[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.

[Immunological safety and sensitizing effect of an MB-7-based vaccine against hepatitis A]. / Immunologicheskaia bezopasnost' i sensibiliziruiushchee deistvie vaktsiny protiv gepatita A na osnove shtamma MB-7.

The influence of a vaccine based on the MB-7 strain of hepatitis A virus (VP-MB-7) designed at the "Vector" Center of Virology and Biotechnology was studied. VP-MB-7 was found to provoke no allergic response and to have an activating effect on the specific and non-specific responses of cell and humoral immunity similar to those evoked by hepatitis A vaccine "Hep-A-in Vac".

[Safety research of a vaccine preparation in hepatitis A derived from the MB-7 rapidly growing strain]. / Izuchenie bezvrednosti vaktsinnogo preparata protiv gepatita A iz bystrorastushchego shtamma MB-7.

A study was undertaken to prove that a vaccine drug based on the fast-growing MB-7 (MB-7 VD) of hepatitis A virus (HAV) is safe. It was established that MB-7 VD, when once injected to white outbred mice and when 4 times injected to Hartley guineas pigs, did not cause any hematological and biochemical changes in the peripheral blood or in the condition of the central nervous system of experimental animals, which shows that MB-7 VD is free of any toxic properties.

[Expression of hepatitis A virus recombinant proteins in Escherichia coli]. / Ekspressiia rekombinantnykh belkov virusa gepatita A v Escherichia coli.

On the basis of coding regions on the fragments of genes P1 and P2 of hepatitis A virus (HAV) recombinant proteins of this virus have been synthesized in the prokaryotic expressing system of E. coli, isolated and studied with the use of sera obtained from hepatitis A patients. The capacity of HAV recombinant proteins for binding with the sera of patients with hepatitis A in the acute stage has been shown with the use of immunoblotting and the indirect solid-phase enzyme immunoassay. The results obtained in this investigation are discussed in the light of the possible use of recombinant proteins for the detection of HAV markers.

[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.

[Comparative study of methods for determining antibodies to measles virus]. / Sravnitel'noe izuchenie metodov opredeleniia antitel k virusu kori.

The authors have developed enzyme immunoassay (EIA) for detecting antimeasles antibodies in the serum and compared it to routine methods. Preparation and purification of measles virus antigen used in EIA and optimal conditions of the reaction are described. Results of the routine methods and those of EIA correlated. EIA was used to determine titers of antimeasles antibodies in the sera of vaccinated children. 3-4 years after the vaccination the antibodies were undetectable in the sera of 23% of children.

[Comparative study of the immunogenicity of the inactivated hepatitis A vaccine Hep-A-in-vac from experimental and clinical data]. / Sravnitel'noe izuchenie immunogennosti inaktivirovannoi vaktsiny protiv gepatita A gep-A-in-vak po dannym éksperimental'nykh i klinicheskikh issledovanii.

Comparative analysis of the specific activities of various batches of Hep-A-in-Vac vaccine showed that the immunologic efficacy of the agent directly depended on the content of hepatitis A virus antigen in the vaccine dose. The results of studying the immunogenicity of the agent on volunteers are compatible with the results of experimental studies and indicate that the test of guinea pigs adequately assesses this characteristic. Assessment of the immunogenic properties of Hep-A-in-Vac prepared using improved technology indicates that Russian vaccine injected three times in a dose containing at least 40 U EIA ensures 87.5% seroconversion in adult seronegative volunteers with the mean geometrical titer of antibodies to hepatitis A virus equal to 683 mIU/ml.

[Optimization of preparation conditions of an inactivated hepatitis A vaccine and its characteristics]. / Optimizatsiia uslovii polucheniia inaktivirovannoi vaktsiny protiv gepatita A i ee kharakteristika.

Modernization of the protocol and optimization of the technology of preparation of inactivated hepatitis A vaccine helped prepare the experimental lots of inactivated vaccine meeting all the requirements to such preparations and the WHO recommendations.

[Evaluation of reactivity and immunogenicity of a cultured concentrated inactivated vaccine against hepatitis A "Hep-A-In-Vak"]. / Otsenka reaktogennosti i immunogennosti kul'tural'noi kontsentrirovannoi inaktivirovannoi vaktsiny protiv gepatita A "Gep-A-In-Vak".

Clinical trials of inactivated hepatitis A vaccine Hep-A-in-Vac demonstrated its specific safety and moderate reactogenicity, manifesting by short-term fibrillar twitching of musculus deltoideus at the site of injection. After a course of three immunizations 87.5% seronegative vaccines developed a high level of specific antibodies to hepatitis A virus with at least 100 reverse values of titers. In controls antibody titers remained seronegative in 90% cases. These data indicate evident immunologic activity of Hep-A-in-Vac vaccine.

[The isolation and study of the characteristics of a cytopathic strain of the hepatitis A virus]. / Vydelenie i izuchenie kharakteristik tsitopaticheskogo shtamma virusa gepatita A.

A fast-growing cytopathic isolate of human hepatitis A virus (strain MB-7) was derived from fecal samples of infected patients and adapted to growth in FRhK-4 cell culture. A positive serum standard against HAV and electron microscopy were used to demonstrate that MB-7 belonged to human hepatitis A virus. The strain MB-7 induced plaque formation in FRhK-4 under agar overlay after 10-12 days of incubation. The PCR products of gene VP1 were cloned in E. coli and its primary structure was determined. MB-7 was shown to have more homology with HAV strains isolated in the USA and China.