NCT00685412

Brief 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, 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2008

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

2.7 years

First QC Date

May 22, 2008

Last Update Submit

September 11, 2017

Conditions

Papillomavirus Infections

Keywords

CIN 2 or 3cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of escalating doses of VGX-3100, administered by IM injection with EP to adult female subjects post surgical or ablative treatment of grade 2 or 3 CIN.

    Through Month 4

Secondary Outcomes (1)

  • Humoral and cellular immune responses to VGX-3100 in blood samples obtained from study subjects after each dose of a 3-dose series of VGX-3100 containing 0.6, 2 or 6 mg of DNA/dose.

    At end of study

Study Arms (3)

0.6mg of DNA/dose

EXPERIMENTAL

Subjects will receive a 3 dose series of VGX-3100 containing 0.6mg DNA/dose administered via IM injection + electroporation at Day 0, Month 1 and Month 3

Biological: VGX-3100

2mg of DNA/dose

EXPERIMENTAL

Subjects will receive a 3 dose series of VGX-3100 containing 2mg of DNA/dose administered via IM injection + electroporation at Day 0, Month 1 and Month 3

Biological: VGX-3100

6mg of DNA/dose

EXPERIMENTAL

Subjects will receive a 3 dose series of VGX-3100 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0, Month 1 and Month 3

Biological: VGX-3100

Interventions

VGX-3100BIOLOGICAL

DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

0.6mg of DNA/dose2mg of DNA/dose6mg of DNA/dose

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent in accordance with institutional guidelines;
  • Female 18-45 years of age;
  • Post surgical (including LEEP and conization) or ablative treatment and a diagnosis of CIN 2 or 3, while under physician care as per ASCCP guidelines (Appendix D);
  • Normal ECG and normal laboratory values as judged by Grade 0-1 as per Toxicity Grading Scale for Healthy Adults (Appendix C) for CBC, CPK, SMA-12 and urinalysis evaluations done up to 30 days prior to administration of study treatment;
  • Body mass index (BMI) ≤30 kg/m2;
  • Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) from enrollment to 3 months after the last injection (\~6 months);
  • Able and willing to comply with all study procedures.

You may not qualify if:

  • Active infection with herpes simplex virus (HSV);
  • Positive serological test for HIV virus, hepatitis C virus or Hepatitis B virus surface antigen (HBsAg);
  • Pregnant or breastfeeding subjects;
  • Any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued \> 4 weeks prior to Day 1 of treatment;;
  • Administration of any blood product within 3 months of enrollment;
  • Administration of any vaccine within 6 weeks of enrollment;
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent;
  • Metal implants at the site of injection;
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
  • Any other conditions judged by the investigator that would limit the evaluation of a subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

Laurel Highlands, OB/GYN, P.C.

Hopwood, Pennsylvania, 15445, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Neoplasms

Interventions

VGX-3100

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Christina Chu, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Robert Parker, MD

    Lyndhurst Gynecologic Associates

    PRINCIPAL INVESTIGATOR

  • John Sunyecz, MD

    Laurel Highlands, OB/GYN, P.C.

    PRINCIPAL INVESTIGATOR

  • Javier Morales, MD

    Clinical Research Puerto Rico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

PR(1)US(3)