Research studies in vaccine safety

Q fever – essential vaccine safety research to inform Australia’s Q fever policy

This study aims to enhance our knowledge on the adverse events profile of Q fever vaccination in young adults and women.

Currently, the lower age limit for administering the Q fever vaccine is 15 years of age and there is a lack of data on adverse events following immunisation (AEFI) for those aged 15 to 25 years, particularly women. Most of the AEFI data comes from clinical trials in male abattoir workers and farmers and also from passive surveillance systems which are known to underestimate AEFIs.

Before any future change in recommendation can be made to expand the Q fever vaccination program from occupationally based to community-wide, extra data on the safety of Q fever vaccine in young adults, particularly women, is needed.

This work is being undertaken with veterinary colleagues at the University of Sydney, Charles Sturt University and the University of Queensland. In this study, young (17–25 years old) veterinary students, predominantly women, in NSW and Queensland are being followed up after vaccination using an internet-based survey tool. Students are asked to complete an online questionnaire 1 week after receipt of the Q fever vaccine to assess for any AEFI. To date, 450 students have been enrolled into this study and data analysis is currently underway.

Febrile seizures following vaccination in children: How common are they and what is the long-term clinical outcome?

As the incidence of vaccine preventable diseases declines due to the success of vaccination, adverse events following immunisation (AEFI) assume increasing importance. Public and provider concern about serious AEFI, such as seizures, impacts negatively on vaccination coverage rates and has resulted in outbreaks of vaccine preventable diseases.

Febrile seizures can occur following both live attenuated and inactivated vaccines. Importantly, this study will address the lack of available information on long-term clinical, neurodevelopmental outcomes and recurrence rate (with revaccination) in children who experienced a febrile seizure after vaccination.

In addition little is known about the genetic markers in children who have had seizures soon after vaccination. The most likely gene mutation, based on previous small studies, is a sodium channel gene mutation (SCN1A). This study is using the internationally recognised expertise of the Epilepsy Research Centre in Melbourne to investigate these genetic mutations in children who have had a febrile seizure following vaccination. This is a multi-site study involving investigators in Adelaide, Perth, Sydney and Melbourne.

Three groups of children are currently being enrolled into the study: children who have had a febrile seizure after vaccination, children who have had a febrile seizure not related to a vaccination, and healthy controls. Participating children will have a formal developmental assessment by a psychologist and genetic testing to assess for the SCN1A mutation. The results of this study, particularly long-term outcomes, are extremely important for parents and healthcare providers and are essential to maintain public confidence in vaccines.

 

Last update June 2016