Evidence map›Paper›PMID 24051434›Full record

ArticleHuman vaccines & immunotherapeutics2013

Tolerability of intramuscular and intradermal delivery by CELLECTRA(®) adaptive constant current electroporation device in healthy volunteers.

Malissa C Diehl, Jessica C Lee, Stephen E Daniels, Pablo Tebas, Amir S Khan, Mary Giffear, Niranjan Y Sardesai, Mark L Bagarazzi

2 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 64 papers.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed
4.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT02163057 phase1 / phase2completednot on this mapstarted 2014, after this paper: background citation

Prospective Study of HPV Specific Immunotherapy in Subjects With HPV Associated Head and Neck Squamous Cell Carcinoma (HNSCCa)

TypeinterventionalSponsorInovio PharmaceuticalsRan2014 to 2017Enrolled22ConditionsHead and Neck Squamous Cell CancerArmsINO-3112, CELLECTRA™-5P
NCT02172911 phase1 / phase2completednot on this mapstarted 2014, after this paper: background citation

Phase I/IIA, Open-Label, Safety, Tolerability, and Immunogenicity Study of INO-3112 Delivered by Electroporation (EP) in Women With Cervical Cancer After Chemoradiation for Newly Diagnosed Disease or Therapy for Recurrent and/or Persistent Disease

TypeinterventionalSponsorInovio PharmaceuticalsRan2014 to 2017Enrolled10ConditionsCervical CancerArmsINO-3112, CELLECTRA™-5P
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 89 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Immunotherapy Targeting HPV16/18 Generates Potent Immune Responses in HPV-Associated Head and Neck Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Review
  11. DNA-based delivery of G-CSF as a durable and efficacious approach to treat severe chronic neutropenia.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
  12. DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Lassa fever vaccine candidates: A scoping review of vaccine clinical trials.Tropical medicine & international health : TM & IH · 2023
    Article
  19. Article
  20. Review

4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Malissa C DiehlInovio Pharmaceuticals; Blue Bell, PA USA.
Jessica C LeeInovio Pharmaceuticals; Blue Bell, PA USA.
Stephen E DanielsPremier Research Group; Austin, TX USA.
Pablo TebasUniversity of Pennsylvania; Division of Infectious Disease; Philadelphia, PA USA.
Amir S KhanInovio Pharmaceuticals; Blue Bell, PA USA.
Mary GiffearInovio Pharmaceuticals; Blue Bell, PA USA.
Niranjan Y SardesaiInovio Pharmaceuticals; Blue Bell, PA USA.
Mark L BagarazziInovio Pharmaceuticals; Blue Bell, PA USA.
Inovio Pharmaceuticals (United States) · USPremier Research Group · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DNA vaccines are being developed as a potentially safe and effective immunization platform. However, translation of DNA vaccines into a clinical setting has produced results that have fallen short of those generated in a preclinical setting. Various strategies are being developed to address this lack of potency, including improvements in delivery methods. Electroporation (EP) creates transient increases in cell membrane permeability, thus enhancing DNA uptake and leading to a more robust immune response. Here, we report on the safety and tolerability of delivering sterile saline via intramuscular (IM) or intradermal (ID) injection followed by in vivo electroporation using the CELLECTRA(®) adaptive constant current device in healthy adults from two open-label studies. Pain, as assessed by VAS, was highest immediately after EP but diminishes by about 50% within 5 min. Mean VAS scores appear to correlate with the amount of energy delivered and depth of needle insertion, especially for intramuscular EP. Mean scores did not exceed 7 out of 10 or 3 out of 10 for IM and ID EP, respectively. The majority of adverse events included mild to moderate injection site reactions that resolved within one day. No deaths or serious adverse events were reported during the course of either study. Overall, injection followed by EP with the CELLECTRA(®) device was well-tolerated and no significant safety concerns were identified. These studies support the further development of electroporation as a vaccine delivery method to enhance immunogenicity, particularly for diseases in which traditional vaccination approaches are ineffective.

Indexed as

AdultElectroporationFemaleHealthy VolunteersHumansInjections, IntradermalInjections, IntramuscularMaleMiddle AgedPainSeverity of Illness IndexVaccinationVaccines, DNAYoung AdultVaccines, DNAelectroporationintradermalintramuscularvaccinationvisual analog scale

Identifiers

PMID24051434
PMCPMC3906411
OpenAlexW2022953507

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.