Pioneering meningitis nose drop trial planned

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Our researchers are pioneering the use of a nose drop containing a type of ‘friendly’ bacteria that could help prevent meningitis and other infections.

Professor Robert Read, director of our NIHR Southampton Biomedical Research Centre, and his team have applied to a government body to trial the use of a  harmless bacterium with an inserted gene in tackling meningococcal meningitis.

A deadly disease

Meningitis occurs in people of all age groups but infants, young children and the elderly are most at risk. Meningococcal meningitis, which is a bacterial form of the disease and is responsible for 1,500 cases a year in the UK, can cause death in as little as four hours from the onset of symptoms.

Around 10% of adults carry Neisseria meningitidis – the cause of meningococcal meningitis – in the back of their nose and throat with no signs or symptoms.

However, in some people, this bacterium can invade the bloodstream and cause the life-threatening symptoms including meningitis (inflammation of the brain’s outer membrane) and blood poisoning, known as septicaemia.

Helping ‘friendly’ bacteria help us

In a previous study, the Prof Read’s team studied the effects of  introducing into adults’ noses a ‘friendly’ bacterial strain, known as Neisseria lactamica (Nlac), on the populations of its close cousin N. Meningitides (Nmen). Their results showed Nlac settling harmlessly in the nose for months and preventing N. meningitidis from occupying the nose in ~60% of participants.

They now hope genetically enhancing the bacteria with a ‘sticky’ surface protein from Nmen will increase the ability of Nlac to reside in the nose and at the same time induce immunity against the meningitis bacteria.

If successful, this would offer the potential to prevent the spread of infection or the ability to rapidly control an outbreak as meningococcal meningitis cannot develop in the absence of N. meningitidis

Existing therapy, first ever trial of its type

Using friendly bacteria to tackle infections, known as ‘bacteriotherapy’, is already part of some care of inflammatory bowel disease and Clostridium difficile infections.

However when clinical trials of the nose drop begin at the NIHR Southampton Clinical Research Facility, it will be the first time a genetically modified bacteria has been used to prevent infections that develop in the nose and throat.

“We have already shown that placing Nlac in the nose of healthy adults caused no harm to the volunteers, the bacteria settled and it caused an immune response which we believe could prevent the acquisition of harmful bacteria,” said Prof Read, who is a professor of infectious diseases at the University of Southampton.

“Now, following extensive work in the laboratory, we have developed a nose drop which includes Nlac that has been enhanced with a gene to help broaden its effect to, we hope, exclude N. meningitidis.”

Prof Read, who is also an honorary consultant at University Hospital Southampton NHS Foundation Trust, added: “The next stage of this process is to test the drops on healthy volunteers in a clinical trial to ensure the strain of bacteria we have created is going to stay and grow in the nose.

“If successful then we will have a future therapy that we can adapt to combat other diseases caused by bacteria that breed in the nasal pathway, such as pneumonia or ear disease.” 

Public consultation and information

As a first step in the process, Prof Read and his research team have applied to the Department for Environment, Food and Rural Affairs (DEFRA) for permission to use the genetically-modified drop in volunteers. DEFRA are keen to hear from anyone with views or concerns - more details on how to do this can be found here.

It is hoped the study, being run in collaboration with Public Health England and funded by the Medical Research Council, will be underway by the end of the year.

Posted on Monday 31 July 2017