HAV002
Research type
Research Study
Full title
A clinical trial to determine the safety and immunogenicity of the candidate Mycobacterium avium subspecies paratuberculosis (MAP) vaccines ChAdOx2 HAV and MVA HAV in patients with active Crohn’s disease
IRAS ID
262209
Contact name
Jeremy Sanderson
Contact email
Sponsor organisation
HAV Vaccines Ltd
Eudract number
2018-003462-14
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Crohn's disease is a long-term condition that causes inflammation of the lining of the digestive system. Common symptoms can include: diarrhoea, abdominal pain, extreme tiredness, unintended weight loss, blood and mucus in the faeces. Over time, inflammation can damage sections of the digestive system, resulting in complications such as narrowing of the intestine, or a channel developing between the end of the bowel and the skin near the anus or vagina (fistula). These problems usually require surgical treatment and health care costs are substantial. There's currently no cure for Crohn's disease, so the aim of treatment is to stop the inflammatory process and relieve symptoms.
Mycobacterium avium subspecies paratuberculosis (MAP) belongs to a class of microbes called mycobacteria which cause diseases such as tuberculosis and leprosy. The microbe can be found in the environment and is known to cause a very similar chronic bowel disease in cattle. The scientific evidence suggests it can also play an important role in the development of Crohn’s disease in humans. A vaccine against MAP could potentially lead to significant clinical improvement of Crohn’s disease.
The purpose of this study is to assess two parts of the new MAP vaccine, the initial “prime” ChAdOx2 HAV vaccine and the “boost” MVA HAV vaccine, at different doses in patients with active Crohn’s disease. If the results from this first part of the trial show that the vaccines are safe, we will then give some patients both the “prime” ChAdOx2 HAV vaccine and the “boost” MVA HAV vaccine The study will enable us to assess the safety of the vaccines and the extent of the immune response in patients with active Crohn’s disease. We will do this by giving participants the vaccine/s in addition to doing blood tests and collecting information about any symptoms that occur after vaccination.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1738
Date of REC Opinion
19 Dec 2019
REC opinion
Further Information Favourable Opinion