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Influenza Vaccines

#0940


Development of the Culture Influenza Vaccine

Tech Area / Field

  • MED-VAC/Vaccines/Medicine

Status
8 Project completed

Registration date
07.04.1997

Completion date
02.09.1999

Senior Project Manager
Kondratenkov Yu B

Leading Institute
State Research Center of Virology and Biotechnology VECTOR / Institute of Molecular Biology, Russia, Novosibirsk reg., Koltsovo

Supporting institutes

  • Research Institute of Viral Preparations, Russia, Moscow

Collaborators

  • Vanderbilt University, USA, TN, Nashville\nBaylor College of Medicine, USA, TX, Houston\nCenters for Disease Control and Prevention (CDC), USA, GA, Atlanta

Project summary

Influenza is known as one of the most widespread human infectious diseases with considerably high lethality rate especially for elderly people. The presently existing vaccines against influenza are able to protect about 80 % of the vaccinated people, the proper administration provided. However, the mass prophylaxis with these vaccines is hindered by their high price due to the complexity of the production and expensiveness of the substrate used for vaccine production (chick embryos) along with the necessity of subcutaneous or intramuscular administration. Development of the production technology of a cheap and easily administered influenza vaccine suitable for mass prophylaxis of influenza is, thus, a topical problem. The live influenza vaccine produced on cell culture may represent the vaccine, which meets the above requirements. Such vaccine will be more standard, cheap, easily administered (intranasally) preparation as well as more innocuous since a lot of people exhibits allergic reaction to the proteins of allantoic liquid of chick embryos. However, human influenza viruses poorly propagate in cell cultures; thus it is necessary to perform the special purpose investigations to develop the cultivation conditions of the cells and influenza virus which will provide the virus propagation up to the titers sufficient for production of the influenza vaccine.

Some years ago the live attenuated cold-adapted recombinant influenza vaccines for influenza prophylaxis in children and adults was developed with participation of the Institute for viral preparations, however these vaccines are now produced only using chick embryos.

The main goal of the present Project is the development of production technology of the live cultural cold-adapted influenza vaccine with the detailed determination of the optimal cultivation conditions for cells and viruses, first in laboratory-scale fermenter and then in commercial-scale fermenter; production of pilot batches of the vaccine and their certification considering their immunogenicity and innocuousness in laboratory animals. Noteworthy that so far the live cultural influenza vaccine has been never developed and produced. Thus, both technological design and the preparation of the cultural live influenza vaccine itself are novel.

If positive results will be obtained in development of technology of production of live influenza vaccines on cell line the data obtained will be used for development of cultural inactivated influenza vaccines.

Major objectives of the investigations within the proposed Project are the following:


- selection of the continuous cell culture which provides the maximum accumulation of the vaccinal cold-adapted influenza virus strains;
- optimization of the cultivation conditions for the chosen cell line in laboratory-scale fermenters;
- optimization of the conditions for vaccinal strains reproduction in the chosen cell line in laboratory-scale fermenters;
- optimization of the propagation conditions for the chosen cell line in commercial-scale fermenters;
- preparation of the inoculation and working banks of the cell culture and their certification for production of immunobiological pre parations in the L.A. Tarasevich SISC;
- optimization of the conditions for reproduction of influenza virus vaccinal strains in the commercial-scale fermenter;
- molecular-genetic analysis of stability of the genetic traits and mutations responsible for attenuation of the influenza virus vaccinal strains grown in laboratory- and commercial-scale fermenters;
- optimization of the lyophilization and stabilization condition of the live cultural cold-adapted influenza vaccine;
- production and certification of the pilot batches of the live cultural cold-adapted influenza vaccine;
- control of immunogenicity and innocuousness of the pilot batches of the vaccine in laboratory animals.

Topicality and scientific novelty of the present Project consists in the development of production technology of the live cultural influenza vaccine for intranasal administration. The proposed technology will provide more cheap, standard, and easily administered vaccine. It is of prime importance that the technology is autonomous and independent of the availability of leukosis-free chick embryos.

Production technology of the live cultural influenza vaccine will be of commercial value; organization of the large-scale production of the vaccine will be performed in the SRC VB "Vector" with participation of RIVP.

Potential role of the foreign collaborators:

Exchange of scientific data within the Project, estimation and discussion of the results obtained.


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