ANALYSIS OF THE QUALITY OF NATIONAL VACCINE AGAINST RUBELLA.

Until recently Rubella has been a wide spread infection. Thanks to vaccination against rubella, taking part in the global elimination program of "manageable infections" of WHO and adoption of the program "Elimination of measles and rubella in Russian Federation" the morbidity index of rubella has reached the sporadic level. One of the determining conditions of rubella elimination is application of high-quality vaccines that satisfy international standards. In Russian Federation, foreign rubella vaccines certified in our country were used for several years. In 2008, the commercial production of domestic vaccine began. It is widely known that the required quality of immunobiological medications is achieved using adequate production conditions and standard technological process. That is why during the production of domestic rubella vaccine, all the rules and requirements of Russian regulatory authorities and international recommendations are followed. In this article, a retrospective analysis of domestic vaccine against rubella according to laboratory options of quality in 2012-2017 is given. The results of the analysis show that the medication demonstrates stable high quality that is indicative of secure production technologies.

[A study of the safety of probiotic bacilli].

The aim of the study was to evaluate the biological safety of a range of probiotic bacilli, ingredients of the commercial preparations biosporin, bactisubtil, and irilis; their biological effects were scrutinized in an animal experiment. The study demonstrated that the strains B. subtilis 3, 07, and B. licheniformis 31, 09, ingredients of biosporin and irilis, unlike B. cereus IP 5832, an ingredient of bactisubtil, were not toxic, toxigenic, or virulent, and did not impair the antitoxic hepatic function, which allows considering them to be safe.

[Residual neurovirulence of the chimera of Langat and Denge-4 flaviviruses in intracerebral infection of monkeys].

The residual neurovirulence of the previously obtained chimeric virus Tp21/DEN4, containing the RNA region encoding the pre M and E structural enzymes, strain Tp21, virus Langat, and the remaining part of the genome from the Denge 4 virus, was studied in experiments with monkeys Cercopithecus aethiops involving the intracerebral administration of the virus. The tick-borne encephalitis virus, strain Absettarov, was used as positive control. A comparative analysis of the experimental and published data showed the chimeric virus to be less virulent by its degree of morphological affection in the CNS zones, its spread into the CNS and by a percentage share of animals with viremia versus the Tp21 parent strain and Elantsev strain of the Langat virus.

[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.

[Enteroviral persistence in eye infections in monkeys (postuveitis syndrome)]. / Enterovirusnaia persistentnaia infektsiia glaza u obez'ian (postuveitnyi sindrom).

Follow-up (5.5 years) of monkeys with a history of acute enterovirus uveitis (AEU) after intraocular infection with ophthalmotropic ECHO 11 and ECHO 19 strains showed progressive changes in the infected eye; destruction of the iris, formation of films in the anterior chamber of the eye, deformation of the pupil, and signs of cataract and glaucoma. A short (1-30 days) stage of active reproduction of infective virus (up to 10(10) TCD50/g tissue in the first days postinfection) was followed by the second very long stage of limited specific multiplication of virus in ocular tissues. The virus was not detected during the second stage, but its components (virusspecific antigen and crystalloid accumulations of virions) were found in ophthalmic and conjunctival tissues; moreover, high levels of neutralizing antibodies were detected in the blood. The results indicate AEU transformed into a stubborn persistent infection of the eye in monkeys. The findings of this follow-up and published reports about many-year follow-up of children with AEU permit us to classify a post-uveitis disease as a special nosological form of a persistent enterovirus infection and denote it as enterovirus post-uveitis syndrome. The main signs of this syndrome are a history of AEU, progressive destructive changes in the anterior segment of the eye, presence of virus components in ocular tissues in remote periods after infection, and high antibody level in the blood.

[Safety of bacteria of the genus Bacillus, forming the base of some probiotics]. / Izuchenie bezopasnosti bakterii roda Bacillus, sostavliaiushchikh osnovu nekotorykh probiotikov.

The study of the safety of bacillary strains forming the base of new probiotics (biosporin and subalin) was made. For control, the safety of Bacillus sp. IP5832 (the base of the preparation of bactisubtil) was studied. The results obtained in this investigation demonstrated that the strains contained in biosporin and subalin were safe when injected intravenously and intraperitoneally into animals in dose of 5 x 10(9) cells per 0.5 ml of physiological saline. The introduction of Bacillus sp. IP5832 in the same dose produced 100% lethal effect.

[Superacute lethal liver necrosis in monkeys infected with highly pathogenic variants of enteroviruses (ECHO 11 and ECHO 19 viruses)]. / Sverkhostryi letal'nyi nekroz pecheni u obez'ian, infitsirovannykh vysokopatogennymi variantami énterovirusov (virusy ECHO 11 i ECHO 19).

The authors studied the phenomenon of superhigh virulence for monkeys of viruses ECHO 11 (E11) and ECHO 19 (E19) isolated in 1981-1991 in Russia and Tadzhikistan from children with acute enterovirus uveitis or severe enterovirus infection. In 21 morphologically examined animals after coma, macrofocal or total necrosis of hepatocytes in weak inflammation was seen as early as experiment day 1-6. Hepatic lesion interpreted as hepatosis underlies acute hepatic failure with lethal outcome. The most intensive reproduction of viruses E11 and E19 occurred in the liver. Changes in the kidneys, lungs, spleen, adrenals, CNS detected in many animals aggravated the disease, but were not the primary cause of death. The disease in monkey was similar by the main criteria to superacute lethal diseases (acute hepatic failure against massive hepatic necrosis, hemorrhagic syndrome) registered in outbreaks of E11 and E19-virus infection in children in the USA, Great Britain, Israel, Russia and Ukraine. Monkeys can be used as man-adequate model for study of enterovirus superacute lethal necrosis of the liver.

[The CNS lesion in monkeys spinally infected with the vaccinal poliomyelitis virus]. / Porazhenie TsNS obez'ian pri spinal'nom zarazhenii vaktsinnym virusom poliomielita.

Specific features of the CNS lesions in monkeys inoculated with a vaccine poliovirus strain were studied in comparison with those developing after inoculation with virulent strains. The lesions in the lumbar cord and other regions of the brain and spinal cord after intraspinal inoculation of the vaccine virus are described at length. Certain signs reflecting the specific nature of the lesions were observed. The results of histopathological and immunofluorescent studies were shown to be important for differentiation of specific and nonspecific lesions.