MedImmune today announced that it has initiated a Phase 1/2a clinical trial of a live, attenuated intranasal vaccine in healthy children one month to 12 months of age to help prevent severe respiratory syncytial virus (RSV) infections. RSV is the most common respiratory infection in infants and can cause disease in otherwise healthy infants and children.
"RSV is a serious respiratory disease that can have significant effects on children. As a leader in pediatric medicine, MedImmune is committed to developing therapies that can combat the most common cause of pediatric respiratory illness," said Filip Dubovsky, M.D., M.P.H, vice president, clinical development, vaccines. "Because respiratory illness due to RSV occurs in otherwise healthy children, developing a vaccine is a public health priority."
MedImmune is a world leader in the development of innovative therapeutic biologic products for prophylaxis and prevention of infectious diseases. This Phase 1/2a clinical trial is designed to assess the safety, tolerability, immunogenicity and viral shedding of the intranasal RSV vaccine in infants and young children. It is a randomized, double-blind, placebo-controlled and multi-dose study that will enroll 320 children.
The investigational vaccine, MEDI-559, is being developed through a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NAID), part of the National Institutes of Health, to help address RSV disease in children. The vaccine was originally developed in the NAID Division of Intramural Research by a team led by Peter L. Collins, Ph.D. and Brian R. Murphy, M.D.
RSV is the most important cause of viral lower respiratory tract illness in infants worldwide. Each year, an estimated 125,000 infants in the United States are hospitalized with severe RSV infections. RSV is the most common respiratory infection in infancy or childhood that circulates in the Northern Hemisphere predominantly in the fall and winter months. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday.