Vaccine composition for use in immuno-compromised populations

Abstract

The invention relates to nasally-administered vaccine compositions effective against infection in immuno-compromised populations. One aspect of the invention is directed to the pediatric use of the vaccine of the invention including a vaccine effective in children against seasonal influenza virus strains. A further aspect of the invention is directed to subjects of all age groups when the composition is for pandemic use.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]The invention relates to nasally-administered vaccine compositions effective against infection in immuno-compromised populations.[0003]2. Background of the Invention[0004]Influenza vaccines currently in general use are based on live virus or inactivated virus, and inactivated virus vaccines can be based on whole virus, “split” virus, subunit proteins or on purified surface antigens (including haemagglutinin and neuraminidase).[0005]The socioeconomic impact of influenza and its medical burden in immuno-compromised subjects including the elderly has been increasingly recognized. Moreover, immuno-compromised individual's e.g. elderly aged ≧65 years are at greater risk for hospitalization and death form seasonal influenza compared with other age groups. Further, immuno-compromised individuals have high attack rates of influenza during epidemic periods. Unfortunately, immuno-compromised do not respond well to vaccinations. T...

AI Technical Summary

Benefits of technology

[0036]optionally one or more mono-glyceridesfor use as an intranasally administered vaccine for use in immune-compromised subjects for the prevention of infection with Streptococcus pneumoniae or for reducing the severity of symptoms associated with an infection with Streptococcus pneumoniae.

Problems solved by technology

Moreover, immuno-compromised individual's e.g. elderly aged ≧65 years are at greater risk for hospitalization and death form seasonal influenza compared with other age groups.

Further, immuno-compromised individuals have high attack rates of influenza during epidemic periods.

Unfortunately, immuno-compromised do not respond well to vaccinations.

Individuals with sub-optimal immune function due to disease or therapy are recognised to be at increased risk form influenza related complications.

Concerns about influenza within immuno-compromised populations include an impaired response to vaccination and higher risk of complicated infection with increased mortality, greater and prolonged virus shedding with implications for control of transmission and possible adverse effects of vaccination.

Studies have shown that conventional parenteral vaccines have decreased ability to induce satisfactory protective immunity in immuno-compromised individuals compared to the generally immuno-competent population.

Hence, even “mild” influenza pandemics like the influenza A(H1N1) pandemic was associated with substantial mortality in the elderly and immune-compromised.

Because of this, the body's immune system in pregnancy has a harder time fighting off the influenza virus, and the flu therefore tends to be more severe.

Of these, half died—resulting in an astounding and tragic death rate of 25% among pregnant women who got the flu.

The immuno-compromised, especially the elderly or those with underlying chronic diseases, are most likely to experience such complications, but young infants also may suffer severe disease.

In one sense young children can also be considered immune-compromised, as their immune system is not fully developed and does not respond as well as an adult's immune system.

During a pandemic, antiviral drugs will not be sufficient or effective enough to cover the needs and the number of individuals at risk of potentially life-threating influenza disease.

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