Thursday, 11 August 2016

Potentially Pandemic Live Influenza Vaccines Based on Russian Master Donor Virus are Genetically Stable after Replication in Humans

Birds and Mammals are the main reservoir of newly emerging pandemic influenza viruses [1-3]. Global circulation of influenza A viruses in avian species poses a constant threat to human public health. Vaccination remains the main strategy against influenza. Over the last decade, the interest in the live attenuated cold-adapted reassortant influenza vaccine (LAIV) has increased dramatically. To a large degree, it is because World Health Organization (WHO) recognized the advantages of LAIV in the event of pandemic situation. For instance, needle–free administration, high vaccine virus yield, easy down– stream processing, cross–reactivity of immune responses etc. make LAIV very attractive preparation in the face of pandemic situation.

Genetic stability and the absence of transmission potency are the main properties of LAIVs, which guarantee their safety. Confirmation of genetic and phenotypic stability is one of key points of characterisation of LAIV, which is especially important in pandemic situation to guarantee its safety profile during large–scale immunization campaigns.

 In each of those studies, 38-40, 18-49 years old participants both sexes were randomly assigned to receive two doses of vaccine or placebo at a 3:1 vaccine:placebo ratio. Vaccine and placebo were administrated intranasally. The preclinical studies, as well as safety and immunogenicity of these three LAIVs for use in the pandemic situations were earlier well documented and published. In this paper, we presented the results of molecular genetics and virological studies conducted as a part of phase I clinical trials. In particular, shedding, transmission and genetic stability of H7N3, H5N2 and H2N2 LAIVs against pre–pandemic influenza viruses were studied.

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