We are looking for participants for the Nova 301 Trial. This trial will see if an investigational vaccine can protect people 60 years of age or older against symptoms caused by the norovirus stomach bug.
Norovirus is one of the most common stomach bugs in the UK. It can spread easily and most cases are often in care homes and schools. The norovirus stomach bug can cause many unpleasant symptoms like nausea, vomiting, and diarrhoea. Vulnerable people, such as children younger than age 5, adults older than age 60, and people with underlying health conditions, are at greater risk for serious symptoms of norovirus, which may require medical attention.
About the Nova 301 Trial
The Nova 301 Trial will see if an investigational vaccine (a vaccine that is being studied) may be able to prevent symptoms caused by the norovirus stomach bug from developing in people 60 years of age or older. The investigational vaccine in this clinical trial is called mRNA-1403. You cannot catch norovirus by having this investigational vaccine.
Who can join?
This clinical trial is looking for participants. To join, you must:
be 60 years of age or older
be in good health
not currently have a chronic gastrointestinal disease (including irritable bowel syndrome, colitis, oesophageal reflux, or any other medical condition where you have regular vomiting or diarrhoea)
What to expect
Your participation in the Nova 301 Trial will last up to 25 months.
You will attend an initial screening visit, up to 6 additional clinic visits and up to 6 scheduled phone calls with the clinical trial team
You will be given 1 jab, which will be either:
An investigational mRNA-1403 norovirus vaccine; OR
A placebo jab (inactive substance)
You must fill out an electronic diary (eDiary) regularly during your trial participation
Enrolling in this clinical trial is completely your choice. You can leave at any time and do not have to give a reason
Moderna will reimburse participants for their trial-related time and expenses (for example, travel), and the clinical trial team are on hand to support everyone who takes part in the trial.
Contact the clinical trial team today
Contact the research team to find out more about joining the Nova 301 Trial.
Patients who wear facial prostheses after treatment for head and neck cancer have had their portraits painted to illustrate the physical and psychological impact of living with a facial difference.
Fifteen patients, who wear facial prostheses – bespoke removable silicone devices that replace a facial part such as an eye or nose – took part in the Leeds CRF IMPRESSeD study, comparing modern and conventional methods of producing the prostheses in an early look at which technique was preferred by patients and potentially more cost-effective. The study was funded by the National Institute for Health and Care Research (NIHR) and Leeds Hospitals Charity.
The portraits were painted as part of a public engagement project, named “I’m Still Me”, which was inspired by the research and co-created by the patients, researchers, healthcare professionals, artists, and public engagement practitioners. They will be exhibited in the Atrium of the Bexley Wing at St James Hospital, Leeds, from 6 November 2024 to 31 January 2025. The public engagement project was funded by Research England’s Enhancing Research Culture funding stream with additional support provided by a University of Leeds Engagement Fellowship.
The IMPRESSeD study was led by Dr Rachael Jablonski, current NIHR Academic Clinical Lecturer and Specialty Registrar in Restorative Dentistry at the Leeds School of Dentistry and Leeds Dental Institute, as part of her PhD.
Dr Rachael Jablonski
She said: “Head and neck cancer can have a major impact on a patient’s health and wellbeing and receiving a prosthesis can be an important part of the process of coming to terms with the experience.
“I worked with patient and public involvement (PPI) contributors to identify areas for improvement in the processes of making prostheses. Fifteen patients took part in the feasibility trial and were invited to take part in an interview after they had gone through both conventional and new methods. Almost all the patients who took part in the interviews preferred the newer processes of making facial prostheses in our initial study. The next step would be a future full-scale trial.”
The conventional prosthesis manufacturing process involves multiple clinical and laboratory procedures over several hospital visits with highly trained Maxillofacial Prosthetists, who recreate the facial part.
Firstly, an impression of the patient’s face is taken using a silicone or alginate material, which can be claustrophobic or uncomfortable, and may distort the facial tissues, affecting the final product.
Maxillofacial Prosthetists use the impression to pour a plaster model, hand-sculpt a wax pattern, then convert it into a silicone prosthesis. Replacements are needed every two years, but sometimes as often as soon as six months, due to changes in the patient’s face during the healing process; prosthesis wear and tear, and general degradation. Estimates suggest that the process can take up to 10 hours to complete and cost up to £1,500.
New facial prosthesis manufacturing techniques employ 3D facial scanning as a less invasive way of capturing the shape and texture of a patient’s face, as well as computer-aided design using artificial intelligence to reconstruct the facial feature, and 3D printing the design to help produce the facial prosthesis.
Digital technologies have the potential to support or replace steps in the manufacturing processes potentially helping to address pressures on the small numbers of qualified Maxillofacial Prosthetists working in the NHS.
Dr Jablonski worked with patients to identify priority areas for improvement in the manufacturing process, which were getting rid of uncomfortable facial impressions; more closely matching the way their face looked before surgery, and receiving their prosthesis sooner after surgery.
Patients from Leeds Teaching Hospitals NHS Trust and Guy’s and St Thomas’ NHS Foundation Trust in London received facial prostheses made using conventional and digital manufacturing approaches and were asked to assess both methods towards the end of the study.
Dr Jablonski said: “We found that 90% of patients we interviewed preferred digital over conventional processes due to the comfort, speed, hygiene, and perceived positive impact on outcomes associated with digital technology. Some patients felt contactless scanning may offer benefits when a patient’s skin is sore after surgery or radiotherapy, and others considered the computer aided design technology and 3D printing to be sophisticated and a positive step forward.
“However, the patients were also keen to ensure they would not lose out on the skilled finishing touches from the conventional approach.”
I’m Still Me was created as a collaborative arts-science project to share the lived experience of people who wear facial prostheses, bring the research findings out into the wider community, and highlight the valuable role of patients in research and public engagement.
The portraits were created by a group of painters assembled by Salford artist Sarah Morley following her work on a similar, previous project. Together with writers and researchers, the artists worked with the patients to co-design the I’m Still Me exhibition. The portraits are each displayed alongside a narrative describing the patient’s rehabilitation with facial prostheses, to raise awareness of the innovative science, and to raise public awareness about face equality.
Dr Jablonski said: “Research is typically not very accessible to the general public. We knew that when we shared the research, we wanted to make the findings as accessible as possible. There has also traditionally been an underrepresentation of people with visible differences in public life and the media. It was therefore important that the project not only shared our research findings but also communicated key issues that were most important to the patient contributors.
“We hope that I’m Still Me shares messages of face equality and stimulates a reflection on how people should be valued through their own unique stories and contributions.”
Patients’ quotes
Suzie “This is what I am, and this is what I look like.” “Stick with it. Things get better.”
Robin “Cancer has many faces – this is mine.” “Prostheses act as a shield for the public who might be upset if they found out what we really looked like – they provide a level of public acceptability.”
Tim “Wearing my eye patch I get comments, especially from children, like, “Where’s your parrot? “Don’t look back. Look forward and grab life. Whether it’s long or short, grab your life and run with it.”
Rebecca “A prosthetic arm or leg would be functional, but I can’t see out of my prosthetic eye.” “Who is the prosthesis for? Me or the public?”
Peter “We have the results of our cancer surgery visibly on show; it can’t be hidden away.” “All I wanted was a nose the right shape so I could put my glasses on.”
Derek “Being involved in research has been no hardship. I would encourage others to get involved.” “While the processes can take some time, having a prosthesis has been life changing.”
David “I like to get involved with research to try and prevent what happened to me from happening to other people” “I get stressed when people stare at me.”
Chris “It’s my face, what’s it got to do with you?” “I had no option but to wear it. You can’t hide away, and you can’t go around with a big hole in your face, or you’d scare people.”
The NIHR Leeds Clinical Research Facility at Leeds Teaching Hospitals NHS Trust (LTHT) has made a significant stride in the fight against melanoma by recruiting our first patient for an international clinical trial testing a ground-breaking cancer immunotherapy vaccine. LTHT is one of eight sites in the UK exploring a personalised mRNA vaccine designed to prevent recurrence of the most serious form of skin cancer, melanoma.
Matthew Adams, a family man from Apperley Bridge in Bradford, is the first of our patients to be recruited to this trial. An engineering manager for Yorkshire Water, Matt lives with his wife of 36 years, Linda, and their two daughters. Recently, the arrival of his new grandson brought joy into his life, making his health battle even more personal.
In February, Matt was diagnosed with melanoma, and he was admitted to the hospital for treatment in April. “I had the primary “mole” removed, followed by a biopsy of the swollen lymph nodes,” Matt recounts. “I must give special thanks to James Smith, my plastic surgeon, who did an amazing job. He was the first person who fully explained all my options and possible treatments, including the chance of a vaccine trial. His positivity is one of the main reasons I considered it.”
James Smith’s explanation of the vaccine attracted Matt’s interest. However, his oncologist Dr Maria Marples’ support made his decision clear. “Maria is so lovely and kind,” Matt shares. She went through the risks and benefits many times, making me feel comfortable with my choice to take part in the trial.”
After receiving the vaccine, Matt did not experience any physical pain, and he credits the research nurses at LTHT for his care. “The research team at St James’s is amazing,” he says. “They made me feel at ease right from the start. A special mention to Willombe, my research nurse, who has had to put up with me from the start. She has been under a lot of pressure setting up the trial and taking endless amounts of blood.”
Matt encourages other cancer patients to consider participating in clinical trials. “The team at St James’s explains everything from start to finish in a way you can understand,” he emphasises. “Yes, absolutely, I would recommend it.”
The personalised mRNA melanoma vaccine, being developed by Moderna and Merck Sharp and Dohme (MSD), is designed to match the unique genetic signature of each patient’s tumour. The vaccine instructs the body to produce proteins, or antibodies, that target markers found on that patients’ cancer cells. In this trial, the vaccine is combined with the standard-of-care immunotherapy drug, pembrolizumab.
This vaccine technology builds on that used to develop many COVID-19 vaccines and is currently being tested in other clinical trials in a range of cancers. As yet, these vaccines are not approved as safe and effective, so they are not available outside clinical trials. They may, however, represent the next frontier in cancer treatment.
Consultant Oncologist Dr Jane Hook, the Principal Investigator of the trial at LTHT, said. “This clinical trial is using cutting-edge science to personalise cancer treatment and we hope it will increase the chance of cure for people with melanoma. We are excited to be taking part in this important study and grateful to our patients who agreed to participate in the trial.”
UK Lead Investigator Dr Heather Shaw added, “This vaccine has the potential to be a ‘game-changer,’ improving the chance of a cure for people with melanoma and potentially other cancers such as lung, bladder, and kidney tumors.”
The vaccine was administered by Team One Oncology research team. Well done to the team for their efforts.
Melanoma, the most severe form of skin cancer, is marked by the uncontrolled growth of pigment-producing cells. Rising steadily over the past decades, melanoma saw nearly 325,000 new cases diagnosed worldwide in 2020. In the UK, it is the fifth most common type of cancer, with about 8,400 new cases annually.
– A mole that has changed size, shape, or color
– A mole that is painful or itchy
– A mole that is inflamed, bleeding, or crusty
– A new or unusual mark on the skin that persists after a few weeks
– A dark area under a nail not caused by an injury
