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news.MedImmune has filed an investigational new drug application with the FDA to begin clinical studies of its nasally delivered combination vaccine candidate against child respiratory disease.
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Data from preclinical studies indicate that the combination vaccine elicited protective immune responses to respiratory syncytial virus (RSV) and parainfluenza virus type-3 (PIV-3), two leading causes of pediatric respiratory disease.
Upon the FDA’s review and approval of the investigational new drug application (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, while PIV-3 is the leading cause of croup, an acute lower respiratory disease most often observed in young children.
The RSV/PIV-3 candidate vaccine will leverage MedImmune’s novel intranasal vaccine technology. Upon approval, the vaccine would have the potential to provide a new, needle-free option to help protect against two respiratory diseases that are responsible for significant healthcare expenditures annually.