Seek

FLU-V: A ground-breaking universal influenza vaccine

SEEK has applied its leading breakthrough technology to the development of FLU-v, the first of a new class of T cell vaccines that are anticipated to be effective against the highly-mutagenic influenza virus. FLU-v has been developed to provide a single vaccination which is effective against all strains of flu virus, including pandemic strains.

Limitations of current vaccines

Mutation and genetic changes (“antigenic drift”) of circulating influenza viruses result in existing vaccines becoming ineffective after a relatively short period of time – indeed, they are referred to as “annual vaccines”, reflecting the need to reformulate and revaccinate individuals at the beginning of each influenza season. This can prove to be costly and inefficient. In addition, reformulation can only take place when the new circulating strain has been identified; vaccine manufacture is, by definition, a response to an influenza outbreak rather than an anticipation of it.

Also, current vaccines are manufactured by egg culture, a complicated and costly procedure that also carries the risk of inducing allergic reactions when injected into individuals sensitive to egg proteins.

Why FLU-v is different

Using a novel predictive technique, SEEK has successfully identified small proteins (which can be synthetically manufactured) to which the immune system will react, in regions of the influenza flu virus that have not changed over 60 years (in either human or animal strains); and has developed a novel vaccine to target them. By targeting these reactive small proteins that are in ever-present or “conserved” regions of the virus, the vaccine is intended to provide long-term protection against the threat of emerging strains, eliminating the need for an annual vaccination.

Unlike traditional vaccines, which are grown in highly-specialised facilities and whose production is limited by egg supply and the process of growing a vaccine, FLU-v can be quickly and easily manufactured in chemical plants. This will allow the vaccine to be made and administered in large quantities prior to a pandemic outbreak, enabling a large proportion of the global population to be protected.

Clinical trials prove safety and cross-reactive immunity to a range of influenza viruses

Following a Phase I safety and tolerability study completed and presented at the World Influenza Congress in December 2010, a Phase II study to examine the safety, tolerability and protective efficacy of FLU-v in an influenza challenge was completed.^{1, 2} In results presented at the Influenza Congress 2011 in Arlington, Virginia, USA in November 2011, vaccinated subjects showed significantly lower symptom scores and viral titre levels compared with non-vaccinated subjects. In addition and most critically, blood from vaccinated subjects showed a cross-reactive immunity to a range of influenza viruses including both animal and human A and B strains. This demonstrates a significant breadth of response and the potential of a universal vaccine to protect people against both annual flu and pandemic strains. FLU-v was well tolerated.

Influenza

Influenza is a common human disease that spreads around the world in seasonal epidemics and affects 5 to 15% of the population annually. These epidemics are thought to result in between three and five million cases of severe illness and between 250,000 and 500,000 deaths every year. The current viruses causing this disease are divided into two groups, A and B, and these can be further subdivided by their surface antigen components.

Major mutations in the antigen components of the virus can result in global pandemics, such as the outbreak of “Spanish flu” in 1918-1919, “Asian influenza” in 1957, “Hong Kong influenza” in 1968 and the H1N1 pandemic in 2010. There is also current concern about the potential transmission of an avian A (H5N1) strain to humans. However, even minor genetic changes require the annual reformulation of currently-used vaccines and the necessity of re-inoculating at-risk individuals. Antigenic drift applies to both type A and B viruses. There is therefore a significant need for an influenza vaccine that will be protective against a range of strains of the virus and which can confer long term immunity.

FLU-v is designed to protect against both type A and B viruses, as well as antigenic drift within each virus type.

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