[The diagnostic value of serological and molecular genetic methods in detection of German measles disease].

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.

[Clinical trial of safety and immunogenicity of new influenza vaccine Grifor in children].

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.

[Determination of the diagnostic parameters of domestic immunoenzyme test systems versus foreign analogues in the detection of serum rubella virus antibodies].

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.

[Epidemic process of rubella during mass vaccination of children].

AIM: To reveal features of rubella epidemic process during start of mass immunization and to determine rubella virus genotypes circulating in Saint-Petersburg. MATERIALS AND METHODS: Official data on rubella morbidity during 1995-2007 and number of vaccinated against rubella children and adults were used in this study. During 2006-2008 males aged 17-20 years with rubella diagnosis were eligible for laboratory test on rubella. Nasopharyngeal swabs and blood specimenswere tested by PCR and virus isolation on cell culture (PK13). Genotyping of isolates was performed on the basis of 600 nucleotide sequence of E1 gene from 8731 to 9653 n.p. RESULTS: It was shown that mass vaccination of children and young women against rubella during 4 years resulted in 3-fold drop of rubella incidence inwhole population, which diminishes the probability of infection in pregnant women and born of children with congenital rubella syndrome. In age structure of rubella morbidity the proportion of children aged 3-6 and 7-14 years decreased by 1.5-fold. Epidemic process loss the features of autoregulating system (periodicity and seasonal incidence peaks). Results of genotyping showed that isolates belonged to genotype 1E. High degree of homology (97.7-99.6%) to isolates from Barnaul and Belorussia was demonstrated. CONCLUSION: Issues on isolates' origin and success of measures on elimination of endemic rubella could be resolved by further studies on isolation and genotyping of rubella virus strains in Saint-Petersburg and North-East region of Russian Federation in the whole.

[Cycloferon, as an agent in the therapy and urgent prophylaxis of influenza and acute respiratory tract viral infection (multicentre randomized controlled comparative study)].

Data on the study of the efficacy of the tablets of cycloferon, an early inductor of types 1 and 2 interferon, in the treatment of influenza and acute respiratory tract viral infections in adults are presented. The study enrolled 522 patients with moderate influenza of type A (H1N1) verified in 61% of the patients and type A (H3N2) verified in 7.5% of the cases. The patients were randomized with the envelope procedure. In the patients treated with cycloferon the intensity and period of the fever were stopped earlier and averaged from 1.8 to 3 days vs. 5 days in the reference group (symptomatic therapy). The improvement signs in the general state of the patients treated with cycloferon were noted on the 2nd day. The influenza complication as pneumonia was recorded in 2.2% of the patients treated with cycloferon, whereas in the patients under the symptomatic therapy the complications as bronchitis, pneumonia, angina were stated in 21.4% of the cases. For urgent prophylaxis of the influenza and respiratory tract viral infections (epidemiologic study) a group of 3717 subjects randomized with the table of random numbers was observed. 2080 patients were treated with cycloferon and 1637 patients were under the symptomatic therapy. The results were evaluated by the efficacy index and the protection estimate (T. A. Semenenko, 1991). The total efficacy index and the protection estimate in all the patients of the group were 4.9 and 79.8% respectively. The complicated forms of the disease were recorded in 1.5% of the patients treated with cycloferon and in 10.5 and 11.3% of the patients not treated with cycloferon.

[Vaccine prophylaxis in elderly patients]. / O taktike vaktsinoprofilaktiki u pozhilykh liudei.

In 1997-1999 observation was made on elderly people living in old people's homes and in families, as well as groups of young males living in hostel-type homes, altogether 4,518 subjects. Standard inactivated whole-virion influenza vaccine was introduced in a dose of 0.5 ml subcutaneously in a single injection or intranasally in two administrations. In control groups placebo was used. The frequency of seroconversions to vaccine strains of influenza viruses was significantly less in elderly people than in young people following both subcutaneous and intranasal immunization (on the average, by 15-20%). In young people the prophylactic effectiveness of the vaccine introduced intranasally was the same as after subcutaneous immunization with the effectiveness index (EI) being equal to 2.1-2.8. In elderly people the effectiveness of the vaccine after subcutaneous immunization was the same as in young people (EI = 1.7-2.7), but insufficient after intranasal immunization (EI < or = 1.6). The preparation "Amber elixir plus" enhanced the effectiveness of immunization against influenza in elderly people.

[The immunoprophylaxis of influenza among elderly persons]. / Immunoprofilaktika grippa sredi liudei pozhilogo vozrasta.

During three seasons at the period of 1992-1996 immunization of elderly persons, living in homes for old people, against influenza with inactivated influenza vaccine (IIV) was carried out. Altogether 856 persons were immunized intranasally, 581 persons constituting the control group. For comparison, 4,825 healthy young adults aged 18-24 years were immunized under similar conditions. The study revealed that the intranasal immunization of elderly persons with IIV, made in two administrations, was safe and stimulated sufficient humoral and secretory immunity: the level of seroconversions was 24.3-41.0% to type A(H1N1) influenza virus, 29.6-50.7% to type A(H3N2) influenza virus, 39.3-59.6% to type B influenza virus; the level of diagnostic IgA conversions was 31-38%. Immunization produced a pronounced prophylactic effect (the effectiveness index 1.6-1.7), as well as decreased the total mortality level by half. The tactics of the immunization of persons from high risk groups against influenza in medical practice is discussed.

[The use of the radial hemolysis reaction for demonstrating antibodies to the surface antigens of the influenza virus in assessing postvaccinal immunity]. / Ispol'zovanie reaktsii radial'nogo gemoliza dlia indikatsii antitel k poverkhnostnym antigenam virusa grippa pri otsenke postvaktsinal'nogo immuniteta.

Two serological tests--single radial hemolysis (RSH) and hemagglutination inhibition (HI) were used to evaluate the different techniques (intranasal, intradermal and combined methods) of application of inactivated influenza vaccines. When seroconversion to hemagglutinin (HA) was determined sensitivity of SRH proved to be higher as compared with HI by 6.7-41.4%. This test has also shown that the frequency of the seroconversion to HA was 2.1-5.6 times higher than that to neuraminidase (NA). It is important to standardize both HA and NA components in the influenza vaccine. It is interesting to study the local and cell immunity after intranasal inoculation of influenza vaccine because of the low postvaccinal level of serum antibodies and in connection with some publications concerning the protective role of this immunization method.

[Assessment of the effectiveness of inactivated influenza vaccines for adults]. / Otsenka éffektivnosti inaktivirovannykh grippoznykh vaktsin dlia vzroslykh.

In 9 controlled epidemiological observations (1977-1984) the effectiveness of modern Soviet whole-virion vaccines was studied in organized groups of adults and at industrial enterprises. During the epidemic outbreaks of influenza of different etiology and intensity morbidity rate in influenza and acute respiratory diseases was shown to decrease 1.1-2.2 times among the vaccinees, depending on the correspondence of epidemic and vaccine influenza strains. The absence of influenza virus B in inactivated influenza vaccines was the reason for their low effectiveness during influenza outbreaks of mixed etiology B + A (H1N1).

[Results of a study of the effectiveness of simultaneous immunization against influenza with live and inactivated vaccines (1980-1983)]. / Itogi izucheniia éffektivnosti odnovremennoi immunizatsii protiv grippa zhivoi i inaktivirovannoi vaktsinami (1980-1983 gg.).

A comparative evaluation of immunological and epidemiological effectiveness of commercial live and killed vaccine preparations used simultaneously or separately was first carried out in simultaneous field trials of various methods of influenza vaccine prevention in a human population of 10,449 subjects. The advantage of simultaneous immunization was confirmed by immunological parameters and protective effect in the period of influenza A epidemic of 1983. The correlation of immunological and epidemiological effectiveness of influenza vaccines in joint or separate administration is discussed.

The system of population protection against influenza.

The complex protection of population against influenza includes: 1. annual mass vaccinoprophylaxis among unvaccinated people; 2. urgent influenza prophylaxis among unvaccinated people; 3. early treatment of influenza. Realization of this system in 1980-1984 in some cities of the USSR resulted in reduction of epidemic influenza morbidity by 20-65%, decrease of annual average influenza and acute respiratory morbidity by 15-20% of the level awaited, i.e. by 200,000 to 300,000 cases per million of citizens. However incomplete accordance of influenza vaccines composition with epidemiological situation, insufficiently wide usage of vaccines and other preparations has not allowed to prevent influenza epidemics in other cities.