The US drug company ImmusanT, after worldwide trials, is ready to start clinical trials of a new vaccine against celiac…
The US drug company ImmusanT, after worldwide trials, is ready to start clinical trials of a new vaccine against celiac disease at the Royal Melbourne Hospital Clinical Trials Center in Melbourne. This will be followed by attempts held in Adelaide, Brisbane, Perth, Mackay and the Sunshine Coast, says the sources.
Celiac disease – normal villi and wild atrophy. Image Credit: Designua / Shutterstock
The injectable vaccine developed approximately eight years earlier in Melbourne and has been shown to be safe in the first trials with a small number of participants. The disease is basically an excessive immune response to the intestines against food-based allergens such as gluten. Among patients with celiac disease, these allergens lead into food to severe allergic reactions leading to gastrointestinal disorders. There are currently about 160,000 Australians living with celiac disease and have to live on diets that completely lack gluten to prevent weakening symptoms. This means that about 1 in 70 Australians now live with celiac disease, says the researchers who developed the vaccine. Gluten is a protein component found in certain grains, such as rye, wheat and grains.
This new vaccine called Nexvax2 can reprogram the immune response to gluten. This prevents and relieves the symptoms. It was developed at Walter and Eliza Hall Institute of Medical Research (WEHI). The team found three peptides in the gluten that usually trigger the symptoms in 90 percent of the cases and created the vaccine against these peptides.
For this latest phase 2 clinical trial, approximately 50 patients from all over Australia, New Zealand and the United States were to be recruited. They should be given injections of the test vaccine or placebo twice a week for four weeks. Patients would not know which of the two (vaccine or placebo) they received. Then the trial participants would face three food challenges to see if they were given symptomatic relief. Protective effects of the intestinal wall lining would be tested by taking a biopsy of the internal walls of the intestines.
The team explains that the vaccine can prevent excessive susceptibility to the immune cells of the intestinal tract in susceptible individuals. Thus, these T cells do not enter attack mode when they encounter gluten. According to vaccine developers, it may be beneficial for up to 90 percent of patients with HLA-DQ2 disease.
Vaccine developer led by Dr. Jason Tye-Din, from WEHI and Royal Melbourne Hospital, explained that there have been national and international Phase 1 attempts where they looked at the highest possible dose of the vaccine and still found it safe and well tolerated. Dr Tys-Din said, “It also showed a intended biological effect on the immune system in patients with celiac disease. The phase 2 studies are based on data from previous studies and it is amazing that Australia still plays a key role in this work.”
“A successful therapy that can restore normal gluten tolerance would revolutionize cold-cell disease management,” he said.
A list of hospitals where the trial should be conducted can be found at www.coeliac.org.au