title: Phase 1 clinical study with Bioneedles, a delivery platform for biopharmaceuticals.
abstract: Vaccination campaigns using syringes, needles, vials and refrigeration have a heavy logistic burden. A vaccination platform that circumvents these problems would improve the quality of vaccination campaigns by faster and safer vaccination of populations anywhere. A clinical phase I study in eighteen volunteers has been carried out, using biodegradable mini-implants (Bioneedles™), made of a polymer based on starch, allowing for high speed vaccination of thermostable vaccines and omitting the use of syringes, needles, vials and refrigeration. Clinical and histological assessment demonstrated excellent local tissue tolerance for the Bioneedle polymer. Histological findings were those of normal tissue restitution without evidence for infection, allergic or granulomatous response, or scar formation. The Bioneedle polymer was mostly degraded within hours, remnants of it being cleared by macrophages. The technique of subcutaneous insertion of Bioneedles with a kinetic energy of 0.33 Joule and higher is 100% effective and pain free. All volunteers graded global tolerance of Bioneedles as "very good" or "good". Bioneedles offer a safe, effective and very fast alternative vaccination platform.
authors.affiliation: Bioneedle Group, Landgraaf, The Netherlands. Electronic address: gijsbertusgp@home.nl.
authors.forename: Gijsbertus G P
authors.initials: GG
authors.lastname: van de Wijdeven
authors.affiliation: Den Dolder, The Netherlands. Electronic address: Hirschberghoang@gmail.com.
authors.forename: Hoang J H B
authors.initials: HJ
authors.lastname: Hirschberg
authors.affiliation: Center for Dermatopathology, Freiburg, Germany. Electronic address: labor@zdpf.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Weyers
authors.affiliation: Dermatopharmacological Center, Freiburg, Germany. Electronic address: schalla@derma.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schalla
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D001702:Biopharmaceutics / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D009339:Needles; D011108:Polymers / Q000008:administration & dosage; D013594:Syringes; D014611:Vaccination / Q000379:methods; D014612:Vaccines / Q000008:administration & dosage*
chemical_list: D011108:Polymers; D014612:Vaccines
keywords: Bioneedle; Biopharmaceutical; Clinical trial; Delivery platform; Polymer; Starch