Our work

• COVID-19 vaccine trials

  NCIRS and the Sydney Children's Hospitals Network (SCHN; the Network) will be involved in a number of COVID-19 vaccine clinical trials in Australia in the near future. In preparation, the Network is seeking expressions of interest for potential participation from people living in Australia.

  Enrollment will likely be for people who are:

  • aged between 18 and 84 years
  • generally healthy
  • prepared to attend on site for vaccinations (there may be same occasions when a home visit would be possible)
  • able to manage an app on their phone for recording symptoms (or an electronic device if one was provided).

   

  If you and/or members of your immediate family are interested, please send through your expression of interest to SCHN-NCIRS-Research@health.nsw.gov.au.  Please include your age in the email, within one of the following categories:

  • 18–59 years
  • 60–69
  • 70–79
  • 80–84

   

  The NCIRS team will be in touch with everyone who registers interest with more definite details about COVID-19 vaccine trials as more information becomes available.​ Please note we are currently not running any COVID-19 vaccine trials. 

  For any further questions, please email SCHN-NCIRS-Research@health.nsw.gov.au.

• Other clinical trials

  The Clinical Research team at NCIRS will be involved in a number of clinical trials in the near future. These trials may include new vaccine trials, surveillance studies and well-being studies. 

  If you are interested in participating in a clinical trial, please complete an expression of interest form. You will be required to enter your details and select which potential trials you may be interested in. 

  Expression of interest form

  We will get in touch with you when clinical trials of interest to you are being conducted to provide more details. 

  For any further questions, please email SCHN-NCIRS-Research@health.nsw.gov.au
   

• OPTIMUM Study 

  Examining how giving a 'whole cell' pertussis vaccine instead of 'acellular' at 2 months of age can help protect children from developing allergies
   

  Why this study

  The number of children suffering from food allergies appears to have risen greatly in the last 20 years. Statistics now show up to 3 in every 10 Australian children develop either a food-related allergy or eczema. Allergies occur when the immune system reacts to everyday substances such as different types of food. Researchers believe that by harmlessly mimicking infections, some vaccines have the potential to help steer the immune system away from developing reactions.

  What do we want to achieve 

  The OPTIMUM Study aims to determine whether giving one dose of 'whole cell' pertussis (whooping cough) vaccine at 2 months of age instead of the current 'acellular' pertussis vaccine can help train the immune system and protect young children from developing allergies.

  How are we doing it

  The OPTIMUM study hopes to enrol up to 3,000 Australian babies aged 6–12 weeks to take part in the trial. Participants will receive all routine baby and toddler vaccines and will be assessed, including by skin testing, to see whether they develop food allergies or eczema by 18 months of age. Babies will be randomly assigned to receive either one dose of whole-cell whooping cough vaccine at 2 months of age, followed by two doses of acellular vaccine, or just have the usual schedule of three doses of the acellular whooping cough vaccine. Participation will involve up to 4 visits at the study clinic.

  Who can take part 

  • Healthy babies aged 6–12 weeks of age (born after 32 weeks gestation)
  • No diagnosed food allergies 
  • Not yet received their 6–8 week vaccines
     

  Where are we up to

  Recruiting. If you are currently pregnant or have recently had a baby and would like to participate, please register here. You can also contact the NCIRS Clinical Research Team on 0423 799 327 or email us at SCHN-OPTIMUM@health.nsw.gov.au.SCHN-OPTIMUM@health.nsw.gov.au.  
   

• Influenza Imprinting Study (IMPRINT)

  Examining how prior infection or vaccination with Influenza (the flu) impacts a person’s immune system

   

  Why this study

  Most children experience their first influenza (flu) virus infection in the first 5 years of their life. Recent data suggest that your child’s first exposure to a flu virus influences their immune response to any flu vaccine. While this has been described in mathematical modelling studies, it has yet to be confirmed in patient clinical studies.

  What do we want to achieve

  Our study looks at if and how prior flu infection or vaccination affects children’s immune response to future flu exposure. It will do so by comparing various groups of children, including those who have already had a flu infection or flu vaccine, or neither of them. By understanding your child’s immune response, the study will better guide doctors’ and scientists’ efforts in reducing the impact of flu on children and adults in the future.

  How are we doing it

  We are running the Influenza Imprinting Study again this year and need children who fit into these groups:

  • Group 1: had Influenza A last year or before 
  • Group 2: had flu vaccination last year or before 
  • Group 3: has never had flu infection or vaccination
  • Group 4: currently has confirmed Influenza A infection

   

  The study runs over 2 years and involves flu vaccination and up to three blood tests each year. Some visits may take place while your child is an inpatient (if applicable), while you are attending the Immunisation Drop-in Centre or you may be asked to come into The Children’s Hospital at Westmead.

  Where are we up to

  Recruiting: For more information please contact the research team at SCHN-CHW-CIERS@health.nsw.gov.au

• Flu vaccine in healthcare workers

  Examining immune response to flu vaccination among hospital workers

   

  Why this study 

  Healthcare workers are advised to receive annual seasonal influenza vaccine to protect staff and patients from infection. Some evidence suggests antibody responses to influenza vaccine may decrease with repeated vaccination; however, little is known about how this occurs.

  What do we want to achieve

  To study how the immune system and effectiveness of the vaccine is influenced by prior vaccination experience.

  How are we doing it

  We are participating in a multi-centre study conducted by the WHO Collaborating Centre for Reference and Research on Influenza. Healthcare workers are recruited prospectively during influenza vaccination campaigns. Immune responses to the influenza vaccine and infection are determined through blood testing. Participants are followed up and tested via a nasal swab to establish whether they develop influenza illness. 

  Where are we up to

  Recruiting: Please e-mail us at  SCHN-NCIRS-Research@health.nsw.gov.au with your phone number and e-mail address and a member of the NCIRS clinical research team will be in touch with you.

  Please note that we are only recruiting hospital workers from The Children’s Hospital at Westmead.

• Q fever

  Safety and immunogenicity of Q fever vaccine in children 10 to 15 years old

   

  Why this study

  Q fever is a highly infectious disease caused by Coxiella Burnettii, with more than 450 cases notified in Australia annually. There is an effective Q fever vaccine, QVax, which is recommended for those considered to be in “occupational at risk” groups, such as abattoir workers, veterinarians and farmers. Currently QVax is only licensed for those older than 15 years, as initial trials did not include children. Therefore, children younger than 15 years who are at risk of contracting Q fever, because they live on farms, near abattoirs or are children of “at risk” workers, are not recommended to be vaccinated. 

  What do we want to achieve

  Determine the safety and immunogenicity (immune responses) of a Q fever vaccine in children aged 10 to 15 years old. 

  How are we doing it

  Healthy children aged 10–15 years who are at potential risk for Q fever are recruited to receive QVax, following the routine pre-vaccination skin test and serology screening. Serial serology testing performed 7 and 13 months following vaccination. 

  Where are we up to

  Recruiting (contact Associate Professor Nicholas Wood at nicholas.wood@health.nsw.gov.au for more information)

• Immumum

  Essential research to inform the impact of immunosuppressive medications taken during pregnancy on maternal and infant immune responses to vaccines

   

  Why this study

  Maternal vaccination against influenza and pertussis is our primary strategy to prevent these infections in young infants. However, information on the safety and immunogenicity of influenza and pertussis vaccination in pregnant women taking immunosuppressive medications and immune responses to vaccines in their infants is lacking because as a group they are excluded from drug trials.

  What do we want to achieve

  Assess the safety and immunogenicity of influenza and pertussis vaccination in pregnant women taking biological disease modifying anti-rheumatic drugs (bDMARDs) and the immune responses to vaccines in their infants.

  How are we doing it

  Prospective multicentre recruitment of pregnant women on immunosuppressive medication to determine antibody responses to acellular pertussis (dTpa) and influenza vaccines during pregnancy and antibody responses in infants of these mothers following their routine infant vaccinations through serology testing.

  Where are we up to

  Recruiting (contact Dr Ketaki Sharma at ketaki.sharma@health.nsw.gov.au for more information) 

• The BRACE Trial

  BCG vaccination to reduce the impact of COVID-19 in healthcare workers 

   

  The BCG vaccination to Reduce the impact of COVID-19 in healthcare workers following Coronavirus Exposure (BRACE) trial was launched by Murdoch Children’s Research Institute (MCRI). The clinical trials teams at NCIRS and Kids Research, Sydney Children’s Hospital Network will be coordinating the trial in NSW with the other sites across Sydney that will be involved, including Westmead Hospital, Sydney Children’s Hospital Randwick, Prince of Wales Hospital and St Vincent’s Hospital.

  Why this study

  Healthcare workers are at increased risk of contracting COVID-19, caused by SARS-CoV-2. Currently, there are no vaccines or proven preventative interventions available to protect healthcare workers.

  The BCG vaccine is one of the most widely used vaccines in the world, given to over 130 million babies worldwide each year. In addition to preventing tuberculosis, this vaccine also boosts immunity against a variety of other infections.

  What do we want to achieve

  The purpose of the BRACE trial is to find out whether BCG vaccination protects against COVID-19 or reduces severity of COVID-19 in Australian healthcare workers.

  How are we doing it

  In total, the randomised controlled trial will test 10,000 healthcare workers across Australia, and other countries, including the Netherlands and Spain. Half of the participants will receive the BCG vaccine while the other half will receive a placebo. Participants will then be tracked over a period of 12 months to record if they contract COVID-19 and the severity of their symptoms.

  Where are we up to

  Visit the MCRI website for more information

• Alternative pertussis schedule

  Response to a booster dose of DTPa-IPV at 4 years old and persistence of immunity following a new approach to an optimised pertussis vaccination schedule in healthy infants: a follow-up study of optimising pertussis vaccination in infants – a new approach

   

  Why this study

  Pertussis is one of the most contagious vaccine preventable diseases. Australia has recently experienced an epidemic of pertussis. Infants too young to be fully vaccinated and children who are aged 3–5 years are at highest risk for becoming severely unwell from whooping cough.  

  What do we want to achieve

  Compare the immune protection levels at 18 to 36 months and at 4 years old between children who received the alternate pertussis vaccination schedule and those who received the standard vaccination schedule. We will also aim to compare the immune responses after the 4-year -old's booster dose of the diphtheria-tetanus-pertussis-polio vaccine 1 month after vaccination.  

  How are we doing it

  Patients who completed the Optimising pertussis vaccination infants study are recruited to have serology testing before the 4-year DTP-IPV vaccine and 1 month after to determine the immune protection to diphtheria, tetanus, pertussis and polio. 

  Where are we up to

  Data analysis in progress. 

• Post-vaccination seizures

  Characterising clinical presentation and outcomes of children presenting with seizures following vaccination

   

  Why this study

  Febrile seizure risk following vaccination within a defined period after vaccination when a fever peak is well recognised. Only recently, however, have afebrile seizures and prolonged seizures been reported following vaccinations. In a landmark Australian study, SCN1A-associated Dravet syndrome was associated with post-vaccination seizures in the first year of life, especially within 48 hours of DTP vaccination. Little is known, however, on the proportion of children with status epilepticus following vaccination, whether they proceed to have genetic testing and whether these children continue to have their routine vaccinations in a timely manner.

  What do we want to achieve

  Determine the proportion of children who present with status epilepticus following vaccination subsequently get diagnosed with Dravet syndrome and what their re-vaccination outcomes are

  How are we doing it

  Retrospective clinical chart review of children presenting to tertiary paediatric hospitals with status epilepticus following vaccination or to a Specialist Immunisation Clinic with a history of seizures to determine their clinical progression and revaccination outcomes. 

  Where are we up to

  Data analysis in progress.

• Assisted vaccination

  Vaccination of difficult to vaccinate children – a qualitative review

   

  Why this study

  Children who have behavioural disorders or severe needle phobia require a spectrum of distraction techniques, counselling, premedication and/or sedating medical agents to assist with vaccination. There are no guidelines on the most effective approach to or management of these children. The immunisation service at The Children’s Hospital at Westmead developed a pathway for these children to be safely vaccinated. 

  What do we want to achieve

  Assess the effectiveness and patient experience through this proposed pathway. 

  How are we doing it

  Families and immunisation providers are interviewed using semi-structured interview technique by a developmental paediatrician external to the service regarding their experience through this immunisation pathway. 

  Where are we up to

  Data analysis in progress.

• VR distraction for procedural sedation

  Virtual reality as a distraction technique for children requiring procedural sedation

   

  Why this study

  A proportion of children have severe needle phobia that prevents completion of their immunisation schedule, putting them at risk of vaccine preventable diseases. At present, these patients attend multiple clinical appointments and receive premedication or sedating medical agents to assist with vaccination. The introduction of non-pharmacological means of reducing peri-procedural anxiety may decrease the need for medical intervention, enhancing patient and parent experience. 

  What do we want to achieve

  Determine if the use of virtual and augmented reality applications can remove the need for pre-medication for their routine immunisations. 

  How are we doing it

  Children with existing needle phobia are recruited to design their own augmented reality experience and use this during their planned immunisations at The Children’s Hospital at Westmead.

  Where are we up to

  Data analysis in progress

• Waratah Vaccine Trials Alliance

  The Waratah Vaccine Trials Alliance was established in 2020 in response to the growing need for a coordinated approach to clinical vaccine trials in NSW made urgent by the COVID-19 pandemic. The pandemic created a critical need to have the capability and infrastructure in NSW to attract and conduct COVID-19 vaccine trials for the benefit of Australia and internationally.

  The short-term goal of the alliance is to facilitate the rapid conduct of COVID-19 specific and related vaccine trials of both pharmaceutical industry sponsored and investigator-initiated vaccine candidates.

  The first trial to commence under the Waratah alliance banner (involving five NSW hospitals) was the BRACE trial, an international collaborative trial investigating the potential for the BCG vaccine to protect against COVID-19 in healthcare workers.

  The Waratah Vaccine Trial Alliance will act as a hub for the future of vaccine trials in NSW.

  Our vision and mission

  Our vision is to improve population health through the conduct of high-quality, collaborative clinical vaccine trials in NSW and Australia.

  Our aims are to:

  • establish NSW as a premier site in Australia for vaccine trial research
  • increase access to clinical vaccine trials for the population of NSW
  • provide an efficient, high-performing clinical trial alliance in which to conduct both industry-sponsored and investigator-initiated vaccine trials
  • provide education, training and mentorship to the next generation of vaccine researchers
  • engage with consumers to optimise the design and conduct of vaccine trials
  • facilitate the translation of the results of vaccine trials into policies and programs for our population.

   

  Our members

  The alliance is a multidisciplinary collaboration of leading and emerging clinical vaccine trial researchers, consumers and other stakeholders. We consist of a core group of researchers who design and lead clinical trials and members who participate by recruiting participants to the trials in a given vaccine portfolio.

  Current participating urban hospital sites include: the Sydney Children’s Hospitals Network (SCHN), Westmead Hospital, St Vincent’s Hospital and Prince of Wales Hospital.

  The alliance plans to include new sites in both urban and regional/rural locations, both hospital- and community-focussed, in NSW.

  Industry and investigators are invited to approach the alliance coordination team with a vaccine trial that they wish to be conducted under alliance capabilities. Please email SCHN-NCIRS-Research@health.nsw.gov.au.