials and methods. Studies of the Irivax vaccine were carried out in male Wistar rats’ cell populations of the bone marrow and peripheral blood mononuclear cells. The karyoty-pic stability of cells and myelogram of the bone mar-row were studied. Results. After the introduction of the vaccine, the content of the lymphoid germ cells in the blood of rats was increased to 74.2% (p <0.05), which proves the body’s immune response. The frequency of cells with an unstable genome, as an indicator of the genetic safety of the AL-vaccine, was rare both in expe-rimental and control animals, and did not exceed 1.5%. Conclusion. Thus, the new pneumococcal vaccine Irivax and its components have mutagenic and toxic safety.