About

Brief study summary
From 2019 to 2023, we participated in a study to assess whether a new product, called Nirsevimab, protects infants against respiratory syncytial virus (or RSV). Nirsevimab is similar to a product already being used for babies at high risk of severe RSV but requires only one dose to protect babies throughout the entire RSV season. 

Background
RSV is a common virus (germ) that causes respiratory illness (for example, coughing, runny nose) and can be spread by coughing or sneezing or by touching things an infected person has touched. Nearly all children will have an RSV infection at least once by their second birthday. In older children and young adults, RSV usually just causes a mild cold. In infants, especially those less than six months old, RSV infection can cause inflammation of the airways and difficulty breathing, which may require hospitalization. Some children develop wheezing or asthma that may continue for years after the RSV infection is over. 

Severe RSV is more common in Native American communities compared to the rest of the US. One in 10 Native American babies in the Southwest United States will be hospitalized with RSV each year. There is currently no licensed vaccine to prevent RSV in infants. 

Another product called Synagis® was already available at the time of the study to prevent RSV in the first year of life. It is made from antibodies, the parts of our body that fight germs. However, it is only available for babies at high risk of severe RSV illness, including those born too early and those born with heart or lung disease. It also requires five monthly injections. Nirsevimab was developed by the same company that makes Synagis®. Nirsevimab was designed to be stronger and to last longer than Synagis®, so that only one dose is needed to protect babies throughout the RSV season. It was designed to be used to protect healthy babies, as well as babies with a risk factor for severe RSV. 

What we are doing
The MELODY Study was conducted to see if Nirsevimab works to keep babies from getting RSV. A total of 3012 participants were enrolled around the world, including 98 at CIH sites. Following parental informed consent, babies who participated in the study received a shot of either Nirsevimab or saline. They were followed for approximately 18 months to assess any side effects and to see if they were protected from RSV disease. Blood samples were collected four times during follow-up to look at levels of Nirsevimab. If a participant had a respiratory illness, a nasal swab was collected to test for RSV and other germs.

We are currently conducting a study to assess whether a new product, called Nirsevimab, protects infants against Respiratory Syncytial Virus (or RSV). This new product is similar to a product currently used, but requires only one dose to protect babies throughout the entire RSV season.

How this will help improve health in your community
Nirsevimab was found to be safe and effective in protecting babies from RSV disease. Through 150 days after immunization, Nirsevimab was found to be 76.8% effective at preventing hospitalization and 78.6% effective at preventing severe disease.  

Based on the results of the MELODY study and other studies, Nirsevimab was recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) in 2023 for all infants aged <8 months born during or entering their first RSV season and for infants and children aged 8–19 months who are at increased risk of severe RSV disease entering their second RSV season, including American Indian/Alaska Native children. 

Nirsevimab is now available at health facilities in the fall to protect babies during the RSV season. For more information about Nirsevimab for your baby, speak to your healthcare provider. For more information about ways to protect yourself and your family against RSV: https://www.cdc.gov/rsv/index.html

Principal Investigator (PI) or Program Coordinator contact information
Laura Hammitt lhammitt@jhu.edu

Additional information
The primary study results were published in the New England Journal of Medicine in March 2022. The full text of the paper can be found here: https://www.nejm.org/doi/full/10.1056/NEJMoa2110275 

Learn more about the study on clinicaltrials.gov.