The investigational new drug (IND) application is for a Phase I safety and immunogenicity study of this influenza vaccine in healthy volunteers. The filing initiates a 30-day review period by the FDA. The FDA may request additional information and clarification before the clinical study can begin.
Leading up to this IND application, DelSite has completed a series of development milestones, including animal toxicology studies, a Phase I safety study of GelVac nasal powder without an antigen and pilot cGMP manufacturing of the vaccine product suitable for clinical studies.
According to the company, the GelVac nasal powder platform combines the advantages of nasal immunization and powder formulation and brings distinct benefits to the vaccine products and patients.
Carlton Turner, CEO of DelSite, said: “I believe the GelVac platform facilitates the beginning of a true paradigm shift away from needles for the delivery of vaccines. The nasal powder formulation needs no preservatives, no adjuvants, no needles and cold storage is not required.”