title: Transcutaneous delivery and thermostability of a dry trivalent inactivated influenza vaccine patch.
abstract: A patch containing a trivalent inactivated influenza vaccine (TIV) was prepared in a dried, stabilized formulation for transcutaneous delivery. When used in a guinea pig immunogenicity model, the dry patch was as effective as a wet TIV patch in inducing serum anti-influenza IgG antibodies. When the dry TIV patch was administered with LT as an adjuvant, a robust immune response was obtained that was comparable with or better than an injected TIV vaccine. When stored sealed in a nitrogen-purged foil, the dry TIV patch was stable for 12 months, as measured by HA content, under both refrigerated and room temperature conditions. Moreover, the immunological potency of the vaccine product was not affected by long-term storage. The dry TIV patch was also thermostable against three cycles of alternating low-to-high temperatures of -20/25 and -20/40 degrees C, and under short-term temperature stress conditions. These studies indicate that the dry TIV patch product can tolerate unexpected environmental stresses that may be encountered during shipping and distribution. Because of its effectiveness in vaccine delivery and its superior thermostable characteristics, the dry TIV patch represents a major advance for needle-free influenza vaccination.
authors.affiliation: Iomai Corporation, Gaithersburg, MD 20878, USA. vfrolov@iomai.com
authors.forename: Vladimir G
authors.initials: VG
authors.lastname: Frolov
authors.forename: Robert C
authors.initials: RC
authors.lastname: Seid
authors.forename: Olabisi
authors.initials: O
authors.lastname: Odutayo
authors.forename: Mohammad
authors.initials: M
authors.lastname: Al-Khalili
authors.forename: Jianmei
authors.initials: J
authors.lastname: Yu
authors.forename: Olga Y
authors.initials: OY
authors.lastname: Frolova
authors.forename: Hong
authors.initials: H
authors.lastname: Vu
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Butler
authors.forename: Jee Loon
authors.initials: JL
authors.lastname: Look
authors.forename: Larry R
authors.initials: LR
authors.lastname: Ellingsworth
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Glenn
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology; D000279:Administration, Cutaneous; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D001427:Bacterial Toxins / Q000008:administration & dosage / Q000494:pharmacology; D003890:Desiccation; D004304:Dosage Forms; D004355:Drug Stability; D004356:Drug Storage; D004768:Enterotoxins / Q000008:administration & dosage / Q000494:pharmacology; D029968:Escherichia coli Proteins / Q000008:administration & dosage / Q000494:pharmacology; D005260:Female; D006168:Guinea Pigs; D007074:Immunoglobulin G / Q000097:blood; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D015164:Vaccines, Inactivated / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D001427:Bacterial Toxins; D004304:Dosage Forms; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D007074:Immunoglobulin G; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; C027538:heat-labile enterotoxin, E coli