Determination of reactogenicity and allergenicity of the immunobiological drug for prevention and treatment of candidiasis

Abstract

It is known that the use of drugs, which are capable to stimulate a protective immune response against candidal infection, i.e. immunobiological drugs stimulating protective functions, is a promising direction in the fight against candidiasis. The aim of this work was to study reactogenicity and allergenicity of a new immunobiological drug based on the antigens of C. albicans and C. tropicalis fungi. The study of reactogenicity and allergenicity of the solution of the immunobiological drug for prevention and treatment of candidal infection was carried out in healthy guinea pigs weighing 300-400 g; there were 3 animals in the control and experimental groups each. The experimental animals were dehaired on the sides. To determine reactogenicity the solution of the immunobiological drug in the volume of 0.2 ml was injected intradermally on one side of the body. To determine allergenicity the immunobiological drug in the volume of 0.2 ml was injected intradermally to the experimental animals three times at 14 days intervals, and in 14 days after the last injection the immunobiological drug in the volume of 0.2 ml was injected intradermally to guinea pigs. The animals of the control group were injected with the sterile 0.9% isotonic saline solution. Observations for the presence of local reactions occurrence at the site of injection of the immunobiological drug were performed the first 5 minutes and every 2 hours for 24 hours. As a result of the research conducted it has been found that the immunobiological drug based on the antigens of fungi of C. albicans with the protein concentration of 3 mg/ml and C. tropicalis with the protein concentration of 5 mg/ml in the ratio of 1:1 for prevention and treatment of candidal infection is not reactogenic and allergenic. Fungi of Candida genus are the most widespread causative agents of fungal infections. They can cause both minor skin lesions and mucous membranes, as well as very serious diseases of almost all organs of the body [1]. Such wide range of infections requires a significant range of diagnostic and therapeutic strategies. It is known that the use of vaccines for treating candidiasis is considered to be a promising direction. Such studies are carried out actively both on the territory of the former Soviet Union, and in Europe and America [4, 7, 8]. Development of subunit combined vaccines is a priority area [2, 5, 6]. It should be noted that currently no domestic vaccine is produced in Ukraine and no imported vaccines have been registered. Therefore, development of a vaccine against candidiasis is the topical issue of modern pharmacy and medicine. According to our previous studies the immunobiological drug developed at the National University of Pharmacy and based on the associated antigens of fungi of C. albicans with the protein concentration of 3 mg/ml and C. tropicalis with the protein concentration of 5 mg/ml in the ratio of 1:1 is capable of providing the prophylactic and therapeutic effect with two intramuscular injections in the volume of 0.2 ml [9, 10].