Method and apparatus for the delivery of plynucleotide vaccines to mammalia skin

Abstract

An object of the invention is to provide a method and apparatus for the delivery of polynucleotide vaccines into mammalian skin cells to increase T cell response and reduce pain and discomfort due to long electric waveform application and due to muscle contractions. The method includes administering a polynucleotide vaccine into the skin at an administration site, (b) applying a needle electrode to the skin in the vicinity to the administration site, and (c) applying a sequence of at least three single, operator-controlled, independently programmed, narrow interval electrical waveforms, which have pulse intervals that are less than 100 milliseconds, to deliver the 15 polynucleotide vaccine into the skin cells by electroporation.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority based upon copending U.S. Provisional Application Ser. No. 60 / 924,968, filed 21 May 2007.TECHNICAL FIELD[0002]The present invention relates generally to methods and apparatus for the delivery of polynucleotide vaccines into mammalian skin cells. More specifically, the present invention provides methods and apparatus for the delivery of polynucleotide vaccines into mammalian skin cells using electrical waveforms and electroporation.BACKGROUND ART[0003]For purposes of the present disclosure, the term “pulse interval” means the time from the beginning of one pulse to the beginning of the next pulse.[0004]The following publications are discussed hereinbelow:[0005]U.S. Pat. No. 6,010,613;[0006]U.S. Pat. No. 6,603,998;[0007]U.S. Pat. No. 6,713,291;[0008]“Enhancement of Cellular Immune Response to a Prostate Cancer DNA Vaccine by Intradermal Electroporation”, by Roos et al, Molecular Therapy, Vol. 13, No. 2, Febru...

AI Technical Summary

Benefits of technology

This approach allows for the rapid administration of polynucleotide vaccines in less than 3.5 seconds with minimal muscle discomfort, achieving equivalent or superior genetic expression and T-cell responses compared to traditional wide interval waveforms, while ensuring successful protein secretion.

Problems solved by technology

Aside from the beneficial results disclosed in the Roos et al publication, there are two undesirable results observed by using the slow PulseAgile electrical waveforms.

The first undesirable result is that each slow PulseAgile electrical waveform administration protocol took approximately 3.5 seconds.

The second undesirable result disclosed in Roos et al is that each slow PulseAgile electrical waveform causes a perceptible muscle contraction.

The muscle contraction itself can also cause discomfort or pain.

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