MedImmune Files IND for Nasally Delivered RSV/PIV-3 Vaccine

MedImmune has filed an investigational new drug (IND) application to begin clinical studies of its respiratory syncytial virus (RSV) and parainfluenza virus Type-3 (PIV-3) candidate vaccine.

Data from preclinical studies indicate that the combination vaccine elicited protective immune responses to RSV and PIV-3, two leading causes of pediatric respiratory disease.

Upon the FDA's review and approval of the IND, MedImmune plans to initiate a Phase I clinical study for the RSV/PIV-3 candidate vaccine. The study will evaluate the safety, tolerability and immunogenicity of the vaccine in healthy adults who have had multiple years of exposure to wild type RSV and PIV-3.

RSV and PIV-3 are viruses that cause serious respiratory disease, particularly in young children, the elderly and immunocompromised individuals. RSV is the most common cause of lower respiratory tract infections in infants and children worldwide, typically occurring during the fall and winter months.