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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: Completed Phase 1 study, sponsored by Inovio Pharmaceuticals.
NCT01188850 is a Phase 1 study that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and tolerability of a fourth dose of VGX-3100, administered by IM injection with EP to adult females who have been previously immunized with three doses of VGX-3100
Interventions
- BIOLOGICAL VGX-3100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-10-20 |
| Phase | Phase 1 |
What the finished NCT01188850 record still lists
NCT01188850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which VGX-3100 is the first listed.
NCT01188850 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01188850's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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