Southampton researchers are looking for healthy women to take part in a new trial that could help prevent a common viral infection that can seriously harm newborn babies.
Cytomegalovirus (CMV) is a common virus that is usually harmless. But if a pregnant woman has a CMV infection and passes it on to her unborn child, it can cause lifelong disabilities or even death.
This is why researchers are inviting healthy women aged 16 to 40 to take part in an international trial of a new CMV investigational vaccine. The study is being run at University Hospital Southampton, together with St George's and St Bartholomew's Hospitals in London.
Dr Chrissie Jones, Southampton lead for the trial, said: “A vaccine against CMV is a high priority to prevent the life-long problems for some children who catch CMV before they are born. We are inviting healthy women to participate in this CMV trial and hopefully make a difference to families in the future who will not have to experience the consequences of CMV infection.”
What is cytomegalovirus?
CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. It is unusual for a CMV infection in a healthy person to cause illness, but when it does it can cause a flu-like illness, with a fever, muscles aches and fatigue.
However, if a pregnant woman has a CMV infection, it may be passed on to her unborn child. This causes the baby to be born with a CMV infection, known as congenital CMV. It is the most common congenital viral infection.
Although most infants who are born with congenital CMV are well, some can develop lifelong disabilities such as hearing loss, learning problems, or vision abnormalities and may even die.
Preventing infection from young children
There is currently no approved vaccine to prevent CMV infection. If such a vaccine could be developed, it may be able to prevent children being born with a CMV infection.
The most common source of CMV infection in pregnant women is young children. Young children commonly catch CMV and can shed the virus in their saliva and urine for long periods of time.
The researchers aim to recruit people who are aged 16 to 40 age and are generally healthy, who are not pregnant (as protection is needed before pregnancy) and agree to not become pregnant for 9 months. Those who are >= 20 years, must have contact with young children.
The researchers aim to assess the safety of this investigational vaccine and how effective it is at preventing CMV infection.
Southampton will be one of around 150 study sites in various countries, with around 6,900 healthy participants expected to take part overall.
Taking part
The trial is being delivered locally by the NIHR Southampton Clinical Research Facility based at University Hospital Southampton NHS Foundation Trust.
To join this clinical trial, you must be:
• A woman between 16-40 years of age
• In good health
• In close contact with at least one child five years of age or younger for at least eight hours a week, if aged 20 or older
• Not pregnant or planning on becoming pregnant within the next nine months
Participants will receive a total of three separate injections into the muscle in the upper arm over a period of six months. They will be randomly allocated to receive either the investigational vaccine or a placebo.
Participation in the study will last about 30 months (two and a half years), and involve approximately 14 on-site visits. The study team will also contact participants for safety data, either by telephone or through receipt of electronic diary (eDiary) safety survey messages.
Participants will be reimbursed for any reasonable expenses incurred as a result of taking part in this trial, and receive payments for completing some aspects, such as surveys.
For more information, please contact UHS.RecruitmentCRF@nhs.net or call 02381204989.