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

• ClinicalTrials.gov Identifier: NCT01188850
• Recruitment Status: Completed
• First Posted: August 26, 2010
• Last Update Posted: August 10, 2018
• Sponsor: Inovio Pharmaceuticals
• Information provided by (Responsible Party): Inovio Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Human Papillomavirus (HPV)	Biological: VGX-3100	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I, Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation (EP) in Adult Females Previously Immunized With VGX-3100
• Study Start Date: July 2010
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 20, 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Biological: VGX-3100; DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

Outcome Measures

Primary Outcome Measures :

1. Safety and tolerability of a fourth dose of VGX-3100 [ Time Frame: through Month 6 (end of study) ]
   Safety and tolerability of a fourth dose of VGX-3100, administered by IM injection with EP to adult females who have been previously immunized with three doses of VGX-3100

Secondary Outcome Measures :

1. Humoral and cellular immune responses to VGX-3100 [ Time Frame: through Month 6 (end of study) ]
   Humoral and cellular immune responses to VGX-3100 in blood samples obtained from study subjects after a fourth dose of VGX-3100 (6 mg) in adult female subjects who have been previously vaccinated with a three dose series of VGX-3100 containing 0.6, 2 or 6 mg of DNA/dose.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 46 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

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, 15904

Puerto Rico

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909

Sponsors and Collaborators

Inovio Pharmaceuticals

Investigators

• 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

• Responsible Party: Inovio Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01188850
• Other Study ID Numbers: HPV-002
• First Posted: August 26, 2010
• Last Update Posted: August 10, 2018
• Last Verified: August 2018

Keywords provided by Inovio Pharmaceuticals:

CIN 2 or 3; cervical cancer; Human Papillomavirus (HPV)