A world-first study into the effect of COVID-19 vaccines on vulnerable patients, including the elderly and pregnant women, is underway at the Launceston General Hospital.
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The study is the first of its kind to use systems vaccinology and will incorporate diet, lifestyle and mental health as part of the trial.
The study will be led by Launceston General Hospital Infectious Disease Specialist Professor Katie Flanagan, in partnership with the University of Tasmania's School of Health Sciences, the Royal Melbourne Institute of Technology, Monash University and the Peter Doherty Institute.
While existing COVID-19 vaccines have been approved based on data indicating they are safe, Professor Flanagan said there was a gap in the data for pregnant women and the elderly - both identified as being at-risk groups.
"Pregnancy has been associated with poorer outcomes from COVID, higher rates of intensive care admission, hospitalisation, poorer outcomes for the mother and poorer outcomes for the newborn baby," she said.
"It's a really important target population, but a population that's under-investigated." Professor Flanagan said it was common practice for clinical trials to exclude pregnant women, but the result meant that the data gathered was incomplete.
"Pregnant women are never included initially in clinical trials, which is a very standard thing not to include them, but then you have a data void and you don't know what the vaccine responses are like in pregnancy and how they compare to normal healthy people that are not pregnant," she said.
The study has been funded by the Clifford Craig Foundation, with the $360,000 2-year grant the largest specific medical research grant provided by the foundation in its 30-year history.
Professor Flanagan said the study would help inform future vaccine design and policy and expected to have a significant body of data by the end of the first two years.
"I would hope within two years we would have recruited a significant number of people and we will have some of the primary outcomes answered," she said.
"I will be doing a series of different assays from a more detailed immunological scale, and we'll have also mapped out the microbiome for all the people that are participating in this trial.
"It'll take some time to do absolutely everything and analyse everything, but will have a significant amount of data in this time certainly."
Professor Flanagan said the trial would focus on pregnant women and people over the age of 65, but also required young healthy people between the ages of 18 and 45, and hoped to expand the trial to include other vulnerable groups once established.
People interested in joining the study can contact the Clifford Craig Foundation.
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Andrew Chounding
An experienced multi-platform journalist focusing on the issues that impact health in Tasmania. With a background in social research and public policy, health reporting for Andrew is about ensuring the best health outcomes for the Northern Tasmanian community. Contact Andrew at: andrew.chounding@examiner.com.au or 0437 358 262
An experienced multi-platform journalist focusing on the issues that impact health in Tasmania. With a background in social research and public policy, health reporting for Andrew is about ensuring the best health outcomes for the Northern Tasmanian community. Contact Andrew at: andrew.chounding@examiner.com.au or 0437 358 262
