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Tolerability of a piezoelectric microneedle electroporator in human subjects.

作者信息

Lu Chao-Yi, Rohilla Pankaj, Felner Eric I, Byagathvalli Gaurav, Azizoglu Erkan, Bhamla M Saad, Prausnitz Mark R

机构信息

Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, Georgia Institute of Technology Atlanta Georgia USA.

School of Chemical and Biomolecular Engineering, Georgia Institute of Technology Atlanta Georgia USA.

出版信息

Bioeng Transl Med. 2024 Mar 14;9(4):e10662. doi: 10.1002/btm2.10662. eCollection 2024 Jul.


DOI:10.1002/btm2.10662
PMID:39036075
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11256137/
Abstract

Electroporation, or the use of electric pulses to facilitate the intracellular delivery of DNA, RNA, and other molecules, is a well-established technique, that has been demonstrated to significantly augment the immunogenicity of DNA/mRNA vaccines and therapeutics. However, the clinical translation of traditional electroporators has been limited due to high costs, large size, complex user operation, and poor tolerability in humans due to nerve stimulation. In prior work, we introduced ePatch: an ultra-low-cost, handheld, battery-free electroporator employing a piezoelectric pulser coupled with a microneedle electrode array that showed enhanced immunogenic responses to an intradermal SARS-CoV-2 DNA vaccine in mice. The current study shifts focus from efficacy to tolerability, hypothesizing that ePatch's microneedle array, which localizes the electric field to the superficial skin strata, will minimize nerve stimulation and improve patient comfort. We tested this hypothesis in 14 healthy adults, monitoring pain and other potential adverse effects associated with electroporation. Compared to the insertion of a traditional hypodermic needle, the ePatch was less painful. Adverse effects such as pain, tenderness, erythema and swelling at the application sites were minimal, transient, and statistically indistinguishable between the experimental and placebo ePatch application, suggesting excellent tolerability towards electroporation. In summary, ePatch has a favorable tolerability profile in humans and offers the potential for the safe use of electroporation in a variety of clinical settings, including DNA and mRNA vaccination.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/82b1865d5ada/BTM2-9-e10662-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/fd92755ce2f2/BTM2-9-e10662-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/cd855c690f10/BTM2-9-e10662-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/0ed656997f08/BTM2-9-e10662-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/4978d201e88d/BTM2-9-e10662-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/f6704850159d/BTM2-9-e10662-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/82b1865d5ada/BTM2-9-e10662-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/fd92755ce2f2/BTM2-9-e10662-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/cd855c690f10/BTM2-9-e10662-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/0ed656997f08/BTM2-9-e10662-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/4978d201e88d/BTM2-9-e10662-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/f6704850159d/BTM2-9-e10662-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a7b/11256137/82b1865d5ada/BTM2-9-e10662-g001.jpg

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Tolerability of a piezoelectric microneedle electroporator in human subjects.

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引用本文的文献

[1]
Advances in the Functionalization of Vaccine Delivery Systems: Innovative Strategies and Translational Perspectives.

Pharmaceutics. 2025-5-12

[2]
Global research hotspots and trends in DNA vaccine research: A bibliometric and visualization study from 2014 to 2024.

Hum Vaccin Immunother. 2025-12

[3]
Microneedles as a Promising Technology for Disease Monitoring and Drug Delivery: A Review.

ACS Mater Au. 2024-11-28

本文引用的文献

[1]
Gene Therapy for Spinal Muscular Atrophy (SMA): A Review of Current Challenges and Safety Considerations for Onasemnogene Abeparvovec (Zolgensma).

Cureus. 2023-3-15

[2]
Recent Advancements in Electroporation Technologies: From Bench to Clinic.

Annu Rev Biomed Eng. 2023-6-8

[3]
Intratumoral electroporation of a self-amplifying RNA expressing IL-12 induces antitumor effects in mouse models of cancer.

Mol Ther Nucleic Acids. 2022-7-20

[4]
RNA-based therapeutics: an overview and prospectus.

Cell Death Dis. 2022-7-23

[5]
Muscle contractions and pain sensation accompanying high-frequency electroporation pulses.

Sci Rep. 2022-5-16

[6]
RNA therapy: rich history, various applications and unlimited future prospects.

Exp Mol Med. 2022-4

[7]
Clinical progress of nanomedicine-based RNA therapies.

Bioact Mater. 2021-10-22

[8]
Injectable siRNA Approved for Lowering Cholesterol.

JAMA. 2022-3-1

[9]
An ultra-low-cost electroporator with microneedle electrodes (ePatch) for SARS-CoV-2 vaccination.

Proc Natl Acad Sci U S A. 2021-11-9

[10]
COVID-19 Vaccines: Adenoviral Vectors.

Annu Rev Med. 2022-1-27

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