Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2012
Safety and tolerability of the Easy Vax™ clinical epidermal electroporation system in healthy adults.
Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 33 citations in OpenAlex.
- Trial
- Bivalent SARS-CoV-2 spike immunization with non-replicative antibiotic resistance-free DNA vaccine induces immunity to multiple virus variants.Scientific reports · 2025Article
- Tolerability of a piezoelectric microneedle electroporator in human subjects.Bioengineering & translational medicine · 2024Article
- Moderate Heat-Assisted Gene Electrotransfer as a Potential Delivery Approach for Protein Replacement Therapy through the Skin.Pharmaceutics · 2021Article
- Review
- Characterization and preclinical evaluation of the cGMP grade DNA based vaccine, AV-1959D to enter the first-in-human clinical trials.Neurobiology of disease · 2020Review
- Delineating the Cellular Mechanisms Associated with Skin Electroporation.Human gene therapy methods · 2018Article
- Adipose tissue: a new target for electroporation-enhanced DNA vaccines.Gene therapy · 2017Article
- Characterization of guinea pig T cell responses elicited after EP-assisted delivery of DNA vaccines to the skin.Vaccine · 2017Article
- Immunogenicity and safety of xenogeneic vascular endothelial growth factor receptor-2 DNA vaccination in mice and dogs.Oncotarget · 2016Article
- Skin Transfection Patterns and Expression Kinetics of Electroporation-Enhanced Plasmid Delivery Using the CELLECTRA-3P, a Portable Next-Generation Dermal Electroporation Device.Human gene therapy methods · 2015Article
- Skin rejuvenation with non-invasive pulsed electric fields.Scientific reports · 2015Article
- A multi-head intradermal electroporation device allows for tailored and increased dose DNA vaccine delivery to the skin.Human vaccines & immunotherapeutics · 2015Article
- A multi-head intradermal electroporation device allows for tailored and increased dose DNA vaccine delivery to the skin.Human vaccines & immunotherapeutics · 2014Article
- DNA vaccination strategy targets epidermal dendritic cells, initiating their migration and induction of a host immune response.Molecular therapy. Methods & clinical development · 2014Article
- Nanosecond electric pulse effects on gene expression.The Journal of membrane biology · 2013Article
- Tolerability of intramuscular and intradermal delivery by CELLECTRA(®) adaptive constant current electroporation device in healthy volunteers.Human vaccines & immunotherapeutics · 2013Article
- Article
- In vivo molecular imaging and histological analysis of changes induced by electric pulses used for plasmid DNA electrotransfer to the skin: a study in a dorsal window chamber in mice.The Journal of membrane biology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
Abstract
DNA vaccines are cost-effective and versatile, though intracellular delivery has been challenging in humans. Alternative delivery modalities such as electroporation have demonstrated improved immune responses, but are painful. In this single-center, double-blind, medical device trial, we evaluated the safety and tolerability of Easy Vax™ dermal electroporation system, alone (without DNA) in healthy adults. Three randomized protocol doses were administered to 10 subjects (80% white, 60% female, mean age: 32.1 years) in each of two areas (total of six doses). Two subjects complained of shooting pain, burning and/or tingling when doses were administered to the forearm region, but not the lateral deltoid regions. Subsequent doses for the remaining eight subjects were restricted to the deltoid regions only. Tolerability pain scores never exceeded 3 of 10 in the 11-Point Pain Rating scale, and 12 of 100 in the Visual Analog Scale (VAS), and lower in follow-up evaluations (P < 0.0001), with no significant difference between the three dosing protocols. Electrical properties of the skin, measured automatically by the device, showed no correlation between pain intensity and skin conductance. In conclusion, the Easy Vax™ electroporation device is safe and well tolerated when administered over the lateral deltoid skin regions in healthy volunteers.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.