Effectiveness and safety of a Merck RSV prevention drug in infants and children at increased risk for RSV disease

Participants needed: Infants up to 1 year of age born earlier than 30 weeks gestation or with bronchopulmonary dysplasia or heart conditions present since birth

What is the purpose of the study?

This study is testing MK-1654 in infants and children. MK-1654 is being studied to see if it can prevent respiratory syncytial virus (RSV) infection in infants and children at higher risk of having severe RSV illness.

RSV is a common virus that can infect the lungs and air passages, such as the mouth, nose, and throat. Most children who get RSV have a mild cold. However, some children who get RSV may become sicker, such as children born before their expected due date or with certain heart and lung problems. In Nova Scotia, the RSV season normally runs from January to April.

This study will compare MK-1654 to palivizumab. Palivizumab, also called SYNAGIS*, is an approved treatment to prevent severe RSV illness. MK-1654 is not an approved treatment and is considered experimental.

Both MK-1654 and palivizumab are a type of treatment called monoclonal antibodies. These are derived from human-driven antibodies. Antibodies are proteins naturally made in your child’s blood that help their immune system fight illnesses like viral infections. Monoclonal antibodies are proteins made in a lab that act like human antibodies.

Monoclonal antibodies that target RSV work by lowering the amount of the virus in the body. Having a lower amount of RSV in the body means that your child may have a less severe case of RSV if they were to get the infection.

This study is being done to:

• Test the safety of MK-1654 compared to palivizumab
• See how well infants and children tolerate MK-1654 compared to palivizumab
• See how well MK-1654 works compared to palivizumab to prevent lower respiratory infections caused by RSV that require medical attention
• See how well MK-1654 works compared to palivizumab to prevent children from being admitted to the hospital for RSV
• Measure what happens as MK-1654 goes through the body

Who is eligible?

Infants up to 1 year of age who are entering their first RSV season may take part in the study.

Infants must also be considered high-risk for serious RSV infection due to one of the following:
• They were born before their expected due date (at 30 weeks of pregnancy or earlier)
• They have a long-term lung problem related to being born before their expected due date (a disease called bronchopulmonary dysplasia)
• They have a heart condition that was present at birth

There may be reasons why your child cannot be in this study. The study doctor or staff will discuss these with you.

What would I be expected to do?

This study has 2 treatment groups: MK-1654 and palivizumab. The drug your child gets will depend on the group they are put in. A computer will decide which group your child is put in. The study staff will give your child their assigned drug. They will observe your child for at least 30 minutes after your child gets the injection to watch for any immediate side effects. You will then return for a number of follow up visits and additional doses, depending on which group you are in.

The study will take place during 2 RSV seasons. All children will participate in RSV Season 1. Only children who meet specific criteria will participate in RSV Season 2.

Children enrolled for 1 RSV season will be in the study for about 1 year and will visit the study site about 6 to 8 times. Children enrolled for 2 RSV seasons will be in the study for about 18 months and will visit the site about 10 to 12 times. The study staff may ask you to bring your child to the study site for additional visits if needed.

The study will be divided into 2 parts:

Part 1: This part will cover the first 2 months (60 days) of the study. During Part 1, you, your study doctor, and the study staff won’t know which drug your child is getting. In case of a health emergency, the study doctor can find out.
Part 2: This part will start on Day 60 and last through the end of the study. At the Day 60 visit, you, the study doctor, and the study staff will find out which group your child was put in and which drug your child got for their first 2 doses.

Your child will complete the remaining RSV Season 1 visits for their assigned group:

• If your child was assigned to Group 1 (given MK-1654 on Day 1 and placebo on Day 28), they will not get any additional doses of MK-1654 or placebo through the end of RSV Season 1.
• If your child was assigned to Group 2 (given palivizumab on Day 1 and Day 28), they will continue to get monthly doses of palivizumab through the end of RSV Season 1 (for a total of 3 to 5 doses).

If your child is not eligible for RSV Season 2: The study staff will follow your child through 1 year from the date of their first RSV Season 1 dose.

If your child is eligible for RSV Season 2: Up to 4 weeks before the start of RSV Season 2, your child will get 1 dose of MK-1654. The study staff will then follow your child for 6 months from the date of their RSV Season 2 dose.

If interested, please contact Aimee Gonzalez de Armas at ccfv@iwk.nshealth.ca or aimee.gonzalezdarmas@iwk.nshealth.ca