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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00685412
First received: May 22, 2008
Last updated: December 8, 2011
Last verified: December 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

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 ]

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.6mg of DNA/dose
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
DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
Experimental: 2mg of DNA/dose
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
DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
Experimental: 6mg of DNA/dose
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
DNA plasmid delivered via IM injection + 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

Locations
United States, North Carolina
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Laurel Highlands, OB/GYN, P.C.
Hopwood, Pennsylvania, United States, 15445
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00685412     History of Changes
Other Study ID Numbers: HPV001
Study First Received: May 22, 2008
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Inovio Pharmaceuticals:
CIN 2 or 3
cervical cancer

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

ClinicalTrials.gov processed this record on April 22, 2014