Детские инфекции (Москва) (Dec 2015)
New Arguments in favor of the Release Active Antiviral Drug to Prepare Children for Vaccination
Abstract
Release-active drug with a dual mechanism of action used for preimmunization against pneumococcal vaccination in children with chronic nasopharyngeal infection A prospective, randomized comparative study involving 994 children of 2 to 5 years of age was conducted (from December 2011 to April 2015) to assess the efficacy of Anaferon for Children for pre-immunization and an aid to pneumococcal vaccine treatment in children with chronic nasopharyngeal diseases. Patients in the test group (507 children) started to receive Anaferon for Children (AnC, release-active antiviral and immunomodulatory drug) 10 days prior to vaccination with a pneumococcal conjugate vaccine (PCV13) and continued the treatment for 40 days. 487 children were randomized into the comparator group receiving the PCV13 vaccine alone, without Anaferon for Children. The efficacy of Anaferon for Children was assessed by measuring the incidence of acute respiratory infections (ARI) and exacerbations of chronic ENT disease developed by study patients. In addition, total cell counts and subset ratios were obtained and activity of lysozyme and secretory immunoglobulin A was analyzed in nasal fluids. Between days 3 to 10 of study, ARI signs were reported in 58 children (11.9%) in the comparator group, thus making vaccination impossible in these subjects. In AnC group, no ARI cases were observed within the same period and all the children received the vaccine as scheduled. During the first month post vaccination, 15 cases of illness were recorded (4.9%) in the group of test treatment and 37 (7.6%) (p = 0.001) in the comparator group. The incidence rates of ARI recorded in study patients for a period of 12 months was 1686.4 per 1000 (855 infection episodes) in the test group vs. 2086.2 per 1000 (1016 ARI cases) in the comparator group (p = 0.02). Based on the data obtained over the follow-up period, patients in the test group demonstrated a 25% decrease in the incidence of ARI exacerbationsor exacerbations of chronic ENT pathology (e.g., acute otitis, acute bronchitis, pneumonia, chronic maxillary sinusitis) as compared to the comparator group (p = 0.061); the percentage of children developing no respiratory infections was increased in this group by 3 times (p = 0.001) and the number of recurrent ARI episodes was reduced by 1.2 times (p = 0.001), including a decrease of 1.6 times in the number of children with two recurrent ARI episodes (p = 0.001). AnC was noted to have a beneficial effect on lysozyme activity, sIgA level and cell count distribution in nasal fluids (normalized more rapidly compared to the comparator group). The study showed good tolerability and safety of the combination of AnC and PCV13 vaccine for the children with chronic nasopharyngeal diseases and advisability of Anaferon for children application for preparation to immunization and vaccination against pneumococcal infection.
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