Aim: Study experimental production series of Staphylovac-2 by accumulation of specific IgG and safety.
Materials and methods: Experimental production samples of staphylococci vaccines were studied by the accumulation of specific IgG in sera of immunized BALB/c line mice in EIA. Safety was evaluated in tests of acute and chronic toxicity including pathomorphologic and histologic, hematologic and biochemical studies, studies of the effect on central nervous system.
Results: A statistically significant (2.6 - 3.0 times) increase of IgG levels in sera of immunized mice compared with control was noted. In the experiments studying acute and chronic toxicity the increase in body mass and mass of internal organs differed from data obtained from control animals at no observation periods. None of the studied methods of safety evaluation showed differences of the studied vaccine series from the control.
Conclusion: The recommended dose for subcutaneous administration into human of 200 μg is experimentally justified and could be the basis for carrying out clinical studies of staphylococci vaccines in humans.