NIHR Southampton Biomedical Research Centre cancer researchers have joined experts across the country in a new collaboration to more rapidly turn scientific discoveries into real patient benefits. The National Institute for Health Research (NIHR) Oncology Translational Research Collaboration (TRC) brings together the country’s leading cancer researchers from across NIHR Biomedical Research Centres. They will collaborate on studies driving advances in key areas including early diagnosis, surgery, immunotherapy and radiotherapy. Working together Chaired by the NIHR Biomedical Research Centre (BRC) at The Royal Marsden and The Institute of Cancer Research, London – the UK's only NIHR BRC dedicated solely to cancer, the Oncology TRC aims to do research that would be impossible for individual centres by combining expertise and resources. In Southampton, Professor Mike Grocott and Dr Matthew Wheater will oversee our NIHR BRC’s role in the collaboration, and the studies it conducts will complement research undertaken by other cancer research networks. Improving cancer treatment By working together, the Oncology TRC will share expertise and best practice, spot gaps in research and areas of unmet need, and identify opportunities to work with external partners, including industry and charities. Professor Stan Kaye, Consultant Medical Oncologist at The Royal Marsden and Chair of the collaboration, said: “Progress in cancer research demands collaboration and I am delighted the NIHR's leading Biomedical Research Centres will unite through the Oncology TRC. Our programme of work is just beginning, and I am confident that it has the potential to make a significant contribution to improving cancer treatment and care in the next few years.” To find out more about the O-TRC, visit its page on the NIHR website or contact nocri@nihr.ac.uk.

The country’s largest clinical study investigating the best gap between first and second COVID-19 vaccine doses for pregnant women is launching in Southampton. The Preg-CoV study, which will take place in the NIHR Southampton Clinical Research Facility (CRF) at University Hospital Southampton NHS Foundation Trust, will begin recruiting participants later this month. Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton, will be the local investigator for the trial. Finding the best dosage interval Led by St George’s, University of London, and backed by £7.5 million of government funding, the study will provide vital clinical trial data on the immune response to vaccination at different dose intervals. This will help determine the best dosage interval and tell us more about how the vaccine works to protect pregnant mothers and their babies against COVID-19. Participants will receive two doses of either the Pfizer/BioNTech or the Moderna vaccines (or one dose if they’ve already had their first), at either the shorter interval of four to six weeks, or the longer interval of eight to 12 weeks. More than 600 pregnant women will take part in the study across 13 NIHR-supported sites. Participants will need to be between 18 and 44-years-old, generally healthy and between 13 and 34 weeks pregnant on the day of vaccination. Participants will be closely monitored by health professionals throughout their pregnancy and following the birth, with the safety of the women taking part in the study the utmost priority. They will be scheduled to attend nine visits in total and will be required to complete an electronic diary between visits on any symptoms. They will also be given a 24-hour mobile number so they can contact one of the trial team at any time if they have concerns. "While we have a large amount of real-world data which tells us that it's safe for pregnant women to receive approved COVID-19 vaccines, the data gathered from a clinical trial like this will give us additional information about how these approved vaccines can be used in pregnancy to ensure optimal protection for the mother and baby,” said Dr Chrissie Jones. “All women taking part in the study will receive the approved Pfizer/BioNTech or Moderna vaccines, as well as additional monitoring and support from their local research team." Providing more data on COVID-19 vaccination in pregnancy Pregnant women are more likely to develop severe COVID-19 or die from the disease, but are excluded from clinical trials with new vaccines. This means there is currently very limited clinical trial data on the immune response and side effects caused by the vaccines for these women. Following 130,000 pregnant women being vaccinated in the US and no safety concerns being raised, the Pfizer/BioNTech and Moderna vaccines were recommended by the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) for pregnant women in the UK. Over 52,000 pregnant women in England have now been vaccinated - similarly, with no safety concerns. Recent data published last week by NHS England and the University of Oxford shows no pregnant women who have had both doses of a vaccine have been admitted to hospital with COVID-19. Only three have been admitted after having their first dose, meaning 99% of those admitted to hospital have not received a jab. The scientists behind the trial will analyse blood samples from the participants and one blood sample from their newborn babies, alongside samples from breastmilk. They will use the samples to help understand more about how the vaccines are protecting both pregnant women and potentially also their babies from COVID-19, with initial results expected by the end of the year. “Current experience strongly suggests that COVID-19 vaccination in pregnancy is the safest choice in reducing the risk of occasionally serious COVID-19 illness for mothers and early birth for babies. However, more research is required to understand how COVID-19 vaccination achieves this, including the best timing for vaccination,” commented Dr Matthew Coleman, Consultant Obstetric Physician at University Hospital Southampton. “Pregnant women, especially later in pregnancy, seem to be at additional risk from more serious COVID-19 illness, so this study is important for women as individuals and for the wider community, including other pregnant women and their families.” Taking part Those interested in finding out more and taking part can visit the Prev-Cov study website. Participants will also be recruited to the study by invites sent through the NHS COVID-19 Vaccine Research Registry, which allows research teams to speak to suitable volunteers who have signed up to be contacted about taking part in vaccine studies. “Pregnant women are more likely to get seriously ill from COVID-19 and we know that vaccines are safe for them and make a huge difference – in fact no pregnant woman with two jabs has required hospitalisation with COVID-19,” said Minister for COVID-19 Vaccine Deployment Nadhim Zahawi. “This government-backed trial will provide more data about how we can best protect pregnant women and their babies, and we can use this evidence to inform future vaccination programmes. I encourage anyone who is pregnant and eligible to sign-up and contribute to research that will save lives for years to come.”

Pregnant women in Southampton are being invited to take part in a COVID-19 vaccine study. Preg-CoV is the UK’s largest clinical study to investigate the best gap between vaccine doses for pregnant women. The results will help shape national and international guidance around COVID-19 vaccination and pregnancy. Recent data shows that one in five of the most critically ill COVID-19 patients are pregnant women who have not been vaccinated. Over 84,600 pregnant women have received the first dose of the COVID-19 jab, and around 80,700 have received their second dose. Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton and local investigator for the study, said: “We are inviting women who are pregnant and have not yet had any COVID-19 vaccines, as well as those that have already had one or two doses of a COVID-19 vaccine, to take part in the Preg-CoV study. “We now have lots of ‘real-world’ data to show that these vaccines are safe and effective, now we are investigating the best timing of COVID-19 vaccines in pregnancy to ensure that women have the best protection from these vaccines for themselves and their babies.” Identifying the best dosage interval The research will compare vaccines that are currently being used for the UK vaccination programme (Pfizer/BioNTech and Moderna) as well as new vaccines as they are approved. It will provide vital clinical trial data on the immune response to vaccination at different dose intervals - either four to six weeks or eight to 10 weeks. This data will help determine the best dosage interval and tell us more about how the vaccine works to protect pregnant mothers and their babies against COVID-19. The Preg-CoV study will involve 600 pregnant women, across 14 NIHR-supported sites. Once successfully enrolled, most volunteers will be randomised to receive two doses of an approved COVID-19 vaccine with either a short-time interval (4-6 weeks) or a long-time interval (8-10 weeks) between doses, with the majority of volunteers blinded to which vaccine they receive. For some volunteers, this means they will receive their second dose after delivery. Participants will receive a single dose if they have already received their first dose or if they just need a booster (3rd) dose. The study is also recruiting participants who have already had two doses of a COVID-19 vaccine in the community. Volunteers needed in Southampton In Wessex, the study will take place in the NIHR Southampton Clinical Research Facility (CRF). Volunteers will need to be between 18 and 45-years-old, generally healthy and low-risk, carrying a single baby and between 13 and 34 weeks gestation. They will be closely monitored by health professionals throughout their pregnancy and following the birth, receiving additional support through study visits compared to those who receive their vaccine outside of the study. Volunteers will also be provided with a 24-hour phone line should they have any questions for the study team, and will be reimbursed for travel to their study appointments. Those interested in taking part can find out more by visiting the study website or contacting the local Southampton study team on UHS.RecruitmentCRF@nhs.net.

Pregnant women in the south are being invited to help discover the most effective use of booster vaccines during pregnancy. The Preg-CoV study, running at University Hospital Southampton NHS Foundation Trust, currently has around 300 pregnant women taking part nationally. It aims to determine the best vaccine schedules and doses to protect women and their babies against COVID-19. The study compares vaccines currently being used for the UK vaccination programme (Pfizer/BioNTech and Moderna) as well as new vaccines as they are approved for use, such as Novavax. The research is also assessing the immune response to different doses and intervals between vaccines during pregnancy. Participants may also be eligible to choose to receive their COVID-19 booster dose alongside the routine whooping cough vaccine. Protecting women and their babies The current UK guidance is that COVID-19 vaccination should be offered to pregnant women at the same time as the rest of the population. Dr Chrissie Jones, local investigator for the study, said: “COVID-19 vaccination in pregnancy has been shown to be safe in hundreds of thousands of women and to protect them against severe infection. Now we need to understand the very best ways to protect women and their infants with booster doses. This study will give us important information about the spacing of vaccines in pregnancy and whether a half dose of the booster is as good as the full dose of booster." Shaping future guidelines The study launched in August 2021, and will involve around 700 pregnant women in total, in sites across England. It is supported by the National Institute for Health and Care Research (NIHR). Pregnant women in the study will receive monitoring and additional support through study visits, compared to those who receive their vaccine outside of the study. They will also be provided a 24-hour phone line should they have any questions for the trial team and an electronic diary to record any symptoms. They will also be reimbursed for travel to their study appointments. Professor Paul Heath, Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s, University of London, said: “We are delighted that around 300 pregnant women have joined the study so far, but we need even more pregnant women across the country to participate. Not only will they receive special monitoring and support around their vaccines, but they will help shape future guidelines and protect pregnant women in the future. It is a really worthwhile, helpful thing to do.” Take part in the study The study is seeking low-risk, pregnant women who are carrying a single baby, are aged 18-45 years-old and are between 13-36 weeks gestation. The trial will collect blood samples from participants, with a cord blood sample taken after delivery for some participants. For all participants, a baby blood sample will be taken between 4 and 12 weeks of age. Breastmilk samples will also be collected for a sub-group of participants. Once enrolled, participants who have already received two or three doses of COVID-19 vaccine in the community will be eligible to receive a 3rd or 4th booster dose in the study. If they are also due their pertussis (whooping cough) vaccine booster they can have it at the same time, if they wish. All participants and their babies will be followed up until one year after delivery. If you are interested in the study, or know someone who could be eligible, you can find out more by visiting the study’s website.

The first COVID-19 vaccine study in the UK recruiting pregnant women has been launched across several National Institute of Health Research sites, including University Hospital Southampton. The phase 2/3 study aims to further understand the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in healthy pregnant women, with approximately 235 volunteers involved throughout the UK. Following updated guidance from the Joint Committee on Vaccination and Immunisation (JCVI) released in April, pregnant women are now offered approved COVID-19 vaccines at the same time as the rest of the UK population, based on their age and clinical risk group. Real-world data from the United States has been collected, in which over 100,000 pregnant women have been vaccinated (mainly with mRNA vaccines including Pfizer-BioNTech), without any safety concerns raised. The role of this placebo controlled study (COVID-19 Vacc Maternal Immunisation) is to provide more robust information on the vaccine immune response in pregnancy, as well as safety reporting and the potential transfer of maternal antibodies to infants. Each participant enrolled in the study will initially receive either two doses of the vaccine or a placebo 21 days apart. All participants will be unblinded one month post pregnancy, and those who were given the placebo jab (a salt water solution that does not contain any active ingredients) will receive the Pfizer-BioNTech COVID-19 vaccine. Recruitment will begin this week at the UK sites involved. The study has already been running in the US since February 2021. Research participants will be required to answer questionnaires about their health, provide blood samples, complete an e-diary and will receive extra monitoring while on the study, compared to those who receive a vaccine through the rollout. All volunteers will need to visit their site for four planned visits before their baby is born and then two more follow up appointments after the baby is born. Participants for the study will be identified via obstetricians and midwives at the hospital sites involved, with the study doctor determining whether each pregnant woman and their unborn baby would be suitable. Participation in the study is completely voluntary and participants can leave the study at any time. Dr Chrissie Jones, Associate Professor in Paediatric Infectious Diseases at University of Southampton, and Chief Investigator for the study said: "While we have a large amount of real-world data which tells us that it's safe for pregnant women to receive approved COVID-19 vaccines, the data gathered from a controlled research study like this is important because it will give us more information about the vaccine immune response in pregnant women, including the transfer of maternal antibodies to infants. “All women taking part in the study will receive two doses of the approved Pfizer-BioNTech vaccine, as well as additional monitoring and support from their local research team." For more information, please contact uhs.southamptoncrf@nhs.net or call 023 8120 4989.

Southampton researchers have been awarded £1.8m to run a new clinical trial to improve treatment for people with heart failure. The BRITISH trial aims to work out which patients could benefit from having an implantable cardioverter defibrillator (ICD) fitted under the skin in their chest. Consultant cardiologists Dr Andrew Flett and Professor Nick Curzen at University Hospital Southampton will lead the trial. Professor Curzen is also a researcher at the NIHR Southampton Biomedical Research Centre. Re-assessing who needs an implantable defibrillator Researchers in 35 UK hospitals will recruit over 2,500 patients. These patients will all have non-ischaemic cardiomyopathy (NICM) and evidence of scarring in the heart. They will be randomly allocated to have an implantable cardioverter defibrillator (ICD) or not. NICM is a common cause of heart failure, accounting for around a third of cases. Non-ischaemic refers to the fact that there is no narrowing of the coronary arteries (the most common cause of heart failure). Some patients with NICM can be at higher risk of sudden cardiac death due to dangerous, very fast heartbeats which can cause cardiac arrest. ICDs can treat cardiac arrest and stop abnormal heart rhythms by delivering an electric shock to the patient’s heart. Current guidelines look at how well the heart is pumping to decide which patients get an implant, but this may not be the best method. “These guidelines use an arbitrary cut-off of pump function,” says Dr Flett. “But a previous large trial has shown that most patients with NICM and an implantable defibrillator will never benefit from it. This also needs to be balanced against the risk of complications from an ICD. We want to find a better way to assess which patients will truly benefit from one of these devices before it is fitted.” “Evidence suggests that it is actually scar tissue within the heart that causes abnormal heart rhythms. We believe this could be a better measure of the risk of sudden cardiac death for a patient, and so will identify patients most likely to need an ICD.” Finding scarring in the heart The trial will recruit NICM patients where an MRI scan has detected the presence of scar tissue in the heart. They will then be randomly allocated to one of two groups, with half fitted with an ICD. They will use patient data to compare outcomes after three and five years in the two groups, to find out whether these patients need an ICD or not. If their results support it, all patients with NICM could have an MRI scan of their heart to look for scar tissue. If they do, they could be offered an ICD. The trial, sponsored by University Hospital Southampton, is due to open next year across the UK. It will be funded by the British Heart Foundation and co-ordinated by the NIHR Southampton Clinical Trials Unit. Dr Flett concludes, “If the BRITISH trial is successful, it could stimulate a change in international and UK guidelines for the treatment of NICM heart failure and implantable devices. We hope this would improve clinical outcomes for these patients in the future, and help reduce costs for our health service by ensuring only those who will benefit from ICDs have them fitted.”

Allergic reactions to peanuts are worse for adults if they’ve had a bad night’s sleep, research has found. The national study also explored whether exercise affected the severity of the reaction, but found no significant effect. Prof Graham Roberts from the NIHR Southampton Biomedical Research Centre supported the project as chair of the study steering committee. Findings are being used by the Food Standards Agency to assess what level of peanut is safe for people with allergies in the UK. The team’s results are published in The Journal of Allergy and Clinical Immunology. How does lifestyle affect allergies? Allergic reactions are known to vary depending on what the person has been doing before being exposed to the allergen. This introduces a level of uncertainty that makes allergies difficult to manage, both from the patient’s perspective and the doctor advising them. Yet there is little research showing what lifestyle factors have the strongest influence on allergic reactions, so patients and doctors don’t know what to look out for. In this study, the researchers investigated the effects of exercise and lack of sleep on peanut allergy. Three peanut ‘challenges’ Over 100 participants with a peanut allergy took part, including some with a severe peanut allergy. They were split into three groups. All groups were given a dose of peanut flour in a dessert three times - this is known as an allergy ‘challenge’. One time they were only allowed two hours of sleep the night before, another time they did intense exercise immediately afterwards, and another they did neither of these. The three groups did all of these, but each group did them in a different order. The researchers gave each allergic reaction a severity score, and found they were worse after the poor night’s sleep. They also found the severity increased as participants had more doses of peanut. How will these results be used? The UK Food Standards Agency (FSA) have to decide what is deemed a ‘safe’ level of peanut contamination for people with peanut allergy. They funded this study to help inform their decision making. Although sleep deprived people had a worse reaction, they only started to react at a very slightly lower level of peanut protein. This means the FSA does not need to lower their safe level any further to account for sleep deprivation. Prof Graham Roberts, Professor of Paediatric Allergy and Respiratory Medicine at the University of Southampton, said: “The minimal change in the amount of peanut protein causing an allergic reaction after being sleep deprived is reassuring for consumers with peanut allergy and the food industry. “It means that food manufactures do not have to minimise potential peanut protein contamination even further to prevent allergic reactions in the presence of cofactors like sleep deprivation.”

Southampton researchers are looking to improve the prevention and treatment of lung and airway infections. They plan to do this using the knowledge and experience gained by treating people in hospital with COVID-19. The UNIVERSAL study aims to better understand how and when viral lung and airway infections progress to more serious disease. It will also help develop effective antiviral treatments to combat these infections. The study is being led by Tom Wilkinson, Professor of Respiratory Medicine at the University of Southampton. Professor Wilkinson a key researcher at the NIHR Southampton Biomedical Research Centre. Identifying patients who may become seriously ill University Hospital Southampton was the first hospital to open the study last week. It has already recruited the first patient. Overall, the study is aiming to recruit 1,000 patients who test positive for a viral respiratory infection. It will involve up to 10 hospital sites around the UK. Patients admitted to hospital with respiratory infections will have blood and swab samples taken. The researchers will analyse these samples for signs of the body's immune and inflammatory responses. The patients will also be assessed by medical teams and fill in questionnaires. This will help track their symptoms and any progression of the infection. The researchers hope to use this information to identify patients who may become seriously ill. This could help predict their recovery and length of stay in hospital. It could also help them understand which viruses are affecting the population. “As seen over the course of the pandemic, individual response to respiratory virus infection is variable from patient to patient,” says Professor Wilkinson. “This can range from mild, self-limiting symptoms to severe infection requiring hospital care. There is a real need to better understand this patient journey, and to understand what drives these differences. This will enable the development of new, more effective therapeutics for respiratory viral illness beyond COVID.” Working with Synairgen UNIVERSAL is being supported by Southampton-based respiratory company Synairgen. It is investigating an inhaled antiviral as a potential treatment for hospitalised patients with COVID-19. It is also investigating its use in patients with severe viral lung infections. Synairgen is providing viral testing equipment and nursing staff at the Southampton clinical trial site. Richard Marsden, CEO of Synairgen, says: “The COVID-19 pandemic highlighted the important link between research and clinical care, and the impact on the timely development of much-needed antivirals for severe lung viral infections caused by seasonal viruses and emerging respiratory viral threats. "Our collaboration on the UNIVERSAL study will help provide a better understanding of what could predict clinical outcomes in patients hospitalised with respiratory symptoms due to infection with a range of respiratory viruses. The trial will help to further inform the development programme of SNG001, our investigational broad-spectrum antiviral.” UNIVERSAL is funded by Janssen, with support from Synairgen. The Southampton Clinical Trials Unit is supporting the trial. University Hospital Southampton are the sponsor.

Innovative research is supporting teenagers make healthier choices that will help them live well for longer. Southampton researchers are leading the EACH-B programme. It involves fun science activities, support from teachers, a visit to the expert facilities, and access to a specially-designed smartphone app. Experiences from across the research programme are being shared in three new videos. Changing behaviours Poor diet and lack of exercise cost the NHS £7 billion a year and cause many to die early. Habits formed as teenagers tend to last. Physical and psychological changes during these years make it an important time to help them form healthier habits. Making small, sustained changes, such as eating more fruit and vegetables, can reduce risks of heart disease or diabetes in later life. Existing interventions for helping teenagers tend to only work for those ready to change, or who see diet and exercise as important. The EACH-B programme is working with teenagers, their parents and their teachers to engage more young people in eating well and being more active. A new intervention EACH-B - Engaging Adolescents in Changing Behaviour – has developed and is testing a new intervention with teenagers from state secondary schools. The young people take part in a LifeLab three-week science module linked to the national curriculum. This helps 13-14 year olds think about science and their health. They also receive encouragement from teachers trained to support students to improve their diets and exercise plus a specially-designed interactive smartphone app that involves friends and has game features that encourage students to eat better and move more. EACH-B is funded at the University of Southampton by the National Institute of Health and Care Research (NIHR). How to take part Schools can sign up to take part in EACH-B by contacting eachb@soton.ac.uk. Patient and public involvement is also at the heart of EACH-B's work. Teenagers and parent advisors play a key role in developing the research questions and helping make sense of the findings. You can find out more about participating in EACH-B or wider Southampton research by emailing Publicinvolvement@uhs.nhs.uk.

Younger women with non-alcoholic fatty liver disease are at almost five times greater risk of type 2 diabetes, according to new research. This far exceeded that observed in older women and men, who were around twice as likely to develop diabetes if they had the liver condition. The international study also shows for the first time how fatty liver disease can be used to improve risk prediction of type 2 diabetes. Southampton’s Professor Chris Byrne collaborated on the cohort study of over 245,000 people in South Korea. Researchers have published their findings in Hepatology. Progressive liver disease Non-alcoholic fatty liver disease (NAFLD) is the term for a range of conditions caused by a build-up of fat in the liver. It's usually seen in people who are overweight or obese, and is estimated to affect around a quarter of the world’s population. It has four stages, where the liver becomes progressively more damaged. It is known that NALFD can play a role in the development of type 2 diabetes. However the effects of sex and menopausal status on this association remain unclear. Korean cohort study This latest research analysed data from 245,054 adults in South Korea who started the programme without diabetes. The Kangbuk Samsung Health Study included 109,810 premenopausal women, 4,958 postmenopausal women and 130,286 men. Participants were followed for around five years, with 8,381 going on to develop type 2 diabetes. Prof Byrne worked with researchers from Kangbuk Samsung Hospital and the University of Edinburgh on the new findings. Increased risk factor Overall, a diagnosis of NAFLD was found to more than double the chances of someone developing new type 2 diabetes. The addition of NAFLD to conventional risk factors improved risk prediction for type 2 diabetes in both sexes, with a greater improvement in women than men. The analysis found that risk for developing type 2 diabetes was 4.6 times higher in premenopausal women with NAFLD. This compared to a 2.6 times higher risk for postmenopausal women and a 2.16 times higher risk for men. Prof Byrne, Professor of Endocrinology and Metabolism and Honorary Consultant Diabetologist & Metabolic Physician, said: “These striking findings suggest that premenopausal women diagnosed with NAFLD should be considered at high risk of type 2 diabetes, and this group should be targeted for diabetes prevention. “Our study also underscores the need for clinicians to be aware of a possible diagnosis of NAFLD and also to consider age- and sex-specific approaches for diabetes risk assessment and management.” The research was funded by the NIHR Southampton Biomedical Research Centre and Sungkyunkwan University.

Southampton researchers are looking for healthy women to take part in a new trial that could help prevent a common viral infection that can seriously harm newborn babies. Cytomegalovirus (CMV) is a common virus that is usually harmless. But if a pregnant woman has a CMV infection and passes it on to her unborn child, it can cause lifelong disabilities or even death. This is why researchers are inviting healthy women aged 16 to 40 to take part in an international trial of a new CMV investigational vaccine. The study is being run at University Hospital Southampton, together with St George's and St Bartholomew's Hospitals in London. Dr Chrissie Jones, Southampton lead for the trial, said: “A vaccine against CMV is a high priority to prevent the life-long problems for some children who catch CMV before they are born. We are inviting healthy women to participate in this CMV trial and hopefully make a difference to families in the future who will not have to experience the consequences of CMV infection.” What is cytomegalovirus? CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. It is unusual for a CMV infection in a healthy person to cause illness, but when it does it can cause a flu-like illness, with a fever, muscles aches and fatigue. However, if a pregnant woman has a CMV infection, it may be passed on to her unborn child. This causes the baby to be born with a CMV infection, known as congenital CMV. It is the most common congenital viral infection. Although most infants who are born with congenital CMV are well, some can develop lifelong disabilities such as hearing loss, learning problems, or vision abnormalities and may even die. Preventing infection from young children There is currently no approved vaccine to prevent CMV infection. If such a vaccine could be developed, it may be able to prevent children being born with a CMV infection. The most common source of CMV infection in pregnant women is young children. Young children commonly catch CMV and can shed the virus in their saliva and urine for long periods of time. The researchers aim to recruit people who are aged 16 to 40 age and are generally healthy, who are not pregnant (as protection is needed before pregnancy) and agree to not become pregnant for 9 months. Those who are >= 20 years, must have contact with young children. The researchers aim to assess the safety of this investigational vaccine and how effective it is at preventing CMV infection. Southampton will be one of around 150 study sites in various countries, with around 6,900 healthy participants expected to take part overall. Taking part The trial is being delivered locally by the NIHR Southampton Clinical Research Facility based at University Hospital Southampton NHS Foundation Trust. To join this clinical trial, you must be: • A woman between 16-40 years of age • In good health • In close contact with at least one child five years of age or younger for at least eight hours a week, if aged 20 or older • Not pregnant or planning on becoming pregnant within the next nine months Participants will receive a total of three separate injections into the muscle in the upper arm over a period of six months. They will be randomly allocated to receive either the investigational vaccine or a placebo. Participation in the study will last about 30 months (two and a half years), and involve approximately 14 on-site visits. The study team will also contact participants for safety data, either by telephone or through receipt of electronic diary (eDiary) safety survey messages. Participants will be reimbursed for any reasonable expenses incurred as a result of taking part in this trial, and receive payments for completing some aspects, such as surveys. For more information, please contact UHS.RecruitmentCRF@nhs.net or call 02381204989.

People who eat a lot of acrylamide, found in unhealthy food like crisps and chips, have been shown to be more likely to break a bone. A team of researchers, including Prof Cyrus Cooper from the NIHR Southampton Biomedical Research Centre, studied the diet and fractures of thousands of people over eight years. Their results suggest that cutting down on highly processed ‘junk’ food could help people keep their bones stronger in later life and reduce their risk of fractures. What is acrylamide? Acrylamide is a component of unhealthy carbohydrate-rich foods that are deep fried, baked or roasted, such as crisps and chips. There is already evidence linking it with a higher risk of cancer, as well as poor outcomes in pregnancy and soon after birth. This study used data on 4,436 participants in the USA from the Osteoarthritis Initiative database, collected between February 2004 and May 2006. They ranged from 45 to 79 years of age, and all either had, or were at high risk of developing, knee osteoarthritis. Each participant answered questions on what they ate in a food frequency questionnaire. The researchers used this to estimate how much acylamide they consumed, and then recorded how many bone fractures they had in the following eight years. Linking the data A total of 789 osteoporotic fractures were recorded during the eight years. Those who ate a lot of acrylamide had significantly more fractures than those who ate very little acrylamide. The results are published in the journal Aging Clinical and Experimental Research. Prof Cyrus Cooper said: “The important findings from this study provide new evidence suggesting acrylamide could be bad for bone health. Cutting down on unhealthy food containing acrylamide may therefore be a good way to help prevent fractures in older age.”