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Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3
This study is currently recruiting participants.
Verified by VGX Pharmaceuticals, Inc., October 2008
First Received: May 22, 2008   Last Updated: October 15, 2008   History of Changes
Sponsored by: VGX Pharmaceuticals, Inc.
Information provided by: VGX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00685412
  Purpose

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.


Condition Intervention Phase
Papillomavirus Infections
Biological: VGX-3100
Phase I

MedlinePlus related topics: Cancer Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Phase I Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Post Surgical or Ablative Treatment of Grade 2 or 3 Cervical Intraepithelial Neoplasia (CIN)

Further study details as provided by VGX Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Through Month 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: At end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
0.6mg: Experimental
0.6mg DNA/dose
Biological: VGX-3100
DNA plasmid delivered via electroporation using CELLECTRA device
2mg: Experimental
2mg DNA/dose
Biological: VGX-3100
DNA plasmid delivered via electroporation using CELLECTRA device
6mg: Experimental
6mg DNA/dose
Biological: VGX-3100
DNA plasmid delivered via electroporation using CELLECTRA device

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685412

Contacts
Contact: Study Director, MS 267-440-4231

Locations
United States, North Carolina
Lyndhurst Gynecologic Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Tracy Crawford     336-765-7537        
Principal Investigator: Robert L Parker, MD            
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tina Lowther, MD     215-573-3413        
Principal Investigator: Christina Chu, MD            
Sponsors and Collaborators
VGX Pharmaceuticals, Inc.
Investigators
Principal Investigator: Christina Chu, MD University of Pennsylvania
Principal Investigator: Robert Parker, MD Lyndhurst Gynecologic Associates
  More Information

No publications provided

Responsible Party: VGX Pharmaceuticals, Inc ( Chief Medical Officer )
Study ID Numbers: HPV001
Study First Received: May 22, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00685412     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by VGX Pharmaceuticals, Inc.:
CIN 2 or 3
cervical cancer

Study placed in the following topic categories:
Virus Diseases
Carcinoma in Situ
DNA Virus Infections
Papillomavirus Infections
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Virus Diseases
Neoplasms
Neoplasms by Histologic Type
Carcinoma in Situ
Tumor Virus Infections
DNA Virus Infections
Papillomavirus Infections
Infection
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on May 07, 2009