Testing new treatments, drugs and devices

IHMRI’s well-equipped Clinical Research and Trials Unit (CRTU) offers facilities and services for a range of clinical research studies and commercial clinical trials. Our region’s stable and accessible population base, which is set to grow to over 465,172 by 2036 (Wollongong City, Shellharbour City and Shoalhaven City Councils), demographic and economic diversity, and incidence of chronic disease, makes it ideal for population health studies and clinical trials. Read more about our region. Members of the community who are interested in taking part in clinical trials can read more at Participate in clinical trials.

Clinical trials now recruiting

There are a number of clinical trials conducted within IHMRI to test new drug therapies, vaccines, screening procedures and medical devices. We are often looking for participants with both good health and those living with existing health conditions, to help us test new treatments. Below are list of studies now recruiting for participants.

The research project is testing the safety, tolerability and immunogenicity of intramuscular (into the muscle) injections of a booster vaccine for COVID-19. The new experimental mRNA vaccine is called CV0501. The vaccine is developed by CureVac (a biopharmaceutical company) and GSK (GlaxoSmithKline) Biologicals SA. Key selection criteria:

  • Is a healthy male or nonpregnant female ≥18 years old
  • Not pregnant or breastfeeding
  • Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®), with the last dose of vaccine received at least 6 months prior to
  • Has NOT received AstraZeneca COVID-19 vaccine. 
  • Negative for SARS-CoV-2 or COVID-19 infection by RT-PCR test at screening
  • Not has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
  • Not has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening.
  • Not has received or plans to receive any licensed vaccine within 4 weeks before or 4 weeks after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.

This research study is testing an experimental vaccine that can potentially prevent COVID-19 disease. This experimental vaccine is called RVM-V001. This research study aims to look at the safety and immune responses of RVM-V001. You are invited as a possible participant in this study if you are of good health, have been previously vaccinated for COVID-19, and have not contracted the COVID-19 infection in the last 6 months prior to enrolment.  Who Can Participate?

  • Male and female healthy volunteers
  • Is age ≥18 and ≤ 65 years on Study Day 1
  • Have completed either a 2-dose primary vaccination series with Pfizer or Moderna, OR have completed the primary series and one homologous booster of Pfizer or Moderna; the last dose in all cases should have been administered at least 6 months prior to enrolment.
  • Body mass index of 18-32 kg/m2, inclusive, at screening.
  • Must not have documented history of COVID-19 within 6 months prior to enrolment.
  • Must not have RT-PCR test for COVID-19 within 2 days of screening
  • Must not have received any COVID-19 vaccine other than Pfizer or Moderna.
  • Must not have received more than 3 doses of any mRNA (eg. Moderna) COVID-19 vaccine.
  • Must not be pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial.
  • Must not have history of infection of Middle East respiratory syndrome (MERS), or Severe Acute respiratory syndrome (SARS).
  • Must not have positive serology test results for hepatitis C virus antibody, HIV antibody, hepatitis B virus surface antigen at Screening.

This study will be investigating whether a treatment called Tozorakimab could help manage COPD exacerbations (often called flare-ups, where COPD symptoms get worse) in patients who are currently receiving treatment for COPD. If successful, the findings from this will help in the development of future treatments for individuals with COPD  – now recruiting If you:

  • Individuals aged 40 and above who have been diagnosed with COPD for at least one year
  • Must be a previous or current smoker
  • Must have had at least 1 COPD flare-up in the last 12 months
  • Must be regularly taking inhaled medication for COPD
  • Must not have any other clinically important pulmonary disease other than COPD
  • Must not have a current diagnosis of asthma
  • Must not have a planned major surgical procedure within the next 16 months
  • Must not have had a cancer diagnosis within the last 5 years (some skin cancers and cervical cancers can be included if treated more than 1 year ago) 
  • Must not currently require the use of long-term oxygen therapy
  • Must not have a history of alcohol or substance abuse disorder
  • Must be able to attend 16 study visits at the research site over approximately 62 weeks

Enhance is conducting a research study to evaluate the impact of a nurse practitioner-led memory clinic for people living with dementia and their carer/ families.

The research will be conducted over a 12-month period and participants will be asked to complete a clinical interview every 3-months. These clinical interviews will go for about 90 minutes. The clinical interviews will include questions about cognition, daily function, quality of life, mental wellbeing.

The outcomes of this research will be used to improve services and resources for people living with dementia and their carer/ families. The findings will be presented in journals and at conferences so healthcare professionals can learn from this project.

Please register your interest in taking part via email or phone:

Amy Montgomery

Nurse Practitioner/ Lecturer

E: enhance@ihmri.org.au

T: 0456 845 196

Trials in follow up

  • Shingles Vaccine: Zoster 049 study. A long running trial involving 31,000 people in 18 countries.  Recruitment closed
  • Myovant SPIRIT EXTENSION study: An extension of the SPIRIT 2 study for women with Endometriosis-Associated Pain. Recruitment closed
  • CLEAR – Cardiovascular Study: A study assessing the effects of a new drug on the occurrence of major cardiovascular events in patients who are statin intolerant. Recruitment closed

Past clinical trials

  • Asthma medication study: Using existing medication in a new way to see if asthma management can be improved
  • Over Active Bladder (OAB): Testing safety and tolerability of a new combination of drugs to improve the symptoms of OAB.
  • COMPOSE: A clinical study to assess the safety and potential efficacy of a compound to improve memory, language and learning in people with Down Syndrome.
  • Obesity study: A placebo-controlled weight loss study of an investigational medication.
  • Osteoarthritis study: Assessing the effectiveness of a new drug to relieve pain.
  • Gout study: An evaluation of an investigational drug to see whether, when combined with allopurinol, it reduces high uric acid levels in the blood.
  • Cold sores: Testing an investigational mouth wash to reduce duration of cold sore episodes.
  • Shingles vaccine: A long-running trial involving 31,000 people in 18 countries (the vaccine was shown to be 97 per cent successful in protecting older people from shingles, as reported to the New England Journal of Medicine).
  • Myovant SPIRIT 2 Study: An International Phase 3 Randomised, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a new drug for women with Endometriosis-Associated Pain.
  • Queen Garnet Plum Juice: A randomised controlled trial evaluating the effects of fruit derived anthocyanins for mild cognitive impairment
  • DUPLEX – Renal Study: A randomised, multicentre, double blind, parallel, active control study of a new drug for patients with Primary focal Segmental Glomerulosclerosis (FSGS).
  • ColoSTAT ™️: A simple low cost blood test for the early detection of colorectal cancer.  Developed over 13 years of research by the CSIRO and now being trialled by Rhythm Biosciences
  • Vitamin D and Bone Health Study in Australian Women A landmark study looking at what determines vitamin D status in women by reviewing skin type latitude, diet, and sun exposure
  • Symbiotic Study: SYMptom, microBIOme and dieT in Chronic Kidney disease. A new renal diet designed to improve gut health, diet quality and other clinical outcomes for patients with chronic kidney disease

In the news