Efficacy, safety and immunogenicity of a trivalent inactivated split influenza vaccine in patients with rheumatic diseases

Abstract

The aim of the study was to study the efficacy, safety and immunogenicity of trivalent split influenza vaccine in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic scleroderma (SSD). Material and methods. Ninety three patients were enrolled in the study, including 52 patients with RA, 34 with AS, 7 with SSD, and also 40 persons without rheumatic diseases (RD) (control group). At the time of enrolment, all patients received RD drug therapy. The duration of RD was from 2 months up to 46 years. Vaxigrip vaccine, which included the actual strains of influenza virus for the 2016-2017 or 2017-2018 seasons was administered subcutaneously in the amount of 1 dose (0.5 ml) against the backdrop of continuing RD therapy. The main stages of control were visits at 1-, 3- and 6-month intervals after vaccination. Standard clinical and laboratory tests, a clinical examination of the patient and assessment of disease activity were performed during the visits. Immunogenicity of the vaccine was evaluated at each stage of the control procedure using the commercial ELISA kits manufactured by PPDP LLC (St. Petersburg). Results. No cases of influenza or influenza-like illness were recorded during the entire period of observation. 81% of patients had no post-vaccination reactions in the RD group. Pain, swelling and hyperaemia of the skin with a diameter of up to 2 cm at the injection site were reported in 14% of cases and subfebrility, myalgia, malaise, headache in 5% of cases. The frequency of postvaccinal reactions among patients was not significantly different from that in the control group. There were no cases of exacerbation of RD or the occurrence of any new autoimmune disorders. The parameters of the humoral immune response in patients with RD did not significantly differ from those in the control group. Conclusion. The obtained data testify about good clinical efficacy and tolerability of trivalent split influenza vaccine in patients with RD.