Bradford clinicians are part of an international study to protect babies against serious respiratory disease.
The HARMONIE Research Study is looking at how strongly babies can be protected from serious illness due to RSV infection (respiratory syncytial virus) by giving them a single antibody dose.
Bradford Teaching Hospitals NHS Foundation Trust is proud to be one of the recruiting centres taking part in the study, which is aiming to involve as many as 28,860 babies, from newborns to babies 12 months old across the UK, France and Germany.
The Trust’s Lead Research Nurse, Children’s Team, Rachel Wane said:
RSV is a common seasonal virus that infects nearly all babies by their second birthday.
Most of the time it causes a mild illness, like a cold. However, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia. It can make some babies quite poorly and lead to them coming into hospital.
RSV infection is unpredictable and is a leading cause of hospitalisations in babies. Most hospitalisations due to RSV occur in otherwise healthy babies, and it is difficult to know which babies will develop severe disease requiring medical care.
Rachel added that the Trust hoped to recruit 25 babies to the study, which is supported by the National Institute for Health Research (NIHR), by 1 January 2023.
She said:
Antibodies are found in the blood and are part of our immune system, which helps our bodies fight infection and illness. The antibody dose in the HARMONIE Study acts in the same way as the antibodies within our own bodies, but it is targeted specifically to fight RSV.
If the study is appropriate for the baby, they will be randomly assigned into one of two groups. One group will receive the antibody dose by having an injection into their thigh, in the same way babies receive their routine vaccination injections, and in the other group no injection will be given. Putting the babies into two groups in this way ensures there is no bias as to which group the babies are assigned.
Recruitment to the study is now being carried out via Bradford Royal Infirmary’s neonatal unit and the hospital’s post-natal wards as well as through community midwives and ante-natal clinics.
The study lasts around 12 months and involves parents making one visit to the study site with their baby, keeping a monthly diary for six months and a telephone call with the study team 12 months after the study visit.
Read more about the HARMONIE study at https://rsvharmoniestudy.com/