Crohn's MAP Vaccine Summer 2018 newsletter View this email in your browser Research update

Vaccine Trials Progress: Phase 1 Safety Trial in healthy volunteers (people who do not have Crohn's disease)

The Jenner Institute Clinical Trial of the safety of ChAdOx2 HAV, the priming shot of the 2 shot vaccine, was completed at Oxford University last year. It proved very safe and was well tolerated by the volunteers, which is great news. Based on this, the Jenner team applied to the regulators and got permission to add the booster vaccine to the Clinical Trial, without having to submit a whole new trial for consideration by the authorities (this saved about 6 months’ work and significant costs). This final stage of the phase 1 Clinical Trial, using the second component vaccine, MVA HAV, is due to begin in August and finish around the beginning of next year.



Phase 2 Clinical Trial in people with Crohn's disease

The Phase IIa trial is currently in the set-up phase at Guy’s and St Thomas’s Hospitals with a lot going on behind the scenes. As previously mentioned, the set-up period in clinical trials is often unpredictable. It has taken us longer than we originally hoped to get the right team in place and the many approvals applied for and regulations complied with. However, we have built a strong team and the work is now progressing steadily. We currently estimate that the trial will start recruiting patients around the end of 2018.



We can tell you that the trial will be conducted in 12 patients with mild Crohn's Disease (with a positive test for MAP) aged between 18-50 years who are not taking any immunosuppressant medications or biologics and are resident in the UK. The trial will be a near exact copy of the Phase 1 Clinical Trial in Oxford and will concentrate again, as required, on Safety and Immunogenicity. We will be using our new MAP test to assess MAP levels before and after vaccination. Further details of the eligibility criteria will be published online when the trial opens for recruitment. Please note that recruitment has not yet started, so we therefore ask our supporters not to contact us or St Thomas’ Hospital about this.

MAP test update Validation studies

The final experiments to complete the validation work are now being conducted. This section looks at our MAP blood test which uses MAP-specific monoclonal antibodies in a Flow Cytometry assay to tell you what % of white blood cells contain MAP. To prove that the test is accurate, we then separate the cells into 2 tubes, one containing the cells that are positive for MAP and the other containing the cells that are negative. These tubes will then be further analysed by PCR; we hope to show that the cells positive for MAP by our method are also positive for MAP by PCR and vice versa -thus confirming the specificity of our test.



Sections of this body of work which have already been completed are currently being prepared for publication.



Poster presentation: Detection and Isolation of MAP from skeletal muscle tissue of 143 cattle at a German abattoir



Neil Rayment, our senior research scientist, attended the International Colloquium on Paratuberculosis in Mexico in June 2018. He presented a poster on a study we are doing in collaboration with Veterinary scientist Heinrich Dahmen (Germany) and his team. The study looked at muscle biopsies taken from cattle with clinical Johne’s disease (Inflammatory Bowel Disease due to MAP infection) to look for the presence of MAP in the muscle. Two methods of MAP testing were compared: standard culture and PCR vs our new MAP tissue test (immunofluorescent staining using MAP-specific monoclonal antibodies). This is important as muscle is meat which will be potentially entering our food chain!... and ultimately, we need to ensure that MAP is eliminated from our food chain entirely.



The following is a lay summary of the study so far:



Method:

Official meat inspection at a German abattoir identified 143 cattle with signs of clinical Johne’s disease, subsequently confirmed to be due to MAP infection. 5 healthy animals who were negative for MAP were used as controls. Muscle biopsies from all the cattle were analysed by culture and PCR. Muscle biopsies from 95 of the MAP-positive cattle and the 5 MAP negative cattle were analysed using our new MAP tissue test.



Results: Using culture and PCR: Muscle biopsies were positive for MAP in 39% (56/143) of MAP-infected cattle and negative for MAP in the 5 healthy cattle

Using our MAP tissue test: Muscle biopsies were positive for MAP in 97% (92/95) of MAP-infected cattle and negative for MAP in the 5 healthy cattle. Images of muscle biopsies staining positive for MAP are shown in Figure 1 below. Conclusion:

The results suggest that presence of MAP in muscle tissue (and hence in meat entering our food chain) could be much higher than was previously thought. Fundraising Thanks to the continued efforts of the Crohn’s MAP Vaccine community, the fundraising total stands at £681,647 as of June 2018, with around £50,000 raised in the first six months of 2018. There have been some really creative and challenging fundraisers over the past few months, and we would like to thank everyone who has helped with fundraising and raising awareness – we really couldn’t have come so far without each and every one of you!



Here’s a taste of just some of the fundraisers and events which have been happening over the last few months…



In June 2018, Nigel Arbury and his son Daniel undertook “The Wall” challenge. The challenge consists of travelling on foot the entire length of the ancient remains of the Roman Emperor Hadrian’s Wall, which runs from Carlisle Castle to Newcastle – a distance of 69 miles! Nigel attempted the challenge last year with team-mate Garrie Webster, but injury stopped Nigel’s progress three quarters of the way through. Nonetheless he was determined to complete the challenge so entered again this year. Collectively they have raised over £3000 for the Crohn’s MAP Vaccine research.



In June 2018 Anna Sykes and her family held a stall at Cuddington gala day, as they have done in previous years. They had a tombola as well as a “basket of booze” raffle, making a massive £900 and spreading the word about MAP. Thankfully the weather was much kinder to them this year compared to last year!



In June 2018 Nicola and Christopher Thompson ran the Derby half-marathon. This was a particularly challenging event for Nicola as it was her first race since having a baby. It was a VERY hot day but they crossed the finish line after 2 hours, 12 minutes and 57 seconds, and raised over £400 for the Crohn’s MAP Vaccine research. A huge well done to Nicola and Christopher! Canadian law firm Jaques Robert reached their fundraising target of $10,000 in May 2018. Their clients have been very generous with donations and the firm also match any donations received. They now intend to increase their fundraising goal to $20,000 to see if they can raise even more! They said “Our clients have been amazing so we will be increasing our goal to 20K to see if we can do it!”



Our talented Deborah Swallow-Gath cleverly created this book-folding artwork using the Crohn’s MAP Vaccine slogan “I want to be cured not managed”, which she raffled off in May 2018.



Helen Varney organised the fourth annual Black Mountain craft market which took place in April 2018, with all proceeds going to the Crohn’s MAP Vaccine research. Despite a morning of torrential rain £402 was raised, as well as raising much needed awareness. Helen wore her beautiful “Cured Not Managed” t-shirt and handed out flyers with information about the Crohn’s MAP Vaccine work. Helen says next year’s date for the event is already provisionally booked!



On World MAP Day, Ollie Knights played a gig at the London Palladium theatre along with his band Turin Brakes, with Ollie sporting his World MAP Day t-shirt to raise awareness. A donation of £1000 was also made from Leila and Nick, friends of Rachel Knights and Ollie Knights, in addition to a £1000 donation from associates of Rachel Knights who held a gig and donated the proceeds to Rachel’s nominated charity - Crohn’s MAP Vaccine. Rachel and Ollie’s daughter, their little Crohn’s warrior, is pictured below with Ollie on World MAP Day.

Sarah Dawson sold homemade cakes at her work place for Valentine’s Day, World MAP day, and World IBD day. She used a collection tin provided by Kings College London with a Crohn’s MAP Vaccine label (if you would like a collection tin you can find details on how to order one here).

Jackie Gamble (Farr) held “A Night at the Races” in memory of her daughter Jessica who tragically died in July 2016 from Crohn’s. A grand total of £2025 was raised for the Crohn’s MAP vaccine research.



We hope to see more fundraising events taking place over the coming months, and if you would like to get involved in setting up your own fundraiser please get in touch via our website or join our Facebook fundraising and support group. Goodbyes hurt the most when the story was not finished… It is with very heavy hearts that we bring you the devastating news of another untimely death within the Crohn’s MAP Vaccine community. Kylie-Anne Clifford Gillen, the daughter of core team member Christine Clifford, sadly and unexpectedly passed away in April. Kylie had been battling Crohn’s disease for many years and just before her death she had been admitted to hospital where she rapidly deteriorated. Kylie leaves behind her husband Leo and her beautiful 6 year old daughter Emilia Rose. Kylie’s family very kindly requested donations for the Crohn’s MAP Vaccine in lieu of flowers from well wishers, and received in excess of £1800 in donations. Kylie’s funeral took place in May, followed by a memorial service in June.

For Kylie, her family, and for the thousands of others who have lost their lives due to this terrible disease and its related treatments, we will keep up the fight. World MAP day We are very proud to have set up the very first World MAP Day for 15th March. This is a day to raise awareness about all things MAP related, including research into diseases linked to MAP and also the wider issue of its prevalence in the environment. We organised a Thunderclap on social media which 412 people signed up to, all posting at the same time on 15th March. We reached 250,143 people in total! Thank you to everyone who signed up. We’ll aim to do even better next year!



and now you can buy our merchandise! To support both World MAP Day and also World IBD Day on 19th May, we launched our ‘Cured not Managed’ shop! Here you can buy merchandise to show your support for Crohn’s MAP Vaccine. This is a great way to show your support and to raise funds at the same time. T-shirts, device cases, home décor and stationery – shop now at www.curednotmanaged.com and take your pick! Useful links If anyone would like more detail about the fundraising structure of this project, please click here.

For our scientific ‘Core Literature pack’ please click here.

To find out how to become a hero click here.