RSV Vaccine Clinical Trial Launched by Cincinnati Children’s Hospital

An investigational vaccine designed to protect people against respiratory syncytial virus (RSV) has launched a small clinical trial.

This study, being conducted at the Cincinnati Children's Hospital, is important since there is not a specific treatment or vaccine available for RSV.

Anthony S. Fauci, M.D., said in a press release, "A vaccine to prevent the disease from this pervasive and sometimes deadly virus is urgently needed."

This Phase 1 study NCT03473002 will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine called Sendai virus vectored Respiratory Syncytial Virus (SeVRSV) and its ability to induce an immune response.

SeVRSV contains a modified mouse virus (Sendai virus) designed to carry RSV genetic material that will express RSV fusion protein in the vaccine recipient to stimulate RSV-specific antibodies and T-cells.

SeVRSV performed well in previous preclinical and animal studies.

Recent RSV clinical trial news:

• Phase 3 study
• Phase 2 studies
• Phase ½ study 

RSV, a common virus, typically causes mild, cold-like symptoms that resolve within two weeks.

However, the virus can cause severe symptoms, especially among infants and young children.

RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia among children under the age of 1 year. Almost all children in the United States are infected with RSV at least once by the age of 2, and most will experience repeated infections over their lifetimes.

Each year, an estimated 57,000 children under the age of five years are hospitalized in the United States due to RSV infection, according to the Centers for Disease Control and Prevention (CDC).

Additionally, RSV leads to an average of 14,000 deaths among adults older than 65 years, according to the CDC.

Globally, RSV is estimated to cause up to 200,000 deaths annually, according to the World Health Organization.

This vaccine candidate was developed by researchers at St. Jude Children's Research Hospital and manufactured by Children's GMP LLC, of St. Jude Children's Research Hospital in Memphis, Tennessee.

Cincinnati Children's Hospital Medical Center is one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The National Institute of Allergy and Infectious Diseases (NIAID) is part of the National Institutes of Health (NIH).

For more information about this trial go to identifier NCT03473002.

NIAID conducts and supports research--at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.