NCIRS leads, coordinates and participates in vaccine-related clinical research, in collaboration with other research institutions in Australia. This research aims to address gaps in knowledge to inform Australia’s immunisation policy for specific risk groups and management of adverse events following immunisation. Areas of clinical research include:

  • studies to assess the safety and immunogenicity of vaccines when used in 'understudied and special risk populations'  

  • investigation of novel vaccine schedules or strategies to improve vaccine coverage

  • studies on causes and outcomes of adverse events following immunisation.  

These studies are funded by philanthropic organisations or from competitive peer-reviewed grants.

Current clinical studies

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. 

  • How far are we up to: Recruiting (contact Associate Professor Nicholas Wood at nicholas.wood@health.nsw.gov.au for more information)

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. 

  • How far are we up to: Serology collection in progress. 

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.

  • How far are we up to: Recruiting (contact Associate Professor Nicholas Wood at nicholas.wood@health.nsw.gov.au for more information)

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. 

  • How far are we up to: Analysis in progress. 

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. 

  • How far are we up to: Recruiting  

The utility of a statewide immunisation phone advice line

  • Why this study: NSW Immunisation Specialist Service telephone advice line was established more than 2 years ago to provide timely clinical advice to immunisation providers. 

  • What do we want to achieve: Determine the types of enquiries immunisation providers have regarding immunisation, whether providers from particular areas require more clinical support than others and if the advice line adds value to existing public health–based immunisation service provided by local Public Health Units. 

  • How are we doing it: Retrospective analysis of calls made to the advice line in the first 24 months of operation. Information on caller details, type of enquiry and outcomes were collated in a database and analysed for pattern. 

  • How far are we up to: Analysis in progress. 

Early infant pertussis: prevention and outcomes study (EIPPOS)

  • Why this study: Australia has seen a rise in pertussis hospitalisations and deaths in young infants, particularly those aged under 4 months. At the same time, there has been a rise in allergic diseases in Australia. One European study suggested that early infant infection with pertussis led to a higher rate of asthma and atopy compared to age-matched controls. 

  • What do we want to achieve: Determine health outcomes, specifically atopy and asthma, of infants who had pertussis infection in early infancy. 

  • How are we doing it: Telephone survey of parents of infants hospitalised with pertussis to determine the long-term health outcomes, specifically atopy and asthma, compared to age-matched controls who presented with respiratory symptoms who tested negative to pertussis.

  • How far are we up to: Surveys in progress. 

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. 

  • How far are we up to: Ethics approved. 

Last updated December 2018