Research Center: Paratus Clinical
Locations:
Paratus Clinical Kanwal Clinic
Suite A8, Kanwal Medical Complex, 654 Pacific Hwy, Kanwal, NSW, 2259
Paratus Clinical Blacktown Clinic
Level 2, Suite 201, 114-116 Main Street, Blacktown, NSW 2148
Lead Doctors: Dr James Vandeleur (Kanwal), Dr Mariam Chaalan (Blacktown)
Ethics Committee: This study has been reviewed and approved by Bellberry Human Research Ethics Committee

Background

Vaccines can help to provide immunity against one or several diseases. The study is looking to understand if a new vaccine is effective in preventing healthy women from getting cytomegalovirus. This study is also testing how your body handles the vaccine and if the vaccine is safe.

Cytomegalovirus (CMV) is a common virus. Many people do not know they have it, because they may have no symptoms. Cytomegalovirus is a concern for pregnant women as it can pass on the virus to the unborn baby. A woman who develops an active CMV infection during pregnancy can pass the virus to her baby, who might then experience signs and symptoms. There are medications to treat newborns, however there is a need for more preventative care to reduce the spread of the virus. However, CMV can have complications that are not treatable. CMV can cause long term health problems in babies which can include: vision problems, hearing problems, issues with the nervous system.

This research is looking to understand if a vaccine can reduce the amount of cases of cytomegalovirus in women and thus prevent the virus from being passed to newborns.

This study seeks females aged 16-35. Participants are required to attend 8 study visits at the research site over a 3 year period and will be reimbursed to help cover the cost of travel and expenses for participating in this study.

Why Participate?

• You will be helping to develop preventative care methods for this virus.
• You may be helping to prevent this virus from spreading to newborns.
• You will be helping researchers better understand how to protect women and their children from cytomegalovirus
• You will be reimbursed to help cover the cost of travel and expenses.
• When attending the screening visit, you will be informed if you already have the virus
• You will be helping to advance medical research.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Women aged 16-35 who are in good health
• Have direct contact to young children (≤5 years of age) at home or occupationally
• Able to attend 8 study visits at the research site over approximately 3 years