Unique flu vaccine trial to start in London

With winter on its way and the flu season about to begin Londoners are being offered the opportunity to sign up for a unique clinical trial to test a new DNA Vaccine. The trial, which has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), will test for the first time whether a DNA vaccine can protect people from infection with influenza.

If successful, this challenge study could pave the way for DNA vaccines such as this H3 vaccine for annual flu and PowderMed’s H5N1 pandemic vaccine, to reach market approval. PowderMed also started a trial on the H5N1 DNA vaccine last month.

PowderMed’s Chief Medical Officer, Dr John Beadle said “This particular trial is unique because it will be the first to assess the ability of our DNA vaccine to protect human volunteers against flu. What we are looking for are people willing to be vaccinated and then later challenged with an annual flu virus. Some of them may get a mild form of influenza like illness, but our previous data suggests that those who are vaccinated may be protected. All volunteers will receive, at the end of the study, treatment with Tamiflu a licensed antiviral drug”.

This trial is one of three being conducted this year by UK company PowderMed to assess the ability of DNA vaccines to protect against annual and pandemic influenza. PowderMed’s DNA vaccines use a proprietary needle-free system to deliver microscopic gold particles coated with DNA at supersonic speed into the immune cells of the skin. Previous studies have shown that these vaccines can protect animals from challenges with either annual or bird flu viruses and produce a protective level of immune response in humans.

The first phase of the trial is being conducted at Guys Drug Research Unit (GDRU), Quintiles UK Ltd in London. Dr Tim Mant, Senior Medical Advisor, GDRU said that “Annual flu is debilitating for many and life threatening for some; flu is a major public health issue and we feel it is important to contribute to knowledge about potential new vaccines. We are currently screening volunteers to determine whether they may be eligible to enroll in this influenza vaccine study.”

Later in the trial the volunteers will be accommodated for ten days in a residential facility, where they will be challenged with an enfeebled version of the H3N2 strain of influenza virus which is known to cause annual influenza in non-immunised people. At the end of this period the volunteers will all be given Tamiflu, an antiviral drug, already approved for use in the UK to reduce the duration of any potential influenza symptoms.

Full details of this clinical study and directions for potential volunteers can be found at www.clinicaltrials.gov. Anyone interested, who is otherwise healthy and aged between 18 and 50, should contact Quintiles at Guys Drugs Research Unit on 0800 634 1130.