Background. The vaccine is the best available instrument to prevent influenza and reduce the risks of major disease complications and mortality. The vaccine effectiveness during the influenza season depends on a number of factors: (1) a person vaccinated (their age and health status); (2) the vaccine formulation; (3) types and subtypes of the circulating viruses; (4) vaccination timeline, as the immune response fades over time. An influenza vaccine can yield different effectiveness in people who have been infected or vaccinated previously and in those who have not been yet exposed to the circulating viruses. At present, trivalent and quadrivalent influenza vaccines are registered and produced in Russia. It allows for vaccination of all social groups, including high-risk populations, and for increasing the number of vaccinated individuals yearly. Russian Federation constantly improves the production of influenza vaccines, introducing new variants of vaccine formulations into national clinical usage. It is thus essential to monitor and analyze the changes in the effectiveness of influenza vaccines every season.Aim of the study. To evaluate of the effectiveness of Russian domestic influenza vaccines during the epidemic season 2019–2020 in St. Petersburg compared to the season 2018–2019.Materials and Methods. 3315 female and male adult participants aged 18 years and older were monitored from October 2019 to March 2020. The group included university students and tutors, researchers, and production and office workers of industrial enterprises. Sovigripp, Grippol Plus, Ultrix, and Ultrix Quadri influenza vaccines were used for immunization.Results and Discussion. In the context of incomplete correspondence between the viruses circulating in Russia and the strains used in the vaccines, the vaccination of the St. Petersburg population during the epidemic season 2019-2020 with Sovigripp, Grippol Plus, Ultrix, and Ultrix Quadri influenza vaccines cumulatively reduced influenza and ARI incidences by half; the total vaccine effectiveness against influenza and ARI amounted to 50.0%. The strongest preventive effect was identified for Grippol Plus, Ultrix, and Ultrix Quadri which demonstrated the total vaccine effectiveness from 70.6% to 75.0%, and their effectiveness against influenza A and B viruses reached from 65.5% to 83.5%.Conclusion. In the context of incomplete correspondence between the viral strains used in the vaccines and the strains circulating in Russia and St. Petersburg during the epidemic season 2019- 2020 and considering the active circulation of non-influenza viruses such as rhinoviruses and adenoviruses, we found a moderate preventive effectiveness of the influenza vaccines during the seasonal epidemic increase in ARI cases. Russian domestic influenza vaccines were shown to have good acceptability, be safe, and non-reactogenic.

Background. The influenza vaccination coverage has steadily increased in the Russian Federation. The introduction of new domestic influenza vaccines into practice and the study of their effectiveness are of great importance for public health. However, a systematic analysis of the effectiveness of vaccines manufactured and used in Russia in recent years has not been performed. The aim ofthe study was to assess the epidemiological effectiveness of three domestic influenza vaccines in St. Petersburg during the 2018–2019 epidemic season.Material and methods. The organized community of 1892 young students aged 18 to 23 years has been under supervision during the period of time from October 2018 to March 2019. Influenza vaccines Grippol Plus, Sovigripp, and Ultrix were used for vaccination.Results and discussion. Prophylactic vaccination with influenza vaccines Sovigripp, Grippol Plus and Ultrix in the fall of 2018 led to a decrease in the incidence of influenza and other acute respiratory infections (ARI) by a total of 1.6–3.8 times; a decrease in the incidence of influenza by 2.7–7.1 times; the total protective efficacy of vaccines against influenza and ARI was 52.4%, and against influenza, taking into account laboratory correction, 73.3%.Conclusions. Under the conditions of the viruses circulating in Russia and in St. Petersburg in the 2018–2019 epidemic season the strains introduced into the composition of influenza vaccines, domestic influenza vaccines were characterized by good tolerance, were safe, areactogenic and had a pronounced protective effect. If the viruses circulating in Russia and in St. Petersburg in the 2018–2019 epidemic season corresponded to the strains introduced into the composition of influenza vaccines, domestic influenza vaccines, showing good tolerance, safety and low reactogenicity, had a pronounced protective effect.

Influenza vaccination is the most strategically justifiable way to protect against influenza which allows toprevent influenza infection and its serious complications, as well as mitigate the impact of influenza epidemics. The main challenge in the fight against influenza is that influenza vaccine needs to be renewed annually due to year-to-year variability of influenza viruses. In recent years, the idea of a single vaccine against all A subtypes of the influenza virus has been actively studied.

Pregnant women are at high risk for the adverse course of respiratory diseases, among which the influenza is the one of the leading infections, of ten finishing tragically for most pregnant and her offspring. Due to the disproportionately high morbidity, mortality and adverse outcomes of pregnancy after influenza virus infection, pregnant females are classified as a priority group for vaccination. Immunization with inactivated influenza vaccine is one of the most important strategy to prevent both of influenza infection, its severe complications, and mitigating of the effects of the epidemic of influenza. There was accumulated sufficient evidence demonstrating that the vaccine promotes the diminution of clinical manifestations of influenza infection in pregnant women, as well, has a positive effect on the health of the newborns due to the active transport of maternal antibodies. In the review there are presented data on the safety, high immunogenicity and clinical efficacy of vaccination against influenza as for pregnant women as well for infants.

Currently, application of new technological solutions for the implementation of strategies for improving influenza vaccines are up to date and modern. In this study, we present data obtained in the evaluation of the safety and immunogenicity of the new Russian (national) split seasonal inactivated influenza vaccine ULTRIKS in comparison with a commercial vaccine VAXIGRIP in various age groups.

The early diagnostic of German measles infection, especially in cases requiring differential diagnostic search, the most informative and usable in practice test-systems are needed to be applied. The sampling of patients (n=37) included males aged from 15 to 21 year (average age 18 years) were admitted to hospital on 1-3 day from onset of disease. The technique of polymerase chain reaction with reverse transcription was applied to detect presence of viral RNA in nasopharyngital smear. The presence of viral RNA was confirmed in 26 examined patients (70%). The serological markers of onset of disease at the moment of first examination had 24 (65%) out of 37 patients. It is demonstrated that technique of polymerase chain reaction with reverse transcription has the most diagnostic value in confirmation of diagnosis of German measles infection at the first days of disease. In the sequel, the informativeness of methods of serological diagnostic will increase because complex application of methods of IgM and polymerase chain reaction with reverse transcription are needed at different periods of disease.

Abstract. Evaluation of reactogenicity, safety and immunogenicity of the inactivated subunit influenza vaccine adsorbed monovalent (Pandeflu) on the base of strain A/California/7/2009 (H1N1v) was conducted in 70 volunteers aged 18–60 years immunized by one or two doses. A clinical trial of the vaccine Pandeflu was conducted in the St.Petersburg Institute of Influenza. The study group included 38 women (54,3%) and 32 men (45,7%). The average age of women was 38.2 years, men — 26.9 years, mean age of all volunteers was equal to 31.7 years. This group of volunteers was randomized in 2 subgroups. The first subgroup of 50 volunteers was vaccinated with Pandeflu, but the second one of 20 volunteers was given a placebo. The strong and moderate local and systemic reactions were not observed. All local (6 volunteers) and systemic (6 volunteers) reactions were recorded after ithout any medical care. It proves the good tolerability and low reactogenicity of vaccine Pandeflu. Indicators of clinical and biochemical blood tests, a general analysis of urine during the study period were within normal limits. In the study of the immunogenicity it has been shown that after a single injection of vaccine the first vaccination. All these reactions were mild and transient and disappeared wPandeflu the seroconversion rate reached 68%, but the level of seroprotection was 52%. The multiplication factor of the geometric mean antibody titer increase in serum reached a value of 5.8. Conducting of immunization with two doses of vaccine with the interval of 28 days increases the immunogenicity: the level of seroconversion rate increases up to 96%, but the level of seroprotection – up to 74%, seroconversion factor – up to 10.8. These data confirm high immunogenic potential vaccine in case of single dose as well as double doses administration.

The early diagnostic of German measles infection, especially in cases requiring differential diagnostic search, the most informative and usable in practice test-systems are needed to be applied. The sampling of patients (n = 37) included males aged from 15 to 21 year (average age - 18 years) were admitted to hospital on 1-3 day from onset of disease. The technique of polymerase chain reaction with reverse transcription was applied to detect presence of viral RNA in nasopharyngital smear. The presence of viral RNA was confirmed in 26 examined patients (70%). The serological markers of onset of disease at the moment of first examination had 24 (65%) out of 37 patients. It is demonstrated that technique of polymerase chain reaction with reverse transcription has the most diagnostic value in confirmation of diagnosis of German measles infection at the first days of disease. In the sequel, the informativeness of methods of serological diagnostic will increase because complex application of methods of IgM and polymerase chain reaction with reverse transcription are needed at different periods of disease.

Summary. A randomized double-blind placebo controlled trial of efficacy and safety of Ingavirin (capsules, 90 mg, Valenta Pharm, Russia) administered for urgent intrafocal prevention of the disease during breaks of influenza and other acute respiratory viral infections (ARVI) in adults. The results have shown that Ingavirin is effective for intrafocal prevention of ARVI in healthy subjects in an epidemic focus. Seven-day course of the drug significantly decreased morbidity among exposed subjects by 63 % and a risk of ARVI 2.7 times; the efficacy index 2.7; relative risk 0.37. In patients developed ARVI after preventive treatment with Ingavirin, the duration of fever was 1 day shorter and the course of ARVI was milder. Ingavirin effectively prevented exposed subjects from ARVI in an epidemic focus and was active against a wide spectrum of influenza and other respiratory viruses (adenovirus, parainfluenza virus).

AIM:Assessment of reactogenicity, safety and immunogenicity after single intramuscular immunization of children with Grifor vaccine.MATERIALS AND METHODS:Reactogenicity, safety, and immunogenicity of Grifor vaccine compared with Vaxigrip vaccine was evaluated during phase III clinical trial in the Institute of Influenza. Thirty-six children aged 12 - 17 years, divided on 2 groups, participated in single blind comparative prospective randomized trial. Seroconversion factor, seroconversion and seroprotection levels were evaluated by hemagglutination inhibition assay.RESULTS:Results of study of systemic and local reactogenicity in children during first 7 days after immunization with Grifor and Vaxigrip vaccine showed good tolerability, areactogenicity and safety of both vaccines. Complete blood count, serum biochemistry and urinalysis results as well as serum IgE level did not change after vaccination. After immunization with Grifor vaccine, seroconversion rate to influenza virus subtypes A/H1N1, A/H3N2, and B was 70%, 50%, and 70% respectively, seroprotection rate--90%, 80%, and 85% respectively, and seroconversion factor--6.5, 2.7, and 4.0 respectively.CONCLUSION:This trial, which was performed in tightly controlled conditions, had demonstrated that Grifor vaccine is safe and highly immunogenic against influenza viruses A and B and satisfies criteria of both Federal Service for Surveillance for Protection of Consumers Rights and Human Welfare and CHMP of EMA. Obtained results allow to recommend the Grifor vaccine for use in pediatric practice according to national immunization schedule.

Russian enzyme immunoassay (EIA) test systems (EATS) and foreign analogues (DSL and BCM-Diagnostics, USA) were compared in the detection of human serum rubella virus (RV) antibodies. Analysis of RV IgM levels ascertained a greater agreement of quality indices for the EATS "EKOlab-Krasnukha-IgM" than for the system "VectoRubella-IgM". As compared with the USA reference systems, the sensitivity, specificity, and total agreement of the data obtained by the EATS "EKOlab" were 100, 97.5, and 97.7%, respectively; those were 88, 84.4%, and 85.4% for "VectoRubella-IgM". In healthy individuals, strictly seropositive cases of IgM detection, revealed by the EATS "VectoRubella-IgM" and unconfirmed by the results obtained by the EATS "BCM-Diagnostics-IgM" (8%) are most likely to be regarded as false-positive due to the presence of serum rheumatoid factor (RF). The principle of indirect EIA used in the system "VectoRubella-IgM" makes it impossible to rule out the impact of RF on test results. The EATS "EKOlab-Krasnukha-IgM" and the systems made in the USA apply the principle of EIA with IgM involvement that, unlike indirect EIA, minimize to have nonspecific results. All three analyzed Russian EATS "EKOlab-Krasnukha-IgG", "Krasnukha-screening", and "VectoRubella-IgG" in the detection of RV IgG show rather high diagnostic parameters as compared with the systems made in the USA. The important additional advantage of the EATS "EKOlab-Krasnukha-IgG" over other Russian systems is that the kit has reference serum with the known content of RV IgG. This allows one to give results in absolute units and to standardize the calculations of some independent experiments. The performed study suggests that out of the Russian test systems, EATS "EKOlab-Krasnukha-IgM" and "EKOlab-Krasnukha-IgG" should be preferred.