title: Dissolvable microneedle patches for the delivery of cell-culture-derived influenza vaccine antigens.
abstract: Microneedle patches are gaining increasing attention as an alternative approach for the delivery of vaccines. In this study, a licensed seasonal influenza vaccine from 2007 to 2008 was fabricated into dissolvable microneedles using TheraJect's microneedle technology (VaxMat). The tips of the microneedles were made of antigens mixed with trehalose and sodium carboxymethyl cellulose. The patches containing 15 μg per strain of the influenza antigen were characterized extensively to confirm the stability of the antigen following fabrication into microneedles. The presence of excipients and very low concentrations of the vaccine on the microneedle patches made it challenging to characterize using the conventional single radial immunodiffusion analysis. Novel techniques such as capture enzyme-linked immunosorbent assay and enzyme digestion followed by mass spectroscopy were used to characterize the antigens on the microneedle patches. The in vivo studies in mice upon microneedle administration show immunogenicity against monovalent H1N1 at doses 0.1 and 1 μg and trivalent vaccine at a dose of 1 μg. The initial data from the mouse studies is promising and indicates the potential use of microneedle technology for the delivery of influenza vaccine.
authors.affiliation: Vaccines Research, Novartis Vaccines, Cambridge, Massachusetts, USA. sushma.kommareddy@novartis.com
authors.forename: Sushma
authors.initials: S
authors.lastname: Kommareddy
authors.forename: Barbara C
authors.initials: BC
authors.lastname: Baudner
authors.forename: Seajin
authors.initials: S
authors.lastname: Oh
authors.forename: Sung-yun
authors.initials: SY
authors.lastname: Kwon
authors.forename: Manmohan
authors.initials: M
authors.lastname: Singh
authors.forename: Derek T
authors.initials: DT
authors.lastname: O'Hagan
mesh_terms: D000595:Amino Acid Sequence; D000818:Animals; D000917:Antibody Formation; D000956:Antigens, Viral / Q000737:chemistry / Q000276:immunology*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000737:chemistry / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000737:chemistry / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000737:chemistry / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D051379:Mice; D008807:Mice, Inbred BALB C; D008969:Molecular Sequence Data; D009339:Needles; D014611:Vaccination / Q000295:instrumentation*
chemical_list: D000956:Antigens, Viral; D007252:Influenza Vaccines