A clinical trial seeking to develop an mRNA vaccine for preventing cytomegalovirus (CMV) infection.
About this study
CMV infection is a common infection that can spread through saliva, blood, urine and breast milk. An infected healthy carrier normally has no symptoms but symptoms may develop and include:
- Muscle aches
- Moderate to severe fatigue
- Sore throat or swelling at back of throat
- Swollen neck glands
Infected pregnant women can infect their unborn child, causing congenital CMV infection.
Infants with congenital CMV infection can have severe lifelong disabilities such as hearing loss, learning problems, vision abnormalities and potentially may be life-threatening, leading to death.
Anticipated enrolment close date: December 2022
Who can take part
You may be able to participate if you meet the following criteria:
- Are a healthy female aged 18 to 40 years of age and are capable of childbearing
- For those 20 years and older will need to have or anticipate having access to a child 5 years of age or under for at least 8 hours per week
- Not currently pregnant and not planning to be pregnant for the next 10 months
You will not be able to participate if you meet any of the following apply to you:
- Non-child bearing potential
- Anaphylaxis or severe hypersensitivity reaction to vaccine
- Have dermatological conditions (for example, psoriasis patches) or tattoos on upper arms as these can interfere with assessments of injection reaction
- Currently receiving cancer or steroid or antiviral drug treatments
- Received COVID-19 or another vaccine within the last 28 days or flu vaccine in the last 14 days
- Bleeding disorder, psychiatric disorders, drug and alcohol abuse
- Participating in another vaccine clinical trial
- Receive three injections of the trial vaccine or placebo during the first six months
- Attend a total of 13 study site visits and receive five follow-up phone calls over 30 months
- Complete electronic diary eight times over 20 months
- Physical examinations by a doctor during study visits
- Donate study blood samples on some study visits
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.