title: Development of a nasal adenovirus-based vaccine: Effect of concentration and formulation on adenovirus stability and infectious titer during actuation from two delivery devices.
abstract: A nasal adenovirus-based vaccine is under development. To determine if aggregation occurs during vaccination, infectious titer (limiting dilution) and capsid integrity (dynamic light scattering) were assessed after extrusion of a model vector from two intranasal delivery devices. Preparations of 2.5x10(12) and 1.25x10(11) virus particles (vp)/ml were studied. Virus aggregated ( approximately 10%) in the multi-dose vessel. Virus titer dropped by one log. Virus in the unit-dose device aggregated ( approximately 1%). Titer remained unchanged. Aggregation was concentration dependent. Formulations prevented aggregation during actuation, freeze-thaw and long-term storage. The device, formulation and dose may significantly influence aggregation and potency of any nasal adenovirus 5-based vaccine.
authors.affiliation: Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, USA.
authors.forename: Sandra S
authors.initials: SS
authors.lastname: Renteria
authors.forename: Courtney C
authors.initials: CC
authors.lastname: Clemens
authors.forename: Maria A
authors.initials: MA
authors.lastname: Croyle
mesh_terms: D000256:Adenoviridae / Q000276:immunology; D000281:Administration, Intranasal; D002460:Cell Line; D004304:Dosage Forms; D004339:Drug Compounding; D016503:Drug Delivery Systems; D006801:Humans; D014765:Viral Vaccines / Q000096:biosynthesis*; D014771:Virion
chemical_list: D004304:Dosage Forms; D014765:Viral Vaccines