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Case study: Emily and her son are taking part in the HARMONIE Study to protect him from Respiratory Syncytial Virus

Emily spoke to CRN Kent, Surrey and Sussex about their involvement in the HARMONIE Study.

Emily Taylor, from Surrey, and her baby, Callum are taking part in the HARMONIE Study.

The HARMONIE Study is evaluating the effectiveness of nirsevimab, an antibody immunisation, designed to protect babies against Respiratory Syncytial Virus (RSV). Antibodies in blood are part of the immune system, which helps bodies fight infection and illness.

The antibody dose in the HARMONIE Study acts in the same way as the antibodies within our bodies, but it is targeted specifically to fight RSV. Previous studies have shown this antibody dose to work well, providing direct protection against RSV in one dose. The objective of the HARMONIE Study is to further assess the impact on hospitalisations due to RSV with more babies involved.

“A friend told me about the HARMONIE trial after seeing it on TV news”, explains Emily. “I then went on the trial website to find out more information and sign up. I was then contacted by the trial team who checked whether Callum was eligible to join the trial. He was able to join the trial, so my husband and I signed the consent form.”

Emily continues: “We attended a clinic at St Peter’s Hospital in Chertsey, where Callum was randomly selected to receive the immunisation.”

In the study, babies are randomly assigned into one of two groups. One group will receive the antibody dose by having an injection into their thigh and in the other group, no injection will be given. If a baby is not assigned to receive the antibody dose they will still be followed up in the same way.

Emily is a paediatric doctor and has treated babies with RSV. “In the winter we see a lot of babies with RSV. Some babies are very sick and some are poorly but do not need to come to hospital. I know that if we can find a vaccine for RSV, the number of babies being hospitalised will be reduced. Callum was very little when he was born and I thought if there was a chance he could be protected from RSV, we might as well try.”

Emily continues: “Callum was 11 weeks old when he received the immunisation and it was like his other infant vaccinations, he cried a little bit but there were no side effects afterwards.”

Emily and Callum will be on the HARMONIE Study for one year. Emily continues: “ I now need to complete a diary on an app, which is easy to use, for six months, filling in information about Callum’s health and progress and then we will have a telephone conversation with the study team after 12 months.”