A Single-Blind, Randomized, Placebo-Controlled Trial Evaluating the Impact of Clesrovimab on Nasopharyngeal Shedding of RSV and Other Viral and Bacterial Respiratory Pathogens in Infants: The RSV-SHIELD Trial
Respiratory syncytial virus, or RSV, is a common virus that can cause chest infections, breathing trouble, and bronchiolitis in young babies. This study tests a protective injection called clesrovimab (also known as Enflonsia) compared to a harmless salt-water injection (placebo). Researchers want to see if clesrovimab stops RSV from settling in a baby's nose and throat, or clears it faster if they catch it. They will also look at whether the injection affects other common winter bugs, like the flu, common cold viruses, and normal bacteria that live in the nose. Babies taking part will be placed by chance into one of two groups to receive either the medicine or the dummy jab. Doctors will monitor the babies' health, take gentle nose swabs, and track any illnesses, coughs, or hospital visits over the RSV season.
At a glance
What is this study about?
RSV is a very common winter virus that infects almost all children by the age of two. For most babies, it causes nothing more than a runny nose and mild cough. However, for some infants, RSV can move into the lungs, leading to conditions like bronchiolitis or pneumonia. In some cases, babies need extra oxygen or care in hospital to help them breathe.
Clesrovimab (Enflonsia) is an antibody medicine designed to protect babies from severe RSV. Antibodies are proteins that help the body fight off specific germs. Instead of teaching the body to make its own protection like a traditional vaccine, an antibody injection gives immediate, ready-made protection against the virus for several months.
In this study, known as the RSV-SHIELD trial, scientists want to look closely at what happens inside a baby's nose and throat. They want to find out if clesrovimab reduces the amount of virus a baby carries and how quickly their body clears it. They also want to learn if reducing RSV changes the balance of other natural bacteria and viruses living harmlessly in the nose.
By taking part, families help researchers understand how best to shield babies from severe winter chest infections and reduce the need for hospital care during busy winter months.
Key takeaways
- The trial tests clesrovimab (Enflonsia) to see how well it stops RSV in babies.
- Babies receive either one dose of the protective medicine or a dummy salt-water jab.
- Researchers will use gentle nose swabs to check for RSV and other respiratory germs.
- The study also tracks common illnesses like ear infections, chest infections, and hospital visits.
- Taking part is voluntary, and you can withdraw your baby at any time.
Who may be eligible?
This trial is designed specifically for young babies and infants. Both boys and girls can take part. Because RSV is most dangerous to infants during their first winter, the study focuses on protecting babies during this vulnerable stage of life.
To join, parents or legal guardians must be willing and able to bring their baby to study visits, allow study staff to take gentle nose swabs, and keep a simple record of any coughs, colds, or fevers.
Babies who have already received certain RSV treatments or who have specific medical conditions may not be able to take part. The study team will check your baby's medical history thoroughly to ensure that joining the trial is completely safe for them.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- My child is an infant (baby).
- I am the baby's parent or legal guardian and can give consent.
- I am willing to attend scheduled clinic appointments with my baby.
- I am happy for the study team to take gentle nose swabs from my baby.
- I can keep a simple diary of my baby's symptoms if they catch a cold.
What does participation involve?
If you decide to enrol your baby, they will receive a single injection into the muscle (usually the thigh). Babies are placed into one of two groups at random. One group gets the clesrovimab injection, while the other gets a dummy injection containing sterile salt water. As this is a single-blind trial, the study team will know which injection your baby gets, but you will not.
Over the course of the study, you will have regular check-ups with the trial team. During these visits, a nurse will gently swab the inside of your baby's nose to check for RSV and other common germs. These swabs only take a few seconds.
You will be asked to track your baby's health at home, noting down any fevers, runny noses, or coughs. If your baby becomes unwell, the team will examine them and may take extra swabs. Participation lasts through the RSV season, usually over several months, to see how long protection lasts.
Potential risks and benefits
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Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It is a common bug that causes colds and coughs, but it can make breathing difficult for young infants.
Is clesrovimab a vaccine?
Not quite. Vaccines teach the immune system to make its own shields over time. Clesrovimab provides ready-made antibodies that give immediate, temporary protection.
Will the nose swabs hurt my baby?
No, but they can feel a little tickly or uncomfortable for a few seconds. Nurses are very experienced at taking them quickly and gently.
Can my baby still have their normal routine immunisations?
Yes. Taking part should not interfere with your baby's standard NHS childhood immunisation schedule, but the study team will review this with you.
What happens if my baby gets sick during the study?
You will have a direct contact number for the trial team. They will assess your baby and ensure they receive the right medical care promptly.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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