[The use of genetic engineering constructions as control samples on evaluation of diagnostic kits for reveal of rna of hazard and extremely hazard agents of virus infections by reverse transcription - polymerase chain reaction.]

The reverse transcription - polymerase chain reaction method (RT-PCR) has leading position on diagnostic infections, caused by RNA-containing viruses. This method presents severe requirements to carrying out of everybody stages of analysis (extraction of nucleic acid, carry out reverse transcription, amplification of DNA). It is necessary to account the possibility of false positive or false negative results appearance. The use on RT-PCR only positive (PCS) and negative (NCS) control samples is insufficient for the control of stages of RNA extraction and reverse transcription. That is way there is necessity the construction of inner control sample (ICS) to control of these stages. The main goal of present is the ground of use genetic engineering constructions (GEC) as control samples (PCS and ICS) on evaluation of diagnostic kits for reveal of RNA of hazard and extremely hazard agents of virus infections by RT-PCR. The vector recombinant plasmids, containing the insertion of cDNA of agent´s genomic RNA are used as PCS, RNA was packed in membrane protein of MS2 bacteriophage, is used as ICS. It is demonstrated that ICS does no influence on sensitivity of RT-PCR both for use of native agents and for use of synthetic nucleic acids of Ebola, Marburg, Lassa, Machupo, Venezuelan encephalitis equine (VEE), Rift Valley fever and rabies viruses. The possibility of use of PCS and ICS for standardization of diagnostic kits is discussed.

Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia.

Ebola hemorrhagic fever, also known as Ebola virus disease or EVD, is one of the most dangerous viral diseases in humans and animals. In this open-label, dose-escalation clinical trial, we assessed the safety, side effects, and immunogenicity of a novel, heterologous prime-boost vaccine against Ebola, which was administered in 2 doses to 84 healthy adults of both sexes between 18 and 55 years. The vaccine consists of live-attenuated recombinant vesicular stomatitis virus (VSV) and adenovirus serotype-5 (Ad5) expressing Ebola envelope glycoprotein. The most common adverse event was pain at the injection site, although no serious adverse events were reported. The vaccine did not significantly impact blood, urine, and immune indices. Seroconversion rate was 100 %. Antigen-specific IgG geometric mean titer at day 42 was 3,277 (95 % confidence interval 2,401-4,473) in volunteers immunized at full dose. Neutralizing antibodies were detected in 93.1 % of volunteers immunized at full dose, with geometric mean titer 20. Antigen-specific response in peripheral blood mononuclear cells was also detected in 100 % of participants, as well as in CD4+ and CD8+ T cells in 82.8 % and 58.6 % of participants vaccinated at full dose, respectively. The data indicate that the vaccine is safe and induces strong humoral and cellular immune response in up to 100 % of healthy adult volunteers, and provide a rationale for testing efficacy in Phase III trials. Indeed, the strong immune response to the vaccine may elicit long-term protection. This trial was registered with grls.rosminzdrav.ru (No. 495*), and with zakupki.gov.ru (No. 0373100043215000055).

[The molecular genetic characteristic of RNA of human enterovirus detected in bio-test from child with serous meningitis].

The article considers molecular genetic characteristic of RNA of human enterovirus detected in bio-test from child with serous meningitis. The nucleotide sequence of genome DNA is analyzed. In 98% it is identical to corresponding nucleotide sequences of strains of human enterovirus A serotype 71 detected in China.