The scientists, from Russia's Influenza Research Institute (RAMS) recently completed a preclinical study on intranasal formulation, with encouraging results. Clinical studies are due to start this autumn, and the vaccine will follow in the footsteps of a rival intranasal flu vaccine, MedImmune's FluMist, which is already on sale in the USA.
The adjuvant used in the vaccine, called Korauban, is an immunostimulant gamma interferon inductor that is closely related to ordinary cellulose. The initial clinical candidate form will include antigens from three inactivated viruses (A1, A2, B). An undisclosed component, permitting 12-month tablet stability, will be used to develop a vaccine in tablet form, said a spokesperson for RAMS.
"The combination of Korauban and vaccine viruses in one preparation leads to a synergy of their action," said Professor Oleg Kuznetsov, RAMS project manager.
This is displayed in an increase in early synthesis of common interferon, a factor of the synthesis of intensified non-specific resistance of the organism of bacterial and viral infections."
While adjuvants such as alum have been used in vaccines for decades, there has been interest of late in the development of newer adjuvants that offer more potent or selective immune stimulation. For example, around two-thirds of GlaxoSmithKline's vaccines in development are formulated with new proprietary adjuvant technologies.
Although, FluMist has been on the market since 2003, it remains a minor player compared to injectable flu vaccines, mainly because a requirement to store it frozen makes distribution and administration more complicated. Earlier this month the company won US approval to sell a new formulation that only needs refrigeration, and MedImmune is hopeful this will kickstart sales. It sold 1.7 million doses of FluMist in the first nine months of 2006, bringing in $18 million in revenues.
Now, the Russian scientists are looking for funding of around $600,000 from investors to develop their technology, although the spokesperson said they may decide to sell it if the right offer is made.
The International Science and Technology Centre (ISTC), a non-profit non-commercial organisation based in Moscow, supports the flu project.