The Crohn’s MAP Vaccine is being developed and commercialized by hav-vaccines.com
The first component of the vaccine has been successfully GMP manufactured by scientists at the Jenner Institute, Oxford at their Clinical BioManufacturing Facility:
The second component of the Vaccine is being GMP manufactured by a company in Germany; manufacture is currently ongoing. The cost of manufacture and Phase I trials – approx £1.4million – has been funded by the company HAV Vaccines Ltd who own the intellectual property rights to the Vaccine.
HAV Vaccines Ltd are seeking investments of a further £1.2million to fund Phase IIa trials. Companies or individuals interested in investing should contact Mr Michael Stallibrass (Email: firstname.lastname@example.org) for more information.
Prof. Hermon-Taylor, together with Dr Tim Bull and other members of the team at St George’s University of London and scientists at the Jenner Institute University of Oxford, developed a modern DNA vaccine against MAP. This took 10 years and cost around £850,000, much of it donated by the families of Crohn’s patients, without whom this new vaccine would not exist. The key features of the Vaccine are:
- Treatment: Modern vaccines can be used to treat, as well as prevent, established chronic infectious diseases. If the vaccine works as well in humans as it does in cattle then there is hope that it could cure, or significantly attenuate Crohn’s Disease. However, it may take time for inflammation to settle and the gut to heal after vaccination in people with longstanding Crohn’s. The vaccine would not be expected to reverse established scarring, such as strictures, at sites of previous active disease.
- Prevention: The vaccine could be given to those at higher risk of developing Crohn’s Disease (e.g. children of those with Crohn’s) to prevent them from ever getting the disease. It could also be given to domestic livestock to prevent MAP getting into the food chain in the first place. Although this would not eradicate exposure completely (MAP still exists within the environment) it could dramatically reduce human exposure.
- Mechanism of action: The vaccine is what is called a ‘T-cell’ vaccine. T-cells are a type of white blood cell -an important player in the immune system- in particular, for fighting against organisms that hide INSIDE the body’s cells –like MAP does. Many people are exposed to MAP but most don’t get Crohn’s –Why? Because their T-cells can ‘see’ and destroy MAP. In those who do get Crohn’s, the immune system has a ‘blind spot’ –their T-cells cannot see MAP. The vaccine works by UN-BLINDING the immune system to MAP, reversing the immune dysregulation and programming the body’s own T-cells to seek out and destroy cells containing MAP.
- Efficacy: In extensive tests in animals (in mice and in cattle), 2 shots of the vaccine spaced 8 weeks apart proved to be a powerful, long-lasting stimulant of immunity against MAP. To read the published data from the trial in mice, click here. To read the published data from the trial in cattle, click here.
- Safety: There were no apparant adverse effects from the vaccine in either of the animal trials. Obviously the vaccine still needs to be tested in humans… but because it is highly specific, targeting only MAP and MAP-containing cells, we would predict that the safety profile in humans is likely to be very similar to that in animals.