Case study: Clare's story: taking part in the HARMONIE study

The HARMONIE study is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR). It is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation, in protecting against one of the leading causes of infant hospitalisation worldwide.

RSV (Respiratory Syncytial Virus) 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 following the easing of COVID-19 public health measures.

“I discussed the research project and any potential risks with the clinical leads at my GP practice, and decided that being part of the research would only benefit my little one,” Clare says, who is taking part in the HARMONIE study at the University of Nottingham Health Service (Cripps Health Centre.)

Participants go through a number of stages from the initial recruitment into the study, to regular monitoring to understand the effect that the immunisation is having. “I had an initial phone call to discuss the study in more detail before registering with an app, followed by a face to face meeting to consent to the study,” Clare explains.

“At this stage, babies are randomly selected to determine whether or not they have the immunisation and follow up checks then take place via the study app.” The study has introduced digital technology including the app to try and make taking part in it easier for participants to integrate into their daily life.

The HARMONIE study aims to recruit more than 20,000 infants across three countries (United Kingdom, France and Germany) and Clare is proud to be taking part. “I think it’s really important to be part of something that may be of significant benefit to children in the future,” she says. 

“I know of a few mums whose children have been admitted to hospital with respiratory illnesses and it is very scary and stressful for the families involved. Knowing that the results of the research could potentially contribute to alleviating or even eradicating this through a simple immunisation shows how important this study is.”

Taking part in research can be a big decision, and Clare encourages all people considering involvement in a study to take the time to get the necessary information first. “Ask lots of questions to understand and weigh up the benefits and risks first to help you come to a decision that you feel comfortable with,” she advises. “All the professionals I have spoken to have been very clear, knowledgeable and helped me to decide for myself whether or not I wanted to take part.”

Find out more about the HARMONIE study at: https://rsvharmoniestudy.com/en-gb