Clinical trialNCT00685412CompletedPhase 1Interventional

Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3

SponsorInovio PharmaceuticalsEnrollment18Papillomavirus Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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, we have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. We 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. The vaccine is proposed to be given to patients with a history of CIN 2 and 3 that have been treated by surgery. We will determine which dose the DNA vaccine will be the best tolerated and elicit the strongest immune response.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Christina Chu, MD
University of Pennsylvania
Principal Investigator
clinicaltrials.gov ↗
Javier Morales, MD
Clinical Research Puerto Rico
Principal Investigator
clinicaltrials.gov ↗
John Sunyecz, MD
Laurel Highlands, OB/GYN, P.C.
Principal Investigator
clinicaltrials.gov ↗
Robert Parker, MD
Lyndhurst Gynecologic Associates
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Clinical Research Puerto Rico
San Juan, Puerto Rico

United States

Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
Laurel Highlands, Ob/gyn, P.C.
Hopwood, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

VGX-3100

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2008
Primary completion: 31 Jan 2011
Completion: 31 Mar 2011
Last update posted: 13 Sept 2017
Registered enrollment: 18
Registry id: NCT00685412

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.