title: Controlled, single-step, stratum corneum disruption as a pretreatment for immunization via a patch.
abstract: A Skin Prep System (SPS) has been developed to provide a well-tolerated and controlled method of stratum corneum disruption using mild abrasion as part of transcutaneous immunization (TCI). In this study, four groups (n=10) of volunteers were pretreated with the SPS using three different lengths of mild abrasive strips (13 mm, 25 mm and 38 mm), or a handheld applicator. They then received a vaccine patch containing 50 microg of the heat-labile enterotoxin from Escherichia coli (LT) at day 0 and day 21. Subsequent anti-LT IgG antibody responses were dependent on abrasive strip length, with highest immune responses seen after use of the longest strip. The development of a simple, single-use, disposable device that is well-tolerated and allows disruption to be modulated represents an important step forward in physical penetration enhancement for the skin.
authors.affiliation: Iomai Corporation, 20 Firstfield Road, Suite 250, Gaithersburg, MD 20878, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Frerichs
authors.forename: Larry R
authors.initials: LR
authors.lastname: Ellingsworth
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Frech
authors.forename: David C
authors.initials: DC
authors.lastname: Flyer
authors.forename: Christina P
authors.initials: CP
authors.lastname: Villar
authors.forename: Jianmei
authors.initials: J
authors.lastname: Yu
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Glenn
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001427:Bacterial Toxins / Q000276:immunology; D004768:Enterotoxins / Q000276:immunology; D004864:Equipment and Supplies; D029968:Escherichia coli Proteins / Q000276:immunology; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D012867:Skin / Q000276:immunology*; D014611:Vaccination / Q000379:methods*; D014612:Vaccines / Q000008:administration & dosage
chemical_list: D000907:Antibodies, Bacterial; D001427:Bacterial Toxins; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D007074:Immunoglobulin G; D014612:Vaccines; C027538:heat-labile enterotoxin, E coli