[Testing for the safety, reactogenicity and antigenic properties of a live thermostable mumps vaccine made from the Leningrad-3 strain]. / Proverka bezopasnosti, reaktogennosti i antigennykh svoistv zhivoi parotitnoi termostabil'noi vaktsiny iz shtamma Leningrad-3.

A live mumps vaccine (LMV) from strain Leningrad-3 with a new stabilizer LS-18 was tested for reactogenicity and antigenic potency. Examinations of vaccinated children for vaccination reactions showed its complete areactogenicity and safety. LMV induced synthesis of virus-neutralizing antibodies in 78-82% of the vaccinees. Determinations of the dynamics, intensity and duration of circulation of specific antihemagglutinating, antineuraminidase and virus-neutralizing antibodies demonstrated marked antigenic potency of the LMV and established production of earliest specific antineuraminidase antibodies in 75% of the vaccinees. EIA was found to be the most sensitive test.

[The immune status of children in foci of measles infection studied by an immunoenzyme method]. / Izuchenie immunnogo statusa detei v ochagakh korevoi infektsii metodom IFA.

Children immunized with live measles vaccine in the foci of measles infection varying in intensity (1-9 cases per focus) have been subjected by two methods: the hemagglutination inhibition (HAI) test and the enzyme immunoassay (EIA). As shown in this study, in most cases (98% of all blood serum samples) the correlation between the results of the HAI test and EIA is not high (r = 0.5), which is linked with the detection of a wider spectrum of antibodies in EIA. The percentage of seronegative children detected by these two methods was practically the same (4.05 and 4.4, respectively). The analysis of the results obtained in this study indicates that EIA is a more informative and sensitive method, which confirms the effectiveness of its use for the determination of the level of collective immunity.

[Verification of the safety, inoculability, reactogenicity and antigenic properties of a live recombinant smallpox-hepatitis B vaccine in an experiment in volunteers]. / Proverka bezopasnosti, privivaemosti, reaktogennosti i antigennykh svoistv zhivoi rekombinantnoi ospenno-gepatitnoi B-vaktsiny v opyte ne dobrovol'tsakh.

Trials of the first Soviet live recombinant smallpox-hepatitis B vaccine (SHBV) in volunteers (20 men aged 18-20 years) showed its safety, good "take"-rate, and lower reactogenicity as compared with the standard smallpox vaccine (LIVP strain). Smallpox virus-neutralizing antibodies in response to SHBV were produced as well as in response to the smallpox vaccine. Revaccination of human subjects with smallpox vaccine and SHBV 45 days after the previous vaccination resulted in antibody booster to vaccinia virus. After two inoculations of SHBV at an interval of 45 days no anti-HBsAg antibodies were found for 3 months after the last vaccination. However, even a single vaccination with SHBV induced priming to HBsAg. This could be demonstrated after inoculation of the subjects vaccinated with SHBV with one dose of plasma hepatitis vaccine. In the subjects vaccinated with SHBV antibody in response to the plasma vaccine formed more frequently and in higher titres than in those prevaccinated with smallpox vaccine or placebo.

[Attenuated recombinant influenza type B virus obtained during crossing of virus B/Ann Arbor/2/86 with the cold-adapted strain B/Leningrad/14/17/55]. / Attenuirovannyi rekombinant virusa grippa tipa B, poluchennyi pri skreshchivanii virusa B/énn arbor/2/86 s kholodoadaptirovannym shtammom B/Leningrad/14/17/55.

Crossing the cold-adapted B/Leningrad/14/17/55 strain with the temperature-sensitive virulent B/Ann Arbor/2/86 strain yielded a recombinant B/14/5/1 which, by the antigenic specificity of hemagglutinin and neuraminidase, corresponded to the B/Ann Arbor/2/86 strain but, like the attenuated donor, had the cold-adapter characteristics. The B/14/5/1 recombinant inherited the genes coding for proteins PB2, PB1, PA, NP, and M from the attenuated master strain and the genes coding for hemagglutinin, neuraminidase, and proteins NS from the virulent master strain. This strain was nonreactive for adults and for children with the initial anti-hemagglutinin antibody titre less than or equal to 1:20 (the reactogenic index being 1 and 0.9% respectively) and was moderately antigenic inducing a 4-fold or more rise of anti-hemagglutinins in the blood of 48.8% of seronegative adults and in 46.6% of seronegative children of 3 to 15 years of age. The highest indices of seroconversions (60%) were recorded in a group of preschool children.

[Effectiveness of a combined live mumps-measles vaccine]. / Issledovanie éffektivnosti zhivoi assotsiirovannoi parotitno-korevoi vaktsiny.

The reactogenic and areactogenic properties of a live combined mumps-measles vaccine (MMV) prepared in primary cultures of Japanese quail embryo cells from attenuated strains of mumps (L-3) and measles (L-16) viruses were under study. The observations involved 648 infants varying in ages from 1 to 3 years, seronegative to measles and mumps viruses, without the history of the disease and vaccinations against these infections or contraindications to vaccinations. The infants were vaccinated with 5 batches of MMV with different portions of the mumps and measles components. The vaccinees and controls (placebo injections) were observed for 30 days postvaccination. The live MMV was shown to be a safe, well tolerated preparation with low reactogenicity and a high antigenic activity.

[Genomic and antigenic analysis of strains of influenza A virus (H1N1) isolated in 1982-1983: approaches to the choice of the optimal vaccine strain]. / Genomnyi i antigennyi analiz shtammov virusa grippa A (H1N1) 1982-1983 gg. vydeleniia: podkhody k vyboru optimal'nogo vaktsinnogo shtamma.

Features of the genome and antigenic specificity of hemagglutinin of some influenza A (H1N1) virus strains circulating in the epidemic period of 1982-1983 were studied comparatively. Analysis of the genome of the isolates under study in comparison with that of the reference A/England/333/80 strain and with each other has established changes not only in the genes coding for hemagglutinin and neuraminidase but also most of the genes coding for unglycolysed proteins. The antigenic specificity of hemagglutinin of the isolates under study examined with rat antisera and monoclonal antibodies was found to be quite dissimilar. Hemagglutinin of the A/Dunedin/27/83 strain induced antibodies capable of reacting predominantly with the homologous strain whereas antibodies to hemagglutinin of the A/Leningrad/16/16/82 and A/Chile/1/83 strains had a wide spectrum of antigenic specificity and neutralized well the hemagglutinin of different variants of influenza virus of H1N1 serotype circulating at that time. Among the 1982-1983 isolates studied, the A/Leningrad/16/16/82 strain was selected which, by its hemagglutinin properties, is optimal for preparation of inactivated vaccine, as was confirmed by the study of an experimental batch of such vaccine in volunteers.

[Clinico-laboratory and seroepidemiological examinations of children immunized with live measles vaccine prepared from genetically homogeneous strain Moscow-5]. / Kliniko-laboratornye i seroepidemiologicheskie issledovaniia privitykh zhivoi korevoi vaktsinoi iz geneticheski odnorodnogo shtamma Moskva-5.

The results of the clinico-laboratory and epidemiological study of a newly developed live measles vaccine obtained from strain Moscow-5, genetically homogeneous and cloned from strain JI-16, are presented. The data indicate that the vaccine obtained from strain Moscow-5 is safe and possesses low reactogenicity and high immunological potency, thus meeting all requirements for vaccinal preparations.

[Results of human immunization with a new rabies vaccine containing no neuroallergenic brain tissue factor]. / Rezul'taty immunizatsii liudei novoi antirabicheskoi vaktsinoi, ne soderzhaschei neiroallergennogo faktora mozgovoi tkani.

Immunization with a vaccine prepared from sheep-brain-grown fixed rabies virus inactivated with beta-propiolactone was given to 146 subjects. The vaccine was by 80-90% purified from waste brain tissue substances (protein content less than 2 mg/ml) and showed no neuroallergenicity in guinea pig tests. Simultaneously 86 subjects were vaccinated with commercial Fermi vaccine. Immunization was performed according to the schedules accepted in the USSR. The new vaccine produced much fewer local reactions than Fermi vaccine (in 39.6% and 60.9% vaccinees, respectively) and 5 times as few systemic reactions (in 6.03% and 31.3% vaccinees, respectively). The antigenic potency of the new vaccine was as good as that of Fermi vaccine.

Characteristics of cell-mediated immunity after oral administration of a live influenza vaccine.

Development of immunological status of children after oral administration of a live influenza vaccine was followed using different tests of the cellular (blast transformation assay, identification of T, B and nil lymphocytes) and humoral (haemagglutination inhibition test, neuraminidase-inhibition test, neutralization test) immune response. Direct correlation was observed between the increase of neutralizing antibody and the lymphocyte stimulation indices in blast transformation assay (BTA). In vaccinated children the reactivity of lymphocytes was reduced and the amount of T lymphocytes decreased. The influenza vaccine has been shown to possess weak sensitizing properties.

[Characteristics of the immunological response in children to the administration of a live tissue-culture influenza vaccine]. / Osobennosti immunologicheskogo otveta detei na vvedenie zhivoi tkanevoi grippoznoi vaktsiny.

Various immunological tests were used for comprehensive study of vaccination immunity at the cellular level in children inoculated with different strains of influenza A virus. The characteristics of cell-mediated immunity in children vaccinated with a live tissue culture oral influenza vaccine were first obtained. There was a direct relationship between a rise in virus-neutralizing antibody levels and values of blast-transformation reaction. The live tissue culture influenza vaccine was shown to produce in children a short-time decrease in reactivity of lymphocytes, most significant changes occurring in the T-subpopulation of lymphocytes.

[Moscow Research Institute of Viral Preparations tissue-culture smallpox vaccine in a coded control experiments of adult revaccination by scarification]. / Izuchenie tkanevoi ospennoi vaktsiny MNIIVP v shifrovannom kontroliruemom opyte pri revaktsinatsii vzroslykh metodom skarifikatsii.

Comparative studies of tissue culture and dermal smallpox vaccines were carried out in a strictly controlled coded trial by revaccination of adults by scarification. Two lots of tissue culture and one lot of dermal vaccines with a similar infectious titer (8.0 lg PFU/ml) were used. All the lots tested "took" in 100%. In the group revaccinated with tissue culture vaccine seroconversion was observed in 94.2 +/- 2.8%--95.0 +/- 2.8%, with a 4.6 +/- 5.3-fold rise in geometric mean antibody titer; the dermal smallpox vaccine produced seroconversion in 85.7 +/- 4.4% with 4.3-fold rise in geometric mean antibody titer. Febrile reactions in revaccines with the tissue culture vaccine were observed in 23.1%--26.1% which did not exceed this parameter in the group revaccinated with the dermal vaccine (25.2%); in all the groups febrile ractions were of mild degree (37.1 degrees--38 degrees C). Local reactions of the type of confluent erythema were observed 1.8--5.3-fold more frequently among those revaccinated with the dermal vaccine than among those revaccinated with the tissue culture vaccine. Thus, the tissue culture vaccine used epicutaneously was as good as the dermal one by the take rate and antigenic activity, but had less remarked reactogenic properties which allows to recommend it for public health practice.

[Results of studying a live mumps vaccine from strain L-3 manufactured by the Moscow Research Institute of Viral Preparations. The epidemiological effectiveness of the vaccine]. / Rezul'taty izucheniia zhivoi parotitnoi vaktsiny iz shtamma L-3 proizvodstva Moskovskogo nauchno-issledovatel'skogo instituta virusnykh preparatov. Epidemiologicheskaia éffektivnost' vaktsiny.

A controlled experiment was carried out to study the epidemiological effectiveness of live mumps vaccine from the L-3 strain, the importance of urgent prophylaxis by vaccination in mumps foci and to evaluate the economic effectiveness of mass prophylaxis of mumps by vaccination. The observations involved 113,967 children of 1 to 12 years. Vaccinations were given to 51,701 subjects and 62,256 subjects were the control group. The groups were formed by random selection. One vaccination dose contained 10(4)HAdU50 of mumps virus. The results attest to high epidemilogical effectiveness of the mumps vaccine. The incidence of mumps among the vaccinees was 29.7-fold lower than among unvaccinated, and the coefficient of protection was 96.6%. The urgent vaccination vaccination prophylaxis carried out in children's institutions during the period of introduction of mumps arrested the outbreak within one month, nad the duration of quarantine was reduced 2-3-fold. As a result of the vaccination the economic effect of 290,000 roubles was achieved.

[Study of the properties of a tissue smallpox vaccine manufactured by the Moscow Research Institute of Viral Preparations]. / Izuchenie svoistv tkanevoi ospennoi vaktsiny proizvodstva Moskovskogo nauchno-issledovatel'skogo instituta virusnykh preparatov.

The tissue culture vaccine against smallpox has some important advantages over the dermal preparation: it is free from bacterial contamination, contains no serum proteins, and suitable for intradermal inoculation with jet injections. The virus for the tissue culture smallpox vaccine is grown in Japanese quail embryo cultures controlled for the absence of contaminating viruses. In trials of the tissue culture smallpox vaccine in 800 revaccinated volunteers no untoward reactions or complications were observed. The antigenic activity of the tissue culture smallpox vaccine was superior to that of dermal vaccine used in the same dose: the geometric mean neutralizing antibody titre after vaccination with the tissue and dermal preparations was 1 : 256 and 1 : 158, respectively, and the antibody rise was 4.5- and 2.5-fold.

[Results of studying a live mumps vaccine from strain L-3 manufactured by the Moscow Research Institute of Viral Preparations. The reactogenic and antigenic properties of the vaccine]. / Rezul'taty izucheniia zhivoi parotitnoi vaktsiny iz shtamma L-3 proizvodstva Moskovskogo nauchno-issledovatel'skogo instituta virusnykh preparatov. Reaktogennye i antigennye svoistva vaktsiny.

The reactogenic and antigenic properties of live mumps vaccine from the L-3 strain were studied in 1507 children of 1 to 12 years of age. A single injection was given, one immunizing dose containing 10(4)HAdU50 of mumps virus. The live mumps vaccine from the L-3 strain irrespective of the lot of preparation, kind (live or lyophilized), method of application (jet-injector or needle/syringe), age of the vaccinees and the amount of virus in the immunizing dose received by a vaccinee, was demonstrated to be practically areactogenic and markedly antigenic. Serological examinations by neutralization tests of 346 paired serum specimens established variation in seroconversion between individual lots to be within 62.5--82.3% (average 69.9%) of cases. Comparative studies on the postvaccination and postinfection immunitiy in mumps showed the level of antibody in the vaccinees to vary within 4.2--5.1 log2 in different years, and in convalescents within 5.1--5.9 log2 in the same years. The results indicate a sufficiently high and intensive immunity for 5 years (the observation period).