Serum Institute signs licensing agreement to commercialize St. Jude vaccine against RSV

St. Jude Children's Research Hospital and the Serum Institute of India have signed a licensing agreement to complete development and commercialization of a St. Jude vaccine against the respiratory syncytial virus (RSV), the virus that causes croup and lower respiratory infections. RSV kills about 160,000 people, primarily infants, worldwide each year. There are currently no approved vaccines.

The agreement gives Serum Institute of India the right to design and conduct clinical trials of the patented St. Jude vaccine, known as SeVRSV.

"RSV remains a serious threat to infants worldwide during their first year of life and to anyone, including pediatric cancer patients, whose immune response has been weakened by illness or age," said James R. Downing, M.D., St. Jude president and chief executive officer. "We are pleased that Serum's staff and leadership have recognized the life-saving potential of this vaccine. We look forward to working closely with them to make this vaccine accessible around the globe."

RSV is the most common cause of lower respiratory infections in infants and children. Researchers have estimated that each year 34 million children younger than 5 years old are infected with RSV and that 10 percent require hospitalization. RSV treatment costs are estimated to be more than $400 million annually in the U.S. alone.

The St. Jude vaccine uses a mouse parainfluenza virus type 1 modified to carry an RSV gene and prime the human immune response. The mouse virus looks similar to the human parainfluenza virus type 1, which is the most common cause of croup in children. St. Jude researchers capitalized on that similarity in the SeVRSV vaccine to use the mouse virus to ready the human immune response and protect against serious illness from both RSV and croup.

The SeVRSV vaccine is one of about 60 RSV candidate vaccines in development worldwide, including 16 that are in clinical trials. In preclinical tests, SeVRSV proved safe and effective. SeVRSV is designed to be administered to infants via nasal droplets.