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NCT01188850 · ClinicalTrials.gov registry record · Phase 1

Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100

A Phase 1 study, sponsored by Inovio Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01188850 is a Phase 1 study that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 14 participants.

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The verdict

NCT01188850, a Phase 1 study, has completed, sponsored by Inovio Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. The investigators have chosen to deliver our candidate vaccines via electroporation (EP) using the CELLECTRA constant current device to deliver a small electric charge following intramuscular (IM) injection, since animal studies have shown that this delivery method increases the immune response to our DNA vaccine leading to a decrease in the size of tumors caused by HPV 16 and 18. In study HPV-001, the vaccine was given to subjects with a history of CIN 2 and 3 who had been previously treated by surgery. This study is proposed to vaccinate the same subjects with a fourth dose of the VGX-3100 to determine the safety and immune response.

Interventions

  • BIOLOGICAL VGX-3100

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2010-07
Est. Completion 2011-10-20
Phase Phase 1

Sponsor

Inovio Pharmaceuticals

28 total trials

What the Registry Record Tells You About NCT01188850

The ClinicalTrials.gov registry entry for NCT01188850 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inovio Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which VGX-3100 is the first listed.

NCT01188850 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01188850 about?

NCT01188850 is a clinical study titled "Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100". DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines. DNA vaccines appear to be well tolerated in humans. Therefore, the investigators have developed our DNA vaccine,...

What is the current status of trial NCT01188850?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2010-07. Estimated completion is 2011-10-20.

What interventions are being tested in trial NCT01188850?

The interventions under investigation include: VGX-3100 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01188850?

This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.