The 6 in 1 Part 2 Vaccine Study
Who can be involved? The Adam Practice is inviting healthy children who have not yet had their 12-month immunisations to take part in the study.
What is the study about? One of the vaccines currently given at the age 12 months in the UK routine immunisation programme is due to be withdrawn in 2025. The routine schedule will therefore be revised. Various options have been considered. This study is to assess a possible new immunisation schedule before it is made routinely available.
In particular, the study will investigate the “6-in-1” vaccine (which protects against diphtheria, tetanus, poliovirus, whooping cough, hepatitis B and Haemophilus influenzae type b). There are two licenced 6-in-1 vaccines available, Infanrix hexa and Vaxelis. The components of these two vaccines are not quite identical. At present, the same vaccine (either Infanrix hexa or Vaxelis) is recommended to be used for each of the three doses in the initial course (given at ages 2, 3 and 4 months). It is hoped that giving booster doses at 18 months of age will increase the protection against these diseases. If a booster dose is introduced, it will be useful to know whether the two vaccines can be used interchangeably. Our study will investigate this question. If either vaccine can be used as a booster, it makes delivery of the vaccine programme easier and more flexible; it also ensures that if one of the vaccines becomes unavailable, the other can be used instead.
What happens in the study? Participants in the study will be given their routine 12-month vaccinations (apart from Hib/MenC, which the Joint Committee on Vaccination and Immunisation has advised is no longer necessary at this age because of good herd immunity in the UK). At 18 months of age, they will be given 6-in-1 vaccine and MMR vaccine. Participants will also have the option of receiving two doses of a varicella vaccine. Varicella is the virus which causes chickenpox. It is possible varicella vaccination will be added to the routine childhood schedule in future. If your child takes part, after the 18-month vaccinations you will be asked to record symptoms in a diary every day for 7 days, and to record your child’s temperature for three weeks. Participants will have two blood test during the study to assess their immune response.
What can I do if I’m interested in taking part? If you would like further information about the study, please contact the study team:
01202 339050
https://trials.ovg.ox.ac.uk/trials/6-1-part-2-vaccine-study-adam-practice
Recruitment – Open to recruitment
Lead Research staff contact for this study
Wendy Higson
Sally Bradfield
Sarah Orr
Principle Investigator for this study
Dr Patrick Moore
COAT Study
This study is funded by the National Institute for Health Research. This is the main government funder for health studies in the NHS. The study is being sponsored by the University of Southampton and is being coordinated by the Southampton Clinical Trials Unit. Patients from The Adam Practice can take part, though there is no obligation to do so. Participation is entirely voluntary.
The study aims to compare a 5 day versus a 7 day course of an antibiotic called Flucloxacillin in patients with a diagnosis of cellulitis.
Cellulitis is a deep skin infection. Most people with cellulitis in the U.K. are treated with the antibiotic flucloxacillin for 7 days. However, research studies show that short courses of antibiotics (5 days or less) work as well as longer courses for many different types of infections, including serious infections like pneumonia. For cellulitis, there have been some studies that have shown that short courses work as well as longer course, and U.K. guidance recommends a 5 – 7 day course. However, there have not been any studies comparing short and longer courses of flucloxacillin prescribed outside of hospital settings (i.e. GP surgeries). Taking longer courses of antibiotics is likely to cause more side effects and kill off the ‘good bacteria’ that help keep us healthy.
Patients >18 years who have a diagnosis of cellulitis of one leg may be eligible to take part. Patients who have a penicillin allergy will not be suitable for the study.
Please link to the COAT study information site for full information.
Recruitment – Open to recruitment
Lead Research staff contact for this study
Rebecca Cutts
Wendy Higson
Tracey Dare
Helen Smith
Sally Bradfield
Sarah Orr
Brenda Furlong
Principle Investigator for this study
Dr Patrick Moore
Abbott - FreeDM2
Additional Information – http://www.freedm2.co.uk
Recruitment – Open to recruitment
Lead research staff contact for this study
Sally Bradfield
Sarah Orr
Principal Investigator
Dr Patrick Moore
ATHENA STUDY
ATHENA (Amitriptyline for the prevention of post-herpetic neuralgia) is a trial involving adults who are 50 years or older and have just been diagnosed with shingles. The study is funded by NIHR Health Technology Assessment and being led by a team at Bristol University.
Shingles can cause nerve pain in the area of the shingles rash, months after the rash has gone. This is called “post-herpetic neuralgia”. Currently there are no treatments to prevent this, but it is thought that a drug called amitriptyline may help and this trial will help to determine if this is the case.
Eligible participants will be asked to take tablets for 10 weeks and will be followed up for a 12-month period. They will be asked to complete seven questionnaires, each 5-10 minutes long. As this is a clinical trial the participants will not know whether they are taking the trial medication or a placebo “dummy tablet”.
Further information can be found by following the link below. If you have just been diagnosed with shingles and are interested in the trial, please inform your GP and/ or contact the research team.
Recruitment – Open to recruitment
Lead research staff contact for this study
Sally Bradfield
Wendy Higson,
Rebecca Cutts
Tracey Dare
Principal Investigator
Dr Sarah Lumley
Sub Investigators
Dr Ben Oxley
Dr Patrick Moore
Dr Charlie Powell
| Additional Information – https://athena-study.bristol.ac.uk/about-the-study/ If you would like to know more please contact us by telephone or e mail: Research Team Voicemail 01202 339050 [email protected] . |
NUTRICIA
The aim of this study is to understand more about formula fed children with cow’s milk protein allergy, and to learn how the use of a hypoallergenic formula containing prebiotics and probiotics impacts upon the experiences of children and their parents/carers.
Cow’s milk allergy is an immune reaction to the protein found in cow’s milk and affects up to 40000 babies annually in the UK. It can cause symptoms such as diarrhoea, vomiting, eczema, urticaria and wheezing, and can be managed by mothers avoiding dairy products if breastfeeding or using an extensively hydrolysed or amino acid-based milk formula if bottle feeding. Research studies have shown that having “good bacteria” in the gut results in better health outcomes for formula fed infants, and higher levels of good bacteria have been shown to reduce incidences of infection and to prevent the development of other allergies. Infants with cow’s milk allergy often have lower levels of good bacteria in the gut and are likely to benefit from a formula containing prebiotics and probiotics to increase the number of good bacteria.
Nutricia Ltd have produced two hypoallergenic milk formula products for the dietary management of cow’s milk allergy; Aptamil Pepti Syneo which is an extensively hydrolysed formula, and Neocate Syneo which is an amino acid-based formula. The health outcomes, healthcare use and allergy-related symptoms of infants using these milk formula products will be observed, and this study will seek to understand the experiences of using these products for both infants and parents/carers.
Recruitment – September 2021-September 2023, data collection until September 2024.
Lead research staff contact for this study – Rebecca Cutts
Additional Information
- What should I do if I think my baby is allergic or intolerant to cows’ milk? – NHS (www.nhs.uk)
- https://www.nutricia.co.uk/hcp/pim-products/aptamil-pepti-syneo.html
- https://www.nutricia.co.uk/hcp/pim-products/neocate-syneo.html
VENUS
This study is being carried out by to investigate and compare the use of different compression therapy in treating venous leg ulcers.
Venous leg ulcers are common a common problem and can often be recurring, presenting as open wounds on the lower leg. Compression is the first line of treatment for venous leg ulcers. A range of compression therapies such as four-layer bandages, two- layer hosiery, two-layer bandages and compression wraps are regularly used in the NHS.
- 1. Compression wraps (adjustable hook-and-loop-fastened compression): A compression sleeve around the foot and leg
- 2. Four-layer bandage or two-layer compression hosiery: If you are allocated to this treatment group, you and your healthcare professional will decide which treatment you receive. This will be either four layers of compression bandages or two layers of compression stockings
- 3. Two-layer compression bandage: this bandage will comprise of an initial bandage layer with a top compression bandage
We are conducting this study because we are unsure whether one compression therapy is more effective at treating venous leg ulcers than the others. To find the answer to this question, VenUS 6 will recruit and gather important information from a large number of people with a venous leg ulcer(s).
Recruitment – Currently open to recruitment.
Lead research staff contact for this study – Wendy Higson & Brenda Furlong
Additional Information
- https://www.nhs.uk/conditions/leg-ulcer
- https://legsmatter.org/help-information/resources-for-healthcare-professionals/guide-for-leg-ulcer-compression-therapy
- https://bnf.nice.org.uk/wound-management/compression-hosiery-and-garments.html
ZEUS
This study is a multinational study by the pharmaceutical company Novo Nordisk, planned recruitment worldwide is 6200, we are looking for about 12 participants. The study drug is called Ziltevekimab, this is an antibody that targets and neutralises inflammation. It is known that inflammation leads to a build-up of fat in the blood vessels. The study is to test if Ziltivekimab can reduce the risk of future cardiovascular events.
The target population is those participants that are high risk of having further cardiovascular events, we are looking for participants with evidence of atherosclerotic cardio vascular disease within the last 5 years. Examples are:
- Myocardial infarction
- Stenosis of major coronary artery
- Stroke of atherosclerotic origin
- Peripheral arterial disease
- Intermittent claudication
- Lower amputation due to atherosclerotic disease
The study can last for up to 4 years.
Recruitment – Open to recruitment
Lead research staff contact for this study – Sally Bradfield, Tracey Dare & Rebecca Cutts
GMRx2
This trial is being conducted by Imperial College, London and George Medicines and will be evaluating a new medicine called GMRx2 (a single pill which contains active ingredients from three different blood pressure-lowering medications).
High blood pressure is a leading cause of cardiovascular disease – which includes heart attack and stroke. Therefore, managing high blood pressure is important for the prevention of cardiovascular disease. Most people with high blood pressure do not achieve adequate blood pressure control with just one medication. Some research suggests that low doses of three medications may be effective at controlling high blood pressure without increasing side-effects, and use of a single pill can simplify therapy.
The new single pill medicine called GMRx2, contains active ingredients from three different blood pressure-lowering medications called telmisartan, amlodipine and indapamide. All three of these medications have been given to large numbers of people over the last few decades and are already prescribed in many countries. These medications are used either on their own or in combination with other blood pressure-lowering medications. In this trial GMRx2 will be tested in two different dose versions.
The purpose of this trial is to find out if the GMRx2 triple combination medication is equally or more effective and as safe in lowering high blood pressure compared with any combination of 2 of the active ingredients.
Recruitment – CLOSED to recruitment
This trial will be conducted in approximately 1500 participants in several countries including USA, Australia, New Zealand, Sri Lanka, Poland, Czech Republic, South Korea and the United Kingdom.
Lead research staff contacts for this study
Tracey Dare, Becks Cutts, Sally Bradfield & Brenda Furlong
Principle Investigator/ Sub Principle Investigator for this study
Dr Benjamin Oxley, Dr Patrick Moore, Dr Sarah Lumley & Dr Charlie Powell
Additional information
ATTACK
This study is being carried out by The British heart Foundation and the National Institute for Health Research (NIHR) to test the hypothesis that the addition of 75mg aspirin once daily to usual care reduces the risk of major vascular events in patients with chronic kidney disease (CKD) who do not have pre-existing cardiovascular disease (CVD) .
CKD is common, particularly in older people and ranges from mild, moderate to severe. People who have mild to moderate disease may not even be aware as it doesn’t cause any outward symptoms. However, having CKD is significant because we know that it will increase the risk of developing cardiovascular disease leading to events like heart attacks and strokes later in life.
At present, people who have CKD and who have established cardiovascular disease and have already had a heart attack or stroke, will be prescribed aspirin to help prevent a further episode (this is called “secondary prevention”). However, we don’t yet have evidence to prove that if you have CKD and have not had a heart attack or stroke, that taking aspirin as a preventative measure (this is called “primary prevention”) can offset this risk.
This study will look at whether the taking 75mg aspirin daily (in addition to usual care) reduces risk of major vascular events in people with CKD who do not have pre-existing CVD, and whether and to what extent the benefits outweigh any harms due to increased risk of bleeding.
A positive result from ATTACK will help prevent around 50,000 major vascular events (i.e heart attack or stroke) across the UK over a 5-year period. However, a negative trial result provides definitive evidence to stop aspirin in 1 million people currently taking it for primary prevention of CVD.
Recruitment – 25,000 people will be recruited into this study across the UK. Half of the participants in the trial will be randomised to a daily prescription of Aspirin 75mg daily and half will be randomised to usual care (no aspirin).
Recruitment – CLOSED to recruitment.
Lead research staff contact for this study – Tracey Dare
Principle Investigator for this study – Dr Benjamin Oxley
Additional Information
https://www.southampton.ac.uk/attack-trial/information-for-patients.page
Trimaximise
This is an observational study for patients over the age of 18years, with a confirmed diagnosis of asthma and who are prescribed an inhaler called “Trimbow”.
Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium),a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone). Trimbow MS (medium strength) contains 100 μg beclomethasone whereas Trimbow HS (high strength) contains 200 μg beclometasone. Both formulations are investigated in this study.
Trimbow has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow on changes in patients’ symptom burden and quality of life, adherence and clinical outcomes have not been assessed yet in a real-world asthma patient population.
This non-interventional study aims to collect prospective, longitudinal data from asthma patients under routine care, for whom the treating physician has decided to prescribe Trimbow MS (medium strength) or Trimbow HS (high strength) as per its current authorised indication. Aspects of adherence to Trimbow will be collected to gather knowledge on whether a single-inhaler triple therapy will lead to greater adherence and better clinical outcomes.
The study will collect data every 3 months. Total study participation will be 1 year.
Recruitment – Closed to Recruitment
Planned recruitment 3950 patients Europe wide.
200 patients from the UK.
Lead research staff contacts for this study– Rebecca Cutts and Brenda Furlong
Principle Investigator for this study– Dr Patrick Moore and Dr Benjamin Oxley
Additional information links/ hyperlinks
https://clinicaltrials.gov/ct2/show/NCT04902573
VESALIUS-CV
This study is being carried out by a commercial company called Amgen to investigate and compare the use of a monoclonial antibody injection called Repatha versus placebo.
The purpose of this study is to evaluate a cholesterol medication called “evolocumab” (“Repatha”) in reducing risk for major cardiovascular events (for example, heart attack or stroke). A lot of people already take cholesterol lowering medication called a statin but sometimes, despite this, the cholesterol in the blood stream remains high and this increases risk of cardiovascular events later in life.
Repatha works in a different way to statins. Statins help stop your liver from making as much cholesterol. Repathahelps the liver to clear bad cholesterol by limiting the actions of a protein called PCSK9, which means less bad cholesterol in your blood stream. If enrolling for the study, you would still need to take to statins. The study is “blinded” which means you would not know if you were prescribed the Repatha or a placebo.
A total of about 12,000 people are expected to participate in this study, out of which, approximately 1,200 participants will be enrolled from the UK. This study will take place in approximately 900 centres globally.
Recruitment – Closed to recruitment as of Dec 2021
Lead research staff contact for this study – Tracey Dare
Principle Investigator/ Sub Principle Investigator for this study – Dr Patrick Moore & Dr Benjamin Oxley
Additional Information
- https://www.clinicaltrials.gov/ct2/show/NCT03872401
- https://www.amgen.com/newsroom/press-releases/2021/08/new-data-at-esc-congress-2021-shows-repatha-evolocumab-improves-features-of-plaque-stability-in-patients-with-acute-coronary-syndrome-acs
Victor Study
Chronic Heart Failure (CHF) is a condition where the pumping ability of the heart is impaired. There can be may different causes of heart muscle weakening and symptoms can include breathlessness, fatigue and fluid retention. We already know that this can be managed effectively with different types of medications that prevent further weakening and strain on the heart (for example angiotensin converting enzyme inhibitors (“ACE” inhibitors), Beta blockers to name a few).
This trial is studying an investigational drug (MK-1242, also called vericiguat) to see if it can treat a type of heart failure where the heart has less strength than normal to pump blood to the body. You may be able to join this trial if you have chronic heart failure and have not had a recent worsening of your heart failure.
Vericiguat has been approved for treating some types of heart failure, but not for the type of heart failure that people in this trial have.
This trial is being done to:
• Test the safety and tolerability of vericiguat compared to placebo
• See if taking vericiguat lowers the chances of being hospitalised with worsening heart failure compared to placebo when added to your existing heart failure treatment
• See if vericiguat lowers the chances of dying from cardiovascular causes (heart and blood vessel) compared to placebo when added to your existing heart failure treatment
People in this trial will be randomly assigned (like flipping a coin) to take vericiguat or a placebo. A placebo is a look-alike pill that contains no real, active medicine. You will also continue to take your current medicines for heart failure during the trial.
The investigational drug is a tablet taken by mouth once a day.
While voluntary, if you join, you will be in this trial for about 2 years.
You will be able to stay on your current heart failure medications during the trial.
You can change your mind and stop taking part in the trial for any reason at any time. There is no cost to be in this trial and reasonable travel expenses will be reimbursed.
Recruitment – Closed to recruitment
The trial is recruiting from around the world in 34 countries and aiming to recruit around 6000 patients.
Lead research staff contact for this study
Tracey Dare
Helen Smith
Sally Bradfield
Principal Investigator
Dr Patrick Moore
Additional Information/ Hyperlinks https://www.merck.com/news/merck-announces-initiation-of-phase-3-study-evaluating-verquvo-vericiguat-in-patients-with-chronic-heart-failure-and-reduced-ejection-fraction-who-have-not-had-a-recent-worsening-heart-failure/
If you would like to know more please contact us by telephone or e mail: Research Team Voicemail 01202 339050 [email protected]
Additional Information