Despite the progress in fighting against infectious diseases of bacterial origin, the incidence of generalized forms of meningococcal infection (GFMI) remains a topical public health problem not only in countries with historical high incidence, but also in countries considered to be relatively «secured» in regard to the mentioned infection. In the 60s of the last century the production of high-polymer forms of meningococcal polysaccharides was started. These high molecular weight polysaccharides were used for the development of vaccines. They helped to significantly reduce the incidence of GFMI in certain countries, including the countries of the so-called African «meningitis belt». Unfortunately, polysaccharide vaccines have well-known deficiencies, prompting the researchers to develop advanced conjugate vaccines. Current new generation of vaccines are based on conjugates of polysaccharides of different serogroups with carrier proteins such as tetanus toxoid, a modified diphtheria toxin (CRM₁₉₇) or outer membrane proteins. Mono- and multivalent conjugate vaccines were developed and tested. Conjugate vaccines have several advantages compared to the polysaccharide vaccines. They stimulate the formation of immunological memory, and therefore are able to provide consistent protection against meningococcal disease in children of an early age group. In particular, monovalent conjugate vaccine against serogroup C meningococcal disease were proven to be very effective. This vaccine was successfully used in the UK. There are also tetravalent conjugate vaccines Menactra and Menveo. These preparations consist of serotype A, C, W₁₃₅ and Y meningococcal polysaccharide conjugates. These polysaccharides stimulated the production of bactericidal antibodies in 90% of immunized individuals. Certain success was also achieved in developing genetically engineered vaccines and the vaccines based in meningococcal outer membrane vesicles (OMV-vaccines). OMV-vaccines showed to be effective in the fight against epidemics of meningitis caused by serogroup B meningococcus. Polysaccharide vaccines against serogroup B meningococcus in different designs proved to be ineffective because of their low immunogenicity. There are certain difficulties in developing an ultimate vaccine that protects against GFMI, due to the fact that there is a variety of antigenic types of serogroup B meningococcus. So far the scientists only have managed to develop a strain-specific vaccine suitable for fighting GFMI outbreaks, caused by the specific strain of serogroup B meningococcus. The opportunities to enhance the efficacy of vaccines against serogroup B meningococcus are still being discussed.

Adverse drug reactions (ADR) are injuries caused by taking a medication. For the purpose of an objective analysis of the reasons and mechanisms of ADR, with a view to developing the methods for their relief and prevention, one should use standard criteria for the characterization of ADR. Typically, the description of ADR includes information about the damaged organ or tissue and the frequency of ADR occurrence. To characterize ADRs caused by low molecular weight chemicals proposed, an A/B classification and its modifications have been proposed, based on the possible mechanisms of ADR. Biological preparations differ from chemicals by a number of characteristics, including the mechanism of action. Considering the nature of biological/biotechnological preparations, several types of ADR classifications, related to the mentioned drug group, have been suggested. The most popular classification for ADR related to biological preparations have been suggested by W. J. Pichler. It is based on the involvement of immunological mechanisms in ADR occurrence. This classification divides ADR related to biologicals into 5 types: type α (reactions caused by high level of cytokines), type β (hypersensitivity reaction), type γ (reactions caused by the imbalance of immune factors), type δ (cross-reactivity reactions) and type ε (reactions caused by non-immunological mechanisms). The mentioned classification method has certain disadvantages: it does not cover all biological preparations, but only drugs, containing cytokines, hormones and monoclonal antibodies preparations; and it does not consider ADR occurring without immune mechanisms (such as increased blood pressure when administering preparations of recombinant erythropoietins).

The present article summarizes the materials from literary sources dedicated to the issues of laboratory diagnosis of anthrax. It shows the priority of the development of new methods for the elaboration of highly sensitive test systems and preparations designed for the detection and identification of anthrax bacteria. It outlines the role of express-diagnostics of infectious diseases, which is very important when investigating bioterrorism cases, outbreaks and sporadic cases in humans and animals. Providing with the analysis of different methods for detection of anthrax, the article at the same time focuses on modern molecular diagnostic technologies. It is shown that the basic parameters of diagnostic test systems are sensitivity, specificity and reproducibility of the results. The article presents data on the development of culture media for isolation and identification of anthrax, as well as the possibility of using anthrax bacteriophage for phage-based indication and identification of bacteria.

Vaccination is one of the most effective ways to control the epidemic process in a number of infectious diseases. Many years of experience in the use of vaccines proved the undeniable importance of preventive vaccination in the fight against serious diseases such as smallpox, polio, diphtheria, tetanus, measles, pertussis, rubella, mumps and others. The incidence of these infections is dependent on vaccination coverage, which should not be lower than 95%. This rate is hard to be achieved and it is a serious public health problem, since every year we notice a growing number of medical exemption to the immunization in children with various health disorders. Immunization in children of the mentioned group is a significant reserve for increasing the rate of vaccinated population. The article outlines basic scientific and methodological approaches to immunization in patients with health disorders. The authors summarized the experience of domestic researchers and suggested the common tactical methods to engage the mentioned cohort of children for immunization, based on modern scientific and practical achievements in child immunization of high-risk groups. These scientific and methodical approaches can improve the rate of the vaccinated population and therefore protect against infectious diseases, managed by specific prophylaxis.

The purpose of the study was to assess the effectiveness of the removal of nucleic acids (NA), Hepatitis B (HBV) and C (HCV) viruses and parvovirus B19 (B19V) from blood plasma fractions obtained by alcohol separation. The studies were performed in a model experiment by fractionation normal pool plasma donation contaminated with virus-containing samples in the laboratory. It was found that the multi-step process to extract a fraction II, designed to provide the immunoglobulin G, provided the elimination of NA HBV and HCV to undetectable levels by PCR, and the total reduction factor compared to the original composition of the plasma HBV DNA >5.35 log_, HCV RNA >4.84 log. Factor DNA V19V reduction was at the level of 4.56 log(CI 4.49-4.63). Upon receipt of the fraction V (for albumin) reduction factor of the test virus was >3.0 log wich in combination with additional purification step provides a reliable level of safety. The selection fraction I resulted in effectiveness of the elimination of HBV DNA and V19V DNA less than 2 orders, HCV RNA - less than 3 orders of magnitude, it is not enough to recognize the stage reliable. Experiments confirmed that the high risk of contamination of production pools parvovirus B19 additional safety measures are necessary, including mandatory investigation of plasma DNA V19V. In general the development of a full cycle of drug from blood plasma from donors, basic process alcohol fractionation steps necessary to supplement validation virus elimination and inactivation considering residual risk of contamination with pathogenic agents feedstock.

Multiplex polymerase chain reaction method was used to assess the stability of 7 seed lots of a substrain Mycobacterium bovis BCG-1, Russia, used for the manufacture of BCG vaccine since 1948 till present. For performng PCR we used primers, matching 5 parts of the RD field and 1part of repeating elements of intergenic operon senX3-regX3 region. Electrophoregrams of amplification products for 7 seed lots of products were identical and differed from the electrophoregrams of other known BCG substrains used as control samples. Similar results were obtained for genotyping of 32 commercial lots of BCG vaccine, manufactured using substrain M. bovis BCG-1 by three Russian manufacturers. The obtained data confirmed the stability of seed lots of BCG vaccine used for more than 60 years, and the adequacy of the settled system of strain maintanance. The assessed method of multiplex PCR with domestic reagents can accepted for confirming that the seed and the vaccine are identical to domestic BCG vaccine substrain (M. bovis BCG-1) when performing «Identification» test. The mehod is adequate and reproducible.