Taking electroporation-based delivery of DNA vaccination into humans: a generic clinical protocol.
We are presently aware of two early-phase DNA vaccine clinical trials in humans using electroporation-enhanced vaccine delivery. Moreover, two phase I immunogenetherapy studies are in progress and several tolerability studies have been performed on healthy volunteers. We have used knowledge from these studies to compose a template for clinical protocols involving electroporation-mediated gene delivery. In this template the emphasis will be on aspects related to electroporation. In addition, we will discuss general topics concerning electroporation-augmented DNA vaccination in human subjects.
Tjelle
Torunn Elisabeth
TE
Inovio AS, Oslo, Norway.
Rabussay
Dietmar
D
Ottensmeier
Christian
C
Mathiesen
Iacob
I
Kjeken
Rune
R
D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D053672:Electrochemotherapy / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007273:Injections, Intramuscular; D010353:Patient Education as Topic; D018579:Patient Selection; D019444:Vaccines, DNA / Q000008:administration & dosage*
D019444:Vaccines, DNA