Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100

NCT ID: NCT01188850

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-10-20

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, 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.

Conditions

Human Papillomavirus (HPV)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6mg of DNA/dose

Subjects who have previously received a 3 dose series of VGX-3100 containing either 0.6, 2 or 6mg DNA/dose will receive a fourth dose of VGX-3100 containing 6mg of DNA/dose administered via IM injection + electroporation at Day 0

Group Type: EXPERIMENTAL

VGX-3100

Intervention Type: BIOLOGICAL

DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

Interventions

VGX-3100

DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Written informed consent in accordance with institutional guidelines;

2. Successful enrollment in and completion of all study procedures and follow-up in study HPV-001.

3. Female 18-46 years of age;

4. 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 C);

5. Normal ECG and CPK, as judged by Grade 0-1 as per Toxicity Grading Scale for Healthy Adults (Appendix B) done up to 30 days prior to administration of study treatment;

6. Body mass index (BMI) ≤30 kg/m2;

7. 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 study discharge;

8. Able and willing to comply with all study procedures.

Exclusion Criteria

1. Active infection with herpes simplex virus (HSV);

2. Pregnant or breast feeding subjects;

3. 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;

4. Administration of any blood product within 3 months of enrollment;

5. Administration of any vaccine within 6 weeks of enrollment;

6. Patient is currently participating or has participated in a study with an investigational compound or device other than VGX-3100 within 30 days of signing informed consent;

7. Metal implants at the site of injection;

8. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;

9. 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;

10. Any other conditions judged by the investigator that would limit the evaluation of a subject.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inovio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Parker, MD

Role: PRINCIPAL_INVESTIGATOR

Lyndhurst Gynecologic Associates

John Sunyecz, MD

Role: PRINCIPAL_INVESTIGATOR

Laurel Highlands, OB/GYN, P.C.

Javier Morales, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Puerto Rico

Locations

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, United States

Laurel Highlands, OB/GYN, P.C.

Hopwood, Pennsylvania, United States

Clinical Research Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

HPV-002

Identifier Type: -

Identifier Source: org_study_id