A new clinical trial, led by Prof David Hunt (UK DRI at Edinburgh), is set to test whether vaccination against a common virus found in almost all people with multiple sclerosis (MS) could help treat the condition.
The early-stage Phase 2 trial will initially evaluate the safety of the investigational vaccine, which aims to support the body’s immune response to the Epstein-Barr virus (EBV), while also examining its potential effect on new MS disease activity.
The investigational vaccine will be trialled in patients recently diagnosed with MS who have EBV, with 180 individuals to be recruited globally. The Horizon trial will involve up to ten sites across the UK, led by the University of Edinburgh, and is sponsored by pharmaceutical company Moderna.
The UK has some of the highest rates of MS in the world. The condition develops when the immune system, which usually protects the body by fighting off infection, attacks the brain and spinal cord. EBV infects more than 90 per cent of people in the UK. It usually causes no symptoms but can lead to glandular fever. Once infected, the virus remains hidden in the body for life but can become active again.
The investigational vaccine aims to help train the immune system to keep the hidden virus suppressed, which is thought to be a potential underlying cause of MS. Scientists are investigating whether population-wide vaccination against EBV might one day play a role in MS prevention, but experts caution this approach is at an early stage of testing and further research is required.
This is an important and innovative trial to treat multiple sclerosis by targeting EBV infection using a vaccine. Currently, almost all of our disease-modifying treatments for multiple sclerosis work by suppressing the body’s immune system. The discovery that EBV plays an important role in the development of multiple sclerosis is opening new avenues for treating the condition.
Group Leader
Prof Dame Anne Dominiczak, Chief Scientist (Health), Scottish Government said:
“The partnership between the University of Edinburgh, the National Institute of Health and Care Research and NHS Research Scotland has enabled the UK to be the first country outside the US to open the study, affording more UK patients the choice to participate in the trial. That is a vital step which could potentially lead to a significant breakthrough underpinned by Scottish leadership.”
Dr Maria Koufali, Life Sciences Director, National Institute of Health and Care Research said:
“By being first in Europe to open and recruit to Horizon, the UK has again demonstrated its ability to deliver fast, complex, trial set-up and to support world-leading science in partnership with industry. This is vital for attracting cutting-edge research, driving innovation, and improving health outcomes in the UK for all."
Sarah Collins, Director of Commercial, Vaccines & Countermeasures Delivery at UK Health Security Agency said:
“This new Horizon Trial, targeting the Epstein-Barr virus, exemplifies the groundbreaking work being undertaken as part of the Government’s strategic partnership with Moderna, led by the UK Health Security Agency. Not only does this Partnership provide additional resilience to respond more effectively to any future pandemic, but also opens doors to working closely with academia to develop new vaccine products for a range of existing health conditions. If successful, these would help support the Government in its delivery of the 10 Year Health Plan and the focus on prevention.”
People taking part in the Horizon trial must be 18 to 55 years of age and have been diagnosed with MS in the past two years. Participants will receive either the investigational vaccine or a placebo jab. The trial will last for approximately two and a half years and participants must be willing to have at least 14 scheduled clinic visits and 21 phone calls with the clinical trial team over that time.
More information is available from the NIHR Be Part of Research website: https://bepartofresearch.nihr.ac.uk/join.
The Horizon trial is being undertaken as part of the Moderna-UK Government Strategic Partnership, coordinated by the UK Health Security Agency. Set up and delivery of the trial is being supported by the UK Vaccine Innovation Pathway, NHS Research Scotland and the National Institute of Health and Care Research, who are working together to accelerate vaccine trials in the UK.
Source: University of Edinburgh