[STUDY OF SAFETY OF PAROTITIS VACCINE].

AIM: Monitoring of post-vaccinal complications in children immunized with a parotitis vaccine. MATERIALS AND METHODS: Observation of 198 945 children, immunized with 16 lots of parotitis vaccine with Leningrad-3 strain (L-3), was carried out for 3 years. Paired samples of sera and saliva were obtained from children, in whom adverse events were registered for 42 days after vaccination. Titers of specific IgM and IgG were determined in blood sera. Analysis of nucleotide sequences of genes F, SH and NH of RNA of parotitis virus was carried out from samples of blood and saliva. RESULTS: Intensive parameter of vaccine-associated aseptic meningitis under the conditions of the experiments was 0 for 100 000 immunized. Frequency of occurrence of post-vaccinal parotitis was 0.06% from the number of vaccinated--18 cases of vaccine-associated parotitis were registered and laboratory confirmed. A significant difference in specific activity was detected for 3 lots of the vaccine, that were associated with cases of development of parotitis, relative to that of 13 lots of vaccine, development of parotitis was not registered after administration of those. CONCLUSION: The study carried out confirmed low neurovirulence of the parotitis vaccine with the L-3 strain of parotitis virus, as well as a low degree of its reactogenicity. A relatively high immunization dose of the used vaccine could be one of the reasons of development of post-vaccinal complications in part of the immunized children.

[The immunological effectiveness and reactogenicity of the vaccine "HEP-A+B-in-VAC" against hepatitis A and B].

The paper presents the results of field clinical tests of the new Russian vaccine "HEP-A+B-in-VAC" against hepatitis A and B. The vaccine has been found to be safe and to have a weak reactogenicity. After completion of a course of vaccination, seroconversion occurred in 100% of the vaccinated, the high titers of anti-HAV and HBs being found in 90.9 and 72.7% of the volunteers, respectively. A comparative analysis demonstrated that the reactogenicity of the new vaccine was less and its immunogenicity was higher than those in monovaccines against hepatitis A and B when they were co-administered.

[Evaluation of the diagnostic efficacy of a test system for detecting hepatitis virus C RNA by polymerase chain reaction "AmpliSens(TM) HCV-240/BKO-440)"]. / Otsenka diagnosticheskoi éffektivnosti tests-sistemy dlia vyiavleniia RNK virusa gepatita C metodom polimeraznoi tsepnoi reaktsii "AmpliSens(TM) HCV-240/VKO-440".

The test system developed at the Central Research Institute of Epidemiology, Ministry of Health of the Russian Federation for identification of hepatitis C virus RNA was studied. The sensitivity of the test system which the rate of similar results was 100% with its 5-fold reproduction was evaluated. That was 5 x 103 genomic equivalents (or international units) per ml of a sample. A scheme for evaluation of the reproductibility of test systems based on the polymerase chain reaction (PCR) by using model samples is proposed. Whether it can be used for intra- and extra-laboratory assessment of the quality of PCR analyses is discussed.

[Serodiagnosis of chlamydiosis: "Chlamy-IgG-DS-Tr"-- the first domestic immunoenzyme recombinant test-system for determination of anti-Chlamydia trachomatis class G antibodies]. / Serodiagnostika khlamidiozov. "Khlami-IgG-DS-Tr"--pervaia otechestvennaia immunofermentnaia rekombinantnaia test-sistema dlia vyiavleniia antitel klassa G k Chlamydia trachomatis.

The first Native test-system for determination of class G antibodies to Chlamydia trachomatis with chlamydia recombinant antigen was elaborated Test-system efficacy was demonstrated in clinical trials. The sensibility, specific activity and suitability of the "Chlamy-IgG-DS-Tr" were the same as for import analogous.

[The evaluation of the reactogenicity, harmlessness and prophylactic efficacy of Grippol trivalent polymer-subunit influenza vaccine administered to schoolchildren]. / Otsenka reaktogennosti, bezvrednosti i profilakticheskoi éffektivnosti grippoznoi trivalentnoi polimer-sub''edinichnoi vaktsiny "Grippol" pri vvedenii detiam shkol'nogo vozrasta.

Vaccine "Grippol"--has been developed at the State Research Center--Institute of Immunology. The preparation belongs to new generation vaccines and is a trivalent polymer-subunit vaccine containing the sterile conjugate of influenza virus surface proteins, types A and B, bound with copolymer polyoxidonium. The administration of "Grippol" to children of school age (6-18 years) demonstrated low reactogenicity of the vaccine, its safety and sufficient prophylactic effectiveness. During observations on total morbidity (with the exception of influenza and acute respiratory diseases) no side effects produced by "Grippol" were registered. At the same time the fact that the morbidity rate of upper respiratory tract disease in the group of children immunized with the vaccine decreased in comparison with the control group (by 2.4 times) cannot be disregarded.

[Characteristics of "Avaxim" hepatitis A vaccine produced by the firm "Pasteur Merrier" (results of field clinical trials)]. / Kharakteristika vaktsiny protiv gepatita A "Avaxim" proizvodstva firmy "Paster Mer'e" (rezul'taty polevykh klinicheskikh ispytanii).

Controlled field clinical trials of Avaxim vaccine from hepatitis A (Pasteur-Merrier-Connot) were carried out in adults and children aged 3-14 years to evaluate its reactogenicity and antigenic properties. The vaccine was weakly reactogenic both in adults and children. A single injection of the vaccine resulted after 1 month in the production of anti-HAV antibodies in 77.4% initially seronegative adults and 94.5% children. In adults the mean geometrical titer of antibodies was 95 mIU/ml and in children 165 mIU/ml, which was 5-8 times higher than the protective titer. These data recommend Avaxim vaccine for practical public health.

[Comparative study of the reactivity, safety and immunogenicity of "Havrix" inactivated hepatitis A vaccine]. / Sravnitel;noe izuchenie reaktogennosti, bezopasnosti i immunoennosti inaktivirovannykh vaktsin protiv gepatita A "Havrix".

This paper sums up the results of controlled field clinical trials of adult and childhood variants of Harvix, inactivated vaccine from hepatitis A. The vaccine is weakly reactogenic and safe. After a single injection of Harvix-1440 vaccine to adults the percentage of seroconversions in previously seronegative individuals was 80.6%, with the mean geometrical antibody titer 119 mIU/ml. In children aged 3-10 years the percentage of seroconversions after a single injection of Harvix-720 vaccine was 100%, the mean geometrical of antibody titer being 427 mIU/ml. Results of laboratory control and field clinical trials recommend both variants of Harvix vaccine for prevention of hepatitis A in the Russian Federation.

[Characteristics of reactogenic and immunogenic properties of the children's variant of the domestic vaccine, "Gep-A-in-Vak", against hepatitis A]. / Kharakteristika reaktogennykh i immunogennykh svoistv detskogo varianta otechestvenoi vaktsiny protiv gepatita A "Gep-A-in-Vak".

Russian cultural concentrated inactivated vaccine protecting from hepatitis A--Hep-A-in-vac was used for immunization of children. The vaccine is slightly reactogenic and completely safe in children aged 3-17 years vaccinated twice in a dose of 0.25 ml. Double immunization of seronegative children with a 1-month interval led to conversion in 89.7% children. In 64.1% children titers of antibodies to hepatitis A virus reached 20 mIU/ml and higher, which indicates rather high antigenic activity of the vaccine.

[The results of the registration clinical trials of the Act-Hib vaccine manufactured by the firm of Pasteur Mérieux Connaught, France]. / Rezul'taty registratsionnykh klinicheskikh ispytanii vaktsiny "Akt-Khib" proizvodstva firmy "Paster Mer'e Konnot", Frantsiia.

The results of the field trials of the vaccine "Act-Hib" against Haemophilus influenzae of type b, presented for registration by Pasteur Mérieux Connaught (France), are summarized. The vaccine was found to have low reactogenicity and high immunological effectiveness. A single injection of the vaccine induced the formation of the protective level of anti-PRP antibodies in 94% of the immunized children aged 1-4 years. After immunization the mean geometric titers of specific antibodies increased sixfold in comparison with the initial level and were equal to 3.4 mu/ml. On the basis of the data of laboratory control and field clinical trials the vaccine "Act-Hib" was registered in the Russian Federation and permission and its practical use in the public health service of the country was permitted.

[The evaluation of the reactogenicity and immunogenic activity of a new concentrated inactivated leptospirosis vaccine]. / Otsenka reaktogennosti i immunogennoi aktivnosti novoi kontsentrirovannoi inaktivirovannoi leptospiroznoi vaktsiny.

In the controlled field trial the reactogenicity, safety and antigenic activity of a new concentrated inactivated leptospirosis vaccine after its administration in one and two injections of 0.5 ml were studied in comparison with those of the existing commercial vaccine, introduced in two injections in doses of 2.0 and 2.5 ml. The new experimental vaccine exhibited low reactogenicity and was found to be safe and highly immunogenic when introduced in a single injection of 0.5 ml. As shown in this trial, the immunogenic characteristics of immunization made in a single injection were not inferior than those obtained as the result of immunization made in two injections, yielding high percentage of seroconversions (89.8% to 98.3%) with respect to 4 Leptospira serogroups and leading to the production of the protective titers of corresponding antibodies. The existing commercial vaccine was inferior to the experimental one in antigenic activity (the frequency of seroconversions, antibody titers). The results of the trial make it possible to recommend the experimental concentrated leptospirosis vaccine for use in medical practice in a dose of 0.5 ml introduced in a single injection.

[A cultured concentrated inactivated vaccine against tick-borne encephalitis studied during the immunization of children and adolescents]. / Izuchenie kul'tural'noi kontsentrirovannoi inaktivirovannoi vaktsiny protiv kleshchevogo éntsefalita pri immunizatsii detei i podrostkov.

The word deals with the results obtained in the study of the reactogenicity and immunological activity of concentrated and inactivated tissue-culture tick-borne encephalitis vaccine, manufactured by the Chumakov Institute of Poliomyelitis and Viral Encephalitides, in the immunization of children and adolescents. The vaccine proved to be moderately reactogenic and exhibited pronounced immunological activity. In 91.5% of the immunized children the fourfold increase of the antibody level was observed. On the basis of the data obtained in this study the tick-borne encephalitis vaccine was recommended for use in medical practice for the prophylaxis of tick-borne encephalitis among children and adolescents.

[Evaluation of the effectiveness of influenza trivalent polymer subunit vaccine "Grippol"]. / Otsenka éffektivnosti grippoznoi trivalentnoi polimer-sub"edinichnoi vaktsiny "grippol".

Influenza polymer-subunit vaccine "Grippol", made up of the sterile conjugate of surface proteins of influenza viruses, groups A and B, with polyoxidonium (copolymer), was obtained at the State Scientific Centre of Research Institute of Immunology. As the result of our investigations, the coefficient of prophylactic effectiveness of vaccine "Grippol" was found to be 71%; in the presence of the 50% immune stratum in the group the coefficient of antiepidemic protection was found to be 66.4%. At the same time, cases of influenza and acute respiratory diseases were shown to take a milder form in persons immunized with vaccine "Grippol" than in the group of nonimmunized subjects. The results of this investigation did not show any side effects caused by the vaccine.

[Hep-A-in-Vac, a Russian cultured concentrated inactivated vaccine against hepatitis A]. / Izuchenie otechestvennoi kul'tural'noi kontsentrirovannoi inaktivirovannoi vaktsiny protiv gepatita A "Gep-A-in-Vak".

The results of the study of the reactogenicity, safety and immunological activity of Russian cultural vaccine against hepatitis A are presented. The vaccine was found to have specific safety, moderate reactogenicity and pronounced immunological activity. In addition, the study of the prophylactic efficiency of the vaccine in the pre-epidemic period of the outbreak of hepatitis A morbidity in a group exceeding 14,000 adults was carried out. The study revealed high prophylactic efficiency of the vaccine (its efficiency rate was equal to 97.7%). On the basis of materials thus obtained vaccine "Hep-A-in-Vac" was recommended for use in medical practice for the prophylaxis of hepatitis A among adults.

[Results of controlled tests of an experimental recombinant live vaccine against hepatitis B]. / Rezul'taty kontroliruemykh ispytanii éksperimental'noi rekombinantnoi zhivoi vaktsiny protiv gepatita B.

Experimental recombinant vaccine against hepatitis B Revacc B based on vaccinia virus has been tried. The preparation was weakly reactogenic but did not induce the production of anti-HBasAg antibodies. On the other hand, recombinant vaccine against hepatitis B Engerix B, used in a blind experiment as the agent of comparison, induced the production of anti-HBs in 91% of vaccinees.

[The efficacy of recombinant vaccines against hepatitis B and the results of their use in a schedule for pediatric prophylactic inoculations]. / Effektivnost' rekombinantnykh vaktsin protiv gepatita B i rezul'taty ikh primeneniia v kalendare detskikh profilakticheskikh privivok.

The results of field clinical trials of Russian and American yeast vaccines against hepatitis B are presented. The study revealed that both vaccines were faintly reactogenic, safe and exhibited high immunological activity. After the full course of immunization following the schedule 0-1-2 months 92.5% and 97.5% of patients receiving, respectively. Russian vaccine "Combiotech" and American vaccine "H-B-Vax II" were found to have specific antibodies. The maximum effect was registered when the vaccines were introduced according to the schedule 0-1-6 months. Seroconversions were observed in 97.5% and 100% of the vaccinees receiving the Russian and American vaccines respectively, in the latter case the highest antibody level being observed. The use of the vaccines within the prophylactic immunization schedule showed that antibodies to hepatitis B appeared in immunized children in 93-100% of cases. Seroconversion indices and the levels of antibodies to diphtheria, tetanus, poliomyelitis and measles were statistically significant and were the same in children receiving only the vaccines according to the immunization schedule and in children immunized, in addition to these vaccines, against hepatitis B.

[Comparative study of inactivated cultured vaccines against tick-borne encephalitis manufactured in Russia and in Austria by the "Immuno" firm]. / Sravnitel'noe izuchenie inaktivirovannykh kul'tural'nykh vaktsin protiv kleshchevogo 7entsefalita otechestvennogo proizvodstva i proizvodstva firmy "Immuno" (Avstriia).

Inactivated culture vaccine against tick-borne encephalitis (TBE) FSME-Immun-Inject produced in Austria ("Immuno") was compared to vaccine produced in the Institute of Poliomyelitis and viral encephalitis by immunological activity, safety, reactogenicity. In mice, no significant differences in protective activity of the vaccines were found when test-strains were diverse strains of TBE virus. Seroconversion in the sera from the vaccinated two times was not significantly different by the level of antibodies determined for both eastern and western serotypes of TBE virus.

[Russian recombinant vaccine against hepatitis B (results of controlled trials)]. / Otechestvennaia rekombinantnaia vaktsina protiv gepatita B (rezul'taty kontroliruemykh ispytanii).

Two yeast recombinant vaccines were compared: the Russian hepatitis B Combiotech vaccine in a dose of 20 mg and the Recombivax-HB vaccine in a dose of 10 mg manufactured in the USA (Merk, Sharp and Dohme Ltd.). Both agents were found safe and low reactogenic. After a course of 3 vaccinations with the Russian vaccine 92.5 to 97.5% subjects vaccinated after the 0-1-2 months and 0-1-6 months protocols had high levels of specific antibodies. In the group vaccinated with the American vaccine, antibodies to HBsAg were found in the sera of 95 to 100% subjects. These results demonstrate high immunological activity of both Russian and American vaccines.