[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 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.

[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.

[A comparative evaluation of the immunogenicity and reactogenicity of recombinant vaccines against hepatitis B]. / Sravnitel'naia otsenka immunogennosti i reaktogennosti rekombinantnykh vaktsin protiv gepatita B.

Controlled epidemiological studies were carried out to evaluate two recombinant vaccines against hepatitis B of Cuban and Belgian production by the parameters of reactogenicity, safety and antigenic activity. Two groups of adult subjects (n = 73 each) and two groups of children (n = 30 each) were selected among those free from hepatitis B markers carrier state. The adults were given both preparations in a dose of 20 micrograms at intervals of 0-1-4 months, and the children received 10 micrograms at 0-1-2 months. The comparative studies showed both vaccines to be poorly reactogenic, safe and inducing anti-Hns in 80-100% of triply vaccinated subjects in titres within 100-500 IU. No statistically significant differences in the examined parameters were found in the two preparations tested.

[The vaccinal prevention of the HBsAg carrier state among newborn infants]. / Vaktsinoprofilaktika nositel'stva HBsAg sredi novorozhdennykh.

The paper presents the data on the time course of HBsAg carrier state in babies born to mothers with antigenemia indicating the dependence of the pattern of the antigen carrier state in babies upon the time of its primary detection. The stable (chronic) HBsAg carrier state in babies was shown to be formed after the first 3 months of life which attests to the necessity of using a vaccine against hepatitis B (HB) for prevention of HBsAg carrier state in newborns. The results of epidemiological survey in 185 babies developing HB with the analysis of all possible factors of their infection contraction are presented. The efficacy of the national plasma vaccine against hepatitis B is evaluated in observations of the newborn babies whose mothers were carriers of HBsAg. It was established that in vaccinated babies after 3 injections of the vaccine at 0, 1, and 6 months the rate of antigen detection was 3.3% and that of antibody 80% whereas in babies of the control group these values were 23.7% and 8.0%, respectively.

[Patterns in perinatal infection with the hepatitis B virus in areas contrasted by the level of HBsAg and HBeAg carriage]. / Zakonomernosti perinatal'nogo infitsirovaniia virusom gepatita B na territoriiakh, kontrastnykh po urovniu nositel'stva HBsAg i HBeAg.

In 1984-1988, the levels of HBsAg carrier state and the status of the "e"-system components in pregnant women in Moscow and in the Uzbek SSR, as well as the rate of infection with hepatitis B virus (HBV) in babies born to women carriers of HBsAg in regions with different levels of HBsAg and HBeAg carrier state were studied. The levels of HBsAg carrier state among pregnant women were different in Moscow and Uzbekistan (1.1% and 6.9%, respectively). It was noted that in female HBsAg carriers in these regions the rate of HBeAg detection differed greatly: 5.2% in Moscow and 13.9% in Uzbekistan. The frequency of perinatal infection with HBV in Moscow was 26.1%, in Uzbekistan 40.0%, the frequency of persistent carrier state of HBsAg in the infected babies of Uzbekistan was 16.0%. The possibility of formation of HBsAg persistence in babies born to women with HBsAg and anti-HBe in the blood was demonstrated. The problem of the use of specific prophylaxis measures to prevent perinatal transmission of HBV is discussed.

[A plasma subunit vaccine against hepatitis B studied in field trials]. / Izuchenie sub''edinichnoi plazmennoi vaktsiny protiv gepatitia B v polevykh ispytaniiakh.

The work presents materials on the study of subunit plasma vaccine against hepatitis B (HB), developed in the USSR, in a controlled epidemiological trial. The study showed low reactogenicity and complete safety of the preparation, the level of anti-HBsAg antibodies in persons, formerly found to have no such antibodies, being 88% after three injections of the vaccine. To determine the prophylactic effectiveness of the vaccine, the test and control groups, each consisting of 500 children, were formed from children aged 1-3 years, i.e. belonging to the age group most frequently affected by HB, by the method of random choice. During 18 months from the time of immunization no cases of HB were registered among the vaccinees, while in the control group 5 cases of HB were registered (8.9 per 1000). These results indicate that the plasma vaccine against HB, newly developed in the USSR, is faintly reactogenic, safe and shows sufficiently high antigenic activity and protective potency correlating with this activity.

[Perinatal infection with hepatitis B virus and the problem of its specific prevention]. / Perinatal'noe infitsirovanie detei virusom gepatita B i voprosy spetsificheskoi profilaktiki.

The incidence of HBs- and HBe-antigens detection in future mothers was studied in Moscow, Uzbekistan, and Moldavia, and the incidence of hepatitis B (HB) virus transmission from mothers with persisting HBs-antigenemia to their offspring. In reverse passive hemagglutination test, HBsAg was detected in 1.1% of pregnancies in Moscow, in 6.3% of pregnancies in Uzbekistan, and in 5.4% of pregnancies in Moldavia. In these regions, immunofluorescence revealed HBe-antigen in HBsAg carriers in 5.2, 13.9, and 16.3%, respectively. Perinatal infection with HB virus was found in 26.1% of births to HBsAg carriers in Moscow and in 40% in Uzbekistan and Moldavia; in the latter two regions 16.0% and 13.3% of these births were found to become chronic carriers of HBsAg. In the presence of persistence of HBeAg in HSsAg carriers, from 89 to 100% births to these mothers showed the development of durable HBs-antigenemia, while in the presence of anti-HBe such outcome was noted in only 3%. Specific anti-HBs-immunoglobulin administered to infants born to HBsAg carriers exerted a protective effect by reducing the HB virus infection rate in the first 6 months of life, but failed to prevent completely the development of HB virus infection. The necessity of a wide-scale vaccination against HB in order to prevent HB virus infection of neonates is emphasized.

[Characteristics of the formation of the HBsAg carrier state among pregnant women and newborn infants and their role in the spread of hepatitis B]. / Osobennosti formirovaniia nositel'stva HBsAg sredi beremennykh i novorozhdennykh i ikh rol' v rasprostranenii gepatitia B.

The authors analyze the incidence rate of HBsAg carriership among 8, 120 pregnant women and 261 newborn infants at different periods after birth. The levels of HBsAg carriership among pregnant women and the members of their families, as well as among the personnel of maternity clinics and blood donors, have been established. The rate and time of the detection of HBsAg in infants born to mothers found to be HBsAg carriers have been determined. Measures for the prophylaxis of hepatitis B are discussed with due regard to the specific epidemiological features of the spread of HBsAg carriership, established in this study, and to the presence of antibodies to HBsAg among the above-mentioned groups of the population.

[Evaluation of the effectiveness of a specific immunoglobulin against hepatitis A]. / Otsenka éffektivnosti spetsificheskogo immunoglobulina protiv gepatita A.

The present work deals with the controlled trial aimed at the study of the effectiveness of specific immunoglobulin against hepatitis A, developed in the USSR. This immunoglobulin is prepared from carefully selected blood sera from persons who have had hepatitis A. In accordance with the program approved by the USSR Ministry of Health, two trials were organized among the most susceptible groups of the population: organized groups of preschool children and young adults. During 6 months of the subsequent surveillance carried out in both age groups, the highest morbidity rate in hepatitis A was registered among the nonimmunized subjects. Morbidity rate among the subjects immunized with common commercial immunoglobulin was 3-7 times higher than among those immunized with the specific preparation, but a small size of the groups and a low morbidity level prevented the statistically significant confirmation of this higher effectiveness. Specific immunoglobulin produced a statistically significant (t = 2.72 and 2.4) decrease in morbidity rate among the immunized subjects in both age groups in comparison with morbidity rate among the nonimmunized ones.

[Effect of immunoglobulin prophylaxis on the incidence of the development of anicteric forms of hepatitis A]. / Izuchenie vliianiia immunoglobulinoprofilaktiki na chastotu formirovaniia bezzheltushnykh form gepatita A.

As the result of the clinico-biochemical examination of children in the foci of hepatitis A, carried out under the conditions of a strictly controlled epidemiological trial, the data on the frequency of the formation of the anicteric forms of hepatitis A in the course of the realization of different tactics of immunoglobulin prophylaxis have been established. The administration of immunoglobulin in a single injection has been shown to decrease the number of both manifest and anicteric forms of hepatitis A two times in comparison with the control. The administration of the preparation on contacts with hepatitis A patients in areas with a high morbidity level has been found to produce no decrease in the frequency of the manifest and anicteric forms of hepatitis A, this frequency remaining on the level registered in the control groups.

[Comparative evaluation of the effectiveness of 2 methods of immunoglobulin prophylaxis of hepatitis A in areas with high morbidity in this infection]. / Sravnitel'naia otsenka éffektivnosti dvukh metodov immunoglobulino-profilaktiki gepatita A na territoriiakh s vysokim urovnem zabolevaemosti étoi infektsiei.

The article presents the results of a strictly controlled epidemiological experiment on the comparative evaluation of the effectiveness of two methols used for the immunoglobulin prophylaxis of hepatitis A; the simultaneous injection of immunoglobulin to all persons at risk at the beginning of the seasonal rise of morbidity and the injection of the preparation to all persons having contacts with hepatitis A patients in the foci of this infection as such foci appear. These results indicate that in the presence of a sufficiently high morbidity rate the injection of immunoglobulin at the beginning of the seasonal rise of morbidity proved to be most effective. Such use of immunoglobulin made it possible to decrease hepatitis A morbidity 2.1 times in comparison with the control groups and 1.5 times in comparison with the groups receiving the preparation in the foci of infection as such foci appeared.

[Effect of the content of hepatitis A antibodies in immunoglobulin preparations on the effectiveness of the immunoglobulin prophylaxis of hepatitis A]. / Vliianie soderzhaniia antitel k virusu gepatita A v preparatakh immunoglobulinov na éffektivnost' immunoglobulinoprofilaktiki gepatita.

The results of a strictly controlled experiment showed that prevention of hepatitis A by the injection of immunoglobulin with hepatitis A virus (HAV) antibody titer 1:10000 was 3 times as effective as that achieved with immunoglobulin containing HAV antibodies in titer 1:2500. It is recommended to determine the level of specific HAV antibodies in immunoglobulins and to use immunoglobulins with a high level of HAV antibodies for prevention of hepatitis A.

[Effect of multiple gamma globulin administration on the effectiveness of seroprophylaxis in hepatitis A]. / Vliianie mnogokratnogo vvedeniia gamma-globulina na éffektivnost' seroprofilaktiki gepatita A.

The data provided by immunological and epidemiological studies carried out to determine the influence of the multiple injections of 10% commercial gamma globulin on the level of antigamma globulin formation and, in this connection, on the effectiveness of the prophylaxis of hepatitis A are discussed. A sharp increase in the titers of antigamma globulin in persons receiving multiple gamma globulin injections is shown. The increased amount of antibodies to gamma globulin, appearing as the result of the multiple use of this preparation, decreases the effectiveness of the seroprophylaxis of hepatitis A.