[Diagnostic value of enzyme immunoassay test for the detection of specific IgM antibodies to measles virus].

The diagnostic value of enzyme immunoassay systems manufactured by different companies was comparatively studied to detect specific IgM antibodies to measles virus. The assay systems were shown to have a high sensitivity. The specificity was higher in the assay systems designed on the capture principle, a type of solid-phase enzyme immunoassay.

[The comparative study of the safety of a vaccinal process in both oral and epicutaneous immunization against smallpox]. / Sravnitel'noe izuchenie bezopasnosti vaktsinal'nogo protsessa pri oral'noi i nakozhnoi protivoospennoi immunizatsii.

Results of comparative studies of tableted and epicutaneous live smallpox vaccines are presented. In experiments on rabbits by using histological, immunofluorescent, immunological and virological methods, higher safety and efficiency of the tableted vaccine than that of traditional smallpox epicutaneous vaccine were determined. The natural and physiological character of oral immunization was shown. The oral immunization was concluded to be a safe method of inoculation now and perspective for the use of recombinant vaccines based on vaccine virus in the absence of population immunity against smallpox.

[Anti-HIV vaccines: state of the art and prospects]. / Sostoianie i perspektivy razrabotki vaktsin protiv VICh-infektsii.

The results of clinical trials of three types of candidate anti-AIDS vaccines are presented. Immunogenicity of different vaccine types and modern requirements to vaccines are analyzed. The advantages and disadvantages of protein, vector, and DNA vaccines and various protocols of vaccination are discussed and the advantages of the priming-booster immunization protocol are emphasized. Information about phase III clinical trials are presented. Tentative terms of introduction of vaccines into practice are presented.

[Preparation and selection of monoclonal antibodies for detecting hepatitis B surface antigen in blood sera]. / Poluchenie i otbor monoklonal'nykh antitel dlia vyiavleniia poverkhnostnogo antigena virusa gepatita B v syvorotkakh krovi.

HV monoclonal antibodies (MAb) were produced in order to improve the quality of HBsAg detection and their specific characteristics were compared with those of other MAbs. MAbs were characterized by asymmetric interactions with the antigen when used as first or second antibodies. The reactivity of a panel of HV and X MAb to ad and ay subtypes was studied by enzyme immunoassay. Mutual blocking (epitope mapping) of MAb helped select antibody couples for the creation of highly effective test system for the diagnosis of the major HBsAg subtypes. The sensitivity and specificity of MAbs were evaluated on reference and control panels of HBsAg sera and on serum specimens from a random sampling of 300 blood donors. The sensitivity of the most specific MAb pairs was 0.1 ng/ml for HBsAg subtype ay and 0.25 ng/ml for subtype ad. The specificity of attested MAb was 98.5% in incubation with stirring and 97% in static incubation. The optimal combinations of attested MAbs were used in the manufacture of Recomnathep B test system in the sandwich format.

[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.

[Comparative evaluation of neurovirulence of domestic and foreign live mumps vaccine]. / Sravnitel'naia otsenka neirovirulentnosti otechestvennoi i zarubezhnykh zhivykh parotitnykh vaktsin.

Morphological and immunofluorescent study of changes in the central nervous system of monkeys with mumps was carried out in order to determine the criteria of neurovirulence of different mumps virus strains. Quantitative evaluation showed a lower residual neurovirulence of L-3 strain vs. Jeryl Lynn and Urabe Am9 strains. Use of new methodological approaches to evaluation of mumps vaccine strain neurovirulence will improve the safety control of live mumps vaccines.

[Reactions to and immunogenic properties of the combined vaccine Bubo-M for immunization of children against diphtheria, tetanus and viral hepatitis B]. / Reaktogennost' i immunogennost' kombinirovannoi vaktsiny Bubo-M pri immunizatsii detei protiv difterii, stolbniaka i virusnogo gepatita B.

Bubo-M, the first Russian combined vaccine, was found to have low reactogenicity. The difference between the number of postvaccinal reactions in the group of children immunized with Bubo-M (25.9%) and those in the group of children who had been simultaneously injected into different sites of the body with ADS-M toxoid (adsorbed DT toxoid with reduced antigen content) and hepatitis B vaccine (26.7%) was not statistically significant. Following immunization a considerable increase in the level of diphtheria and tetanus antibodies (p < 0.005) was observed in all children (100%), the level of HBs antibodies in the group of children immunized with Bubo-M (the geometric mean titer: 13,721 IU/l) essentially exceeding that observed in the control group injected with ADS-M toxoid and hepatitis B vaccine (the geometric mean of the titer: 2,441 IU/l). Bubo-M was duly registered and allowed for industrial production and medical use.

[Evaluation of reactogenicity and immunogenicity of Bubo-M, the Russian combined vaccine for immunization of adults against diphtheria, tetanus and viral hepatitis B]. / Otsenka reaktogennosti i immunogennosti otechestvennoi kombinirovannoi vaktsiny Bubo-M pri immunizatsii vzroslykh protiv difterii, stolbniaka i virusnogo gepatita B.

Bubo-M, the first Russian associated vaccine, was found to have low reactogenicity and high immunogenic potency. The frequency of postvaccinal reactions in the group of persons immunized with Bubo-M (20%) appeared to be considerably lower than among persons who received the combined injection of adsorbed DT toxoid with reduced antigen content and vaccine against hepatitis B (47.7%). Following the course of vaccination the level of anti-HBs considerably exceeded the protective level. Immune response to the diphtheria and tetanus components of Bubo-M exceeded that observed after immunization with absorbed DT toxoid with reduced antigen content (p < 0.05).

[Construction of reference panel of immune serum against hepatitis C virus with standard level of IgG antibodies]. / Konstruirovanie referens-panelei syvorotok k virusu gepatita C s normirovannym urovnem IgG-antitel.

A panel of anti-HCV sera (lot 03HC) was prepared from human sera obtained at blood transfusion centers and infectious hospitals. Donor sera and high-titer sera from patients infected with HCV were used. For positive samples, specific sera reactive with the core and/or NS proteins of HCV 1b and 2 were selected. Positive sera were standardized by the concentrations of IgG with a pool of negative sera containing no HBsAg and antibodies to HIV, HCV, and syphilis. The sera for the panel were selected and titered in screening and specific tests. The anti-HCV panel includes negative and positive sera with low and high titers. The panel sera are stabilized and can be stored for a short time at room temperature. The anti-HCV panel of sera, lot 02HC, was certified at L. A. Tarasevich Institute for Standardization and Control as anti-HCV reference panel intended for sensitivity, specificity, and stability control of diagnostic systems for detection of antibodies to HCV in Russia.

[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.

[Experimental study of residual virulence of viral vaccine strains]. / Eksperimental'noe izuchenie ostatochnoi virulentnosti shtammov virusa vaktsiny.

Residual virulence of three vaccinia strains: Neurovaccine, L-IVP, and its recombinant Revacs-B expressing HBs and preS2 antigens of hepatitis B virus is compared. Insertion of HBs and preS2 antigens of hepatitis B virus in the genome of vaccinia virus strain L-IVP decreases its residual virulence and leads to a benign course of vaccinal reaction involving no deaths of rabbits, cotton rats, or guinea pigs. We may expect that recombinant vaccine Revacs B based on L-IVP strain will cause no postvaccinal complications under conditions of an appreciable decrease in population immunity to vaccinia virus.

[Certification of a kit for immunologic tests]. / O sertifikatsii nabora dlia immunologicheskikh ispytanii.

A diagnostic kit for the determination of IgG antibodies to diphtheria toxin ("Abion", Germany) the use of analytical columns "Abicap" was studied in the specialized laboratory of the Tarasevich State Control Institute with a view to determine the possibility of its official registration in the Russian Federation. The kit was evaluated by the following criteria: the correspondence of the specified properties of the preparation to those actually observed; meeting the norms stated in the documents supplied with the kit and WHO requirements; the presence of advantages in comparison with the enzyme immunoassay. In the course of the trial positive results were obtained on all these points.

[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.