CMVictory Study

Cytomegalovirus, known as CMV, is a common viral infection that usually goes unnoticed or only causes mild, flu-like symptoms.

Despite being harmless for many, CMV can be very dangerous for pregnant woman and their babies. If a woman becomes infected with CMV during pregnancy, the virus can pass to her unborn baby, causing long-term disabilities, hearing loss, or even death in severe cases. It is one of the leading causes of birth defects around the world, and there is currently no vaccine to protect against the virus.

When a person contracts CMV, the virus stays in the body and can reactivate if the person develops problems with their immune system later in life.

What will researchers investigate?

The CMVictory Study aims to learn more about the safety and effectiveness of a potential CMV vaccine.

Researchers will evaluate if the investigational vaccine can help the body develop an immune response against CMV, especially in women who have previously been exposed to the virus.

This information will then be used to inform future studies focusing on vaccination against CMV in pregnancy, similar to influenza and whooping cough, in the hopes of protecting future generations from the potential birth
defects caused by CMV.

Who can take part?

Healthy women aged between 16 - 40 are encouraged to participate in the CMVictory Study.

Participants aged 20 years and over must have close contact with a child aged five years or under for at least eight hours a week.

Women taking part in this study must not be pregnant or planning a pregnancy within the next 10 months.

What does the study involve?

Participation in the study will last around 2.5 years and involve:

• Six visits to the study clinic at Perth Children’s Hospital during the
  first seven months, including an initial screening appointment and three
  vaccination visits. Participants will be divided into two groups according to their previous exposure to CMV, and will be randomly assigned to receive the investigational vaccine or a placebo.
• Study clinic appointments every three months for the remainder of the study period. These visits will vary depending on group allocation but may involve blood tests and providing urine samples to assess the presence of CMV and potential immune responses.
• Follow-up phone calls for health checks and electronic diary prompts
  throughout the course of the study.

Participation in the study is voluntary and reasonable travel and parking costs will be reimbursed.

Have there been any previous studies?

The CMVictory Study is a Phase 3 trial which means it is the final stage of research before seeking approval to license for public use.

Earlier Phase 1 and 2 trials involving the investigational vaccine have found it to be generally well-tolerated without serious side effects.

Safety is our top priority and all participants will be closely monitored by the study doctors.

Does this study have ethics approval?

This study has been approved by the ethics committee at Monash Health.

For more information, please contact the study staff at
the Vaccine Trials Group by calling 0400 450 240 or emailing CMVictory@telethonkids.org.au