Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100
Public ClinicalTrials.gov record NCT01188850. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I, Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Previously Immunized With VGX-3100
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01188850
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 14 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 46 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Sep 30, 2011
- Completion
- Oct 19, 2011
- Last update posted
- Aug 9, 2018
2010 – 2011
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | 27103 | — |
| Laurel Highlands, OB/GYN, P.C. | Hopwood | Pennsylvania | 15904 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01188850, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01188850 live on ClinicalTrials.gov.