Safety and Efficacy Trial of MK-1654 to prevent Respiratory Syncytial Virus in Healthy Infants

A phase 2b/3 double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants

Status: In Follow-Up 

Population: Paediatric  

Disease group: RSV

Funder: MSD

Sponsor: Merck Sharp & Dohme Corp.

Principal Investigator: Dr. Eva Galiza

Study Aims

This trial is testing an experimental drug called MK-1654 in infants. MK-1654 is a type of antibody (called a “monoclonal antibody”) being studied to see if it can prevent illnesses caused by respiratory syncytial virus (RSV). An antibody is a protein naturally made in your child’s blood that helps their immune system fight illnesses like viral infections. 

RSV is a common respiratory virus. It can cause cold-like symptoms, such as a runny nose, fever and cough. Both adults and children can get RSV. Most healthy adults recover quickly from the virus. Sometimes, RSV causes serious health issues in infants, such as breathing problems, high
fever, and infections of the lungs. RSV is one of the most common reasons that Infants are taken to hospital and is the leading cause of hospitalisation and infant death under six months of age worldwide. 

Currently, there are no treatments available in the UK to prevent RSV in healthy infants. MK-1654 has not been approved for use in the UK and is not available by prescription. However, it is similar to an approved drug called palivizumab which is used to prevent RSV in infants with certain medical conditions. 

What does participating in the study involve?

If you decide for your child to participate in this trial, you will be invited for a clinic visit. During this visit, the trial doctor will check if it is safe, and if it is possible for your child to take part in this trial. 

A computer will decide which group your child is put in. Your child has a 2 in 3 chance of getting   MK-1654, and a 1 in 3 chance of getting placebo. Your child’s vital signs (including heart rate, temperature, breathing rate and oxygen saturation level) will be checked.  

You, the trial doctor, and the trial staff won’t know if your child was given MK-1654 or placebo. In case of a health emergency, they can find out. Some infants will be in this trial for about 12 months and visit the trial site about 7 times. Others will be in the trial for about 18 months and visit the trial site about 8 times. Some infants will have a maximum of 3 blood draws in the trial and others will have 5 blood draws depending on when they start the trial. Additional blood draw of 1.2ml may be required for safety checks if your child has a hypersensitivity reaction to the injection. A swab may be taken from your child’s nose if they have any chest infection symptoms. Most visits will last about 1 – 2 hours.  

Your child’s GP will be informed if your child takes part in this trial. 

The trial team will contact you by telephone about once a week to check on your child’s health. You will need to fill in the eDiary every day for about 6 weeks after your child receives the trial injection. You will be given a card that identifies your child as a participant taking part in this trial. You should carry it with you at all times. 

For more information about the study please contact the trial email: rsvstudy@sgul.ac.uk