Newcastle Hospitals is asking for volunteers to take part in a study which aims to protect babies from a common respiratory illness.
The study, called HARMONIE, aims to find out if a one-off vaccine, which has already been tested on over 3,000 babies with positive results, reduces hospital admissions due to respiratory syncytial virus (RSV) RSV is a common seasonal virus that infects nearly all babies by their second birthday.
For most, RSV is mild and like a cold, but for others it leads to more severe illness, such as bronchiolitis, requiring hospital admission for oxygen and tube feeding.
Dr Marieke Emonts-le Clercq, consultant paediatrician at Newcastle Hospitals and principal investigator of the study, said:
“Following many years of research, over 3000 babies have received a single-dose RSV vaccine which gives direct protection against the virus. This study will involve a larger group of babies and aims to determine if the vaccine impacts on the number of babies admitted to hospital with RSV.
“We hope that this research will help to reduce the risk of severe illness and that fewer babies will require hospital treatment in the future.”
About the study
The study is enrolling babies who are new-born up to 12 months old, and have been born at more than 29 weeks’ gestational age (the period from conception to birth).
If the study is appropriate for your 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 your baby will receive their routine vaccination injections, and in the other group no injection will be given.
For the babies not receiving the antibody dose, the information you will provide will be extremely useful and vital to the success of the study.
What’s involved
The study lasts for 12 months and involves:
- One visit to the RVI
- Completion of a monthly diary
- A short set of yes/no questions once a month for six months
- A phone call with a member of the RVI team 12 months after your first visit.
Previous smaller studies have shown that the antibody contained in the vaccine works well and protects babies against RSV in one dose.
RSV is one of the leading causes of hospitalisation in all infants worldwide and affects 90% of children before the age of two. In recent months, there has been a resurgence of RSV, thought to be contributed to the easing of Covid-19 public health measures.
How to take part
To take part, please get in touch with the team by calling 0191 282 1564 or emailing Nuth.gnchresearchunit@nhs.net
Further information:
- The study is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).
