Crohn’s MAP vaccine

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Crohn’s MAP vaccine

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Australia

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Perth, Western Australia, Australia

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What is Crohn’s Disease?

Crohn’s Disease is a debilitating and aggressive form of Inflammatory Bowel Disease. It affects around 5 million worldwide, including 1.2 million in the USA and over 100,000 in the UK –and numbers are increasing, especially in children. Symptoms include chronic severe abdominal pain, weight loss, bloody diarrhoea and fatigue. Up to 80% of patients will need surgery at some point in their lifetime. There is currently no cure and the lives of most sufferers are blighted by multiple hospitalisations, surgeries, immunosuppressive therapies (and their side effects) and difficulty holding down a job or attending school.

The Research: Professor John Hermon-Taylor (King’s College London) is an expert in Crohn’s Disease who has been researching its cause for over thirty years. He strongly believes that Crohn’s Disease is caused by a bacterium called Mycobacterium avium subspecies paratuberculosis (MAP) – a distant cousin of Tuberculosis. Controversially, MAP is most commonly passed to humans through cow’s milk. Dr Burrill Crohn (1884-1983) himself, who gave his name to the disease, suspected that Crohn’s might have a mycobacterial cause -but he could not prove it with the scientific equipment of his era. Professor Hermon-Taylor has invented a modern therapeutic vaccine against MAP which he believes holds the best hope of a cure for Crohn’s that there has ever been. It is designed to stimulate the body’s own immune system to selectively eliminate MAP-infected cells. Animal studies in mice and in cattle have shown it to be highly effective against MAP with no obvious adverse effects.

A Phase I trial of the vaccine in healthy human volunteers has now been completed by The Jenner Institute, Oxford. They have allowed us to share this statement about the trial: ‘The Phase I trial was completed with no concerns over safety. As it was the first trial of this vaccine in people, a standard ‘3+3 dose escalation design’ was used to allow us to start with a very low dose for the first few volunteers and then gradually increase the dose once we were sure that there were no safety concerns. All doses were well tolerated, immunogenicity looks very promising and the study is being written up for publication. We would like to thank the healthy volunteers who took part in this Phase I study, without whom it wouldn’t be possible to develop important new therapies.’

A Phase IIa trial of the Vaccine in patients with Crohn’s disease (assessing safety and immunogenicity in CD patients) is due to start shortly.

An essential element of this trial is a ‘companion diagnostic test’ – a simple test for MAP in blood and tissues – on which work is nearing completion at King’s College London. This will allow doctors to tell which patients have MAP and to monitor patients’ responses to the vaccine. The test also enables MAP to be seen in the tissues of people with Crohn’s disease for the very first time – something scientists have been trying to achieve for decades – and may be the making of medical history.

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