Participate in Our Trials

Vaccinology & Immunology Research Trials Unit at the Women’s & Children’s Hospital is looking for school aged children 6 to 17 years to take part in a clinical research study looking at the effectiveness of an experimental pertussis (whooping cough) vaccine, given as a fine spray into the nose.

The study will compare the experimental vaccine with a licensed vaccine (BoostrixTM) that protects against tetanus, diphtheria and pertussis.

Participation will last for about 6 months and will include visits to the clinic and telephone calls to check your health.

You will be reimbursed for travel and for your time.

To find out more and check if your child is eligible to participate, check out http://supertrial.net or email virtu@adelaide.edu.au.

Participants required for COVID-19 vaccine booster trial

The Vaccinology and Immunology Research Trials Unit (VIRTU) is partnering with researchers interstate on a new study which aims to evaluate the safety and tolerability of a new investigational DNA vaccine, COVIGEN, which is being developed to protect against SARS CoV-2 virus.

Known as the COVALIA Booster Study, researchers are seeking a total of 50 participants across Sydney, Adelaide and Perth.

Eligible participants must be:

•  A healthy male or healthy female who is not pregnant or who cannot bear children
• Aged 18-75 (inclusive)
• Must be full vaccinated with either Pfizer or Astra Zeneca
• Must have had their last licensed vaccine no less than 3 months before receiving the trial vaccine
• Have no history of alcohol or drug abuse.

The vaccine will be administered intradermally (under the skin) via needle-free high-pressure jet technology.

The study will require 6 visits to the hospital and 1 phone call over a period of 12 months. Participants will be reimbursed for their time and inconvenience.

COVALIA has been approved by the Women’s and Children’s Health Network’s Human Research Ethics Committee.

For further information about the COVALIA study contact Meredith Krieg, Research Nurse (VIRTU) on 8161 7349 or on 8161 6328, or at VIRTU@adelaide.edu.au

Approximately 1 in every 500 children is born with cerebral palsy.

It is now recognised that most cases are associated with factors present before labour begins, and not as a result of events which occur during labour and delivery.

What actually causes cerebral palsy is not clear. In order to determine these factors, it is important to conduct research into the possible causes of cerebral palsy.

The Australian Collaborative Cerebral Palsy Research Group

Type 1 diabetes in children is twice as common as it was 20 years ago. This is because the environment has changed and this has made it more likely that children will develop type 1 diabetes.

If we can understand what factors in the environment are harmful or protective, and how they interact with our genes, we can modify the environment to try to prevent type 1 diabetes.

The ENDIA study is Australia's biggest type 1 diabetes study and is aiming to recruite 1,400 people to discover the environmental triggers for this disease.

The ENDIA study

Does washing blood for transfusion make a difference to preterm babies?

Transfusion with washed versus unwashed red blood cells to reduce morbidity and mortality in infants born less than 28 weeks gestation: a multi-centre, blinded, parallel group randomised controlled trial. 

Investigators

A/Prof Michael Stark, Dr Chad Andersen (Department of Neonatal Medicine, Women’s and Children’s Hospital); A/Prof Carmel Collins, Dr Thomas Sullivan (South Australian Health and Medical Research Institute); Dr Denese Marks (Australian Red Cross Lifeblood); A/Prof Rachael Morton (NHMRC Clinical Trials Centre, University of Sydney); Dr Louise Owen (The Women’s Hospital & University of Melbourne).

Preterm babies often receive a blood transfusion (where blood is given because the blood count falls) during their stay in the nursery. While transfusions save lives in the NICU setting the potential for RBC transfusion related adverse outcomes is an area of growing interest and concern. In sick adults and children, research suggests transfusion with washed blood may reduce illness.

This study will determine the potential for transfusion with washed RBCs to reduce the incidence of transfusion associated neonatal mortality and increase survival free of significant neonatal morbidity compared to current standard transfusion practice.

The blood used for transfusion is extensively screened by the Australian Red Cross Lifeblood Service and is very safe. Both washed and unwashed blood are held by all transfusion laboratories. Both are licensed for use and can be specifically requested at the doctor’s choice.

Learn more about the WashT Trial here

This study has been approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital – HREC/19/WCHN/182

Please direct enquiries and questions to: washt@sahmri.com

Does your health before pregnancy matter? How does it affect your baby? The Begin Better Study is here to find out.

The Begin Better Randomised Control Trial aims to understand whether improving a woman’s health before pregnancy, by changing behaviours related to physical activity and diet, will improve health outcomes for the mother and her baby.

Women who are above the healthy weight range are at increased risk of some pregnancy complications, including high blood pressure, gestational diabetes and caesarean birth, and their babies are more likely to have complications too. Longer term health risks for babies include development of conditions related to metabolic syndrome throughout their lifetime. In addition, women who live with overweight and obesity before pregnancy are additionally at greater risk for many of these adverse outcomes.

It may be that the best way to reduce these health risks complicated by overweight and obesity is to improve a woman’s physical and mental health before becoming pregnant by making positive lifestyle changes to both diet and physical activity.

Participants enrolled in the study will be randomly allocated to either the Lifestyle Intervention Group or the Educational Control Group. All women will attend clinic appointments at the Women’s and Children’s Hospital and receive health recommendations for planning for pregnancy including access to the study website. Those in the Lifestyle Intervention arm of the study will be offered counselling from a dietitian, and health coaching for 6 months. All women enrolled in the study will be followed for a period of up to two years, and if pregnancy occurs in this time, information will be collected about the pregnancy and birth, and their infant until 18 months of age.

To register your interest or for more information
Contact the Begin Better Study team at the Women’s and Children’s Hospital
(08) 8161 8427
beginbetter@adelaide.edu.au

Type 2 Diabetes, a condition typically seen in adults, is becoming more common in young people. There are no studies evaluating the emotional impact of Type 2 Diabetes (called “diabetes distress”) on children and adolescents.

Participants in this study will complete three short questionnaires (a total duration of less than 30 minutes) about their experience living with diabetes and their well being in general. These surveys can either be completed from home (via mail/email) or in-person, depending on preference.

Your participation in this study will give us important information about how living with Type 2 Diabetes affects young people and how we best support the emotional well being of this patient group from the time of diagnosis.

You may be eligible to participate in this study if you:

• Are aged 10-19
• Have been diagnosed with Type 2 Diabetes

For further information, or if you would like to participate, please contact Dana Spajic (Honours Student) at 0413 356 186 or dana.spajic@student.adelaide.edu.au

This study aims to test whether improving nutrient intake of men who are obese can improve sperm quality, without the need for weight loss after 12 weeks of dietary intervention. 

If you meet the study eligibility criteria and consent to participate, you will be scheduled for a first assessment in our clinical rooms, located in the Adelaide CBD at the Adelaide Health and Medical Sciences Building on North Terrace, which will approximately take 30 mins. This will include:

• Online medical and sexual history questionnaires 
• Height, weight, waist circumference measurements
• Body composition measurement by a body image analyser (BIA)
• Fasted whole blood sampling for measurements of glucose, cholesterol and triglycerides
• Blood pressure
• Semen analysis
• Fitted with an actigraphy device (Actiwatch - wGT3X-BT) to monitor daily movements and sleep/awake patterns for a week 
• Provided information about how to record your 3-day food diaries on the mobile phone app Research Food Diary

Following on from this appointment, you will be randomised into either a control or intervention group.

If you are allocated to the control group, you will meet with our clinical trials coordinator who will provide the Australian guidelines on healthy eating, exercise, sleep and alcohol intake plus give you a run-down of the requirements during the 12-week intervention. Following the 12-week intervention, men in the control will also have the opportunity to have an appointment with a clinical dietician for education and administering of nutrient diet plans. 

If allocated to the intervention group you will be prescribed the CSIRO Total Wellbeing Diet for Men and be allocated to four appointments with a clinical dietician from the CSIRO over a period of 12-weeks for nutritional prescription and maintenance of body weight. 

Additional requirements of men during the 12-week intervention include recording of 3-day food diaries (Research Food Diary) every 2 weeks (Baseline, 2, 4, 6, 8, 10, 12 weeks) and weekly at home measurements of body weight. 

At each semen sample collection point (Week 1 and Week 12), you will receive a free semen analysis, and, once your participation in the study is completed (Week 12), you will receive a total of $150 in Coles/Myer gift vouchers to thank you for your participation.

Eligibility requirements

You may be eligible to participate in this study if you:

• are male
• are aged 18-55 years
• have BMI >30

For further information, or if you would like to participate, please contact:

Nicola Mathews, nicola.mathews@adelaide.edu.au (include 'D4Ds' in the email subject line).

Have you had an MRI and/or an Ultrasound for pelvic pain? Or, are you planning to have surgery for pelvic pain in the next six months?

If so, you could be involved in the IMAGENDO Study.

Currently, the recommended way of diagnosing endometriosis is to perform keyhole surgery and view the endometrial deposits inside the abdomen, ideally verified by microscopic examination of the tissue. This method is recommended for the diagnosis of endometriosis but surgery can be problematic, difficult to access, and is associated with delays. 

The Imagendo study will use machine learning to automatically digitally combine the diagnostic capabilities of pelvic scans and magnetic resonance imaging (MRI) to identify endometriosis lesions. Machine learning is an application of artificial intelligence (AI) that provides systems the ability to automatically learn and improve from experience without being explicitly programmed. 

Visit imagendo.org.au to learn more.

Do you have a new baby who is yet to receive their first scheduled vaccinations?

The Women’s and Children’s Hospital and The University of Adelaide are looking for healthy mums and their young babies to take part in an important study aiming to give young babies vital protection against Influenza.

Babies are at risk of life-threatening complications from influenza. The FluBub study will investigate whether giving babies the influenza vaccine, licensed and recommended from 6 months of age, earlier will provide much-needed protection from influenza.

If you have a new baby who is yet to receive their first scheduled vaccinations, we would love to hear from you. To find out more contact virtu@adelaide.edu.au or call Donna Martin on (08) 8161 6328.

Are you a healthy male, aged between 18 and 45 years?

We are currently seeking volunteers in good general health aged 18-45 years for our research study that seeks to better understand the male contribution to a healthy pregnancy.

Male semen plays an important role in preparing the female immune system for a healthy pregnancy. We are interested in determining the identity of the key factors in semen that are responsible for initiating the female immune response.

If after reading through the patient information sheet you wish to participate in this study, you will be asked to produce up to four (4) individual semen samples over a period of approximately six (6) months. You will also be asked to complete a brief questionnaire relating to your fertility status and lifestyle habits.

Semen samples are able to be produced in the comfort of your own home and then dropped off at our study site, located at the Adelaide Health and Medical Sciences (AHMS) building, cnr George Street and North Terrace, The University of Adelaide.

After each sample donation, you will receive a $25 Coles-Myer gift voucher as an honorarium for your time.

To find out more information about this study, please visit: https://is.gd/semen_study or if you have any questions about the study please email PhD candidate Hannah Lyons (hannah.lyons@adelaide.edu.au).

This study has been approved by the human research ethics committee of the University of Adelaide – approval number H-2022-03

This study is seeking:

• Adults aged 50 or over interested in having a third booster dose

• Adults aged 18 or over who have not had a second booster dose

• Teenagers aged 12 – 17 who are interested in having a 1^st booster dose

The Vaccinology and Immunology Research Trials Unit (VIRTU) at the Women’s and Children’s Hospital is investigating the most effective, long-term strategies for booster vaccinations to find out whether:

• Immunity can be maximised by ‘mixing' vaccine booster types and how long this protection lasts.
• How strategies may need to differ depending on age and previous COVID-19 vaccines.

For more information about PICOBOO, please email VIRTU@adelaide.edu.au or call Meredith Krieg on 8161 7349 or Arockia Sugantharaj on 8161 7452. You can also fill in an Expression of interest form: https://redcap.link/PICOBOOAdelaide

This study has been approved by the Child and Adolescent Human Research Ethics Committee. Any person with concerns or complaints about the conduct of this study should contact the Executive Director of Medical Services via [08 6456 2222] who can refer your concerns to the HREC monitoring the project.

Does your health before pregnancy matter? How does it affect your baby? 
The Begin Better Study is here to find out.

Visit the Begin Better study page for more information.