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

NCT01188850 | Completed Phase 1

• 1 other identifier: HPV-002
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 3

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of a fourth dose of VGX-3100

  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

  through Month 6 (end of study)

Secondary Outcomes (1)

• Humoral and cellular immune responses to VGX-3100

  through Month 6 (end of study)

Study Arms (1)

6mg of DNA/dose

EXPERIMENTAL

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

Interventions

VGX-3100 BIOLOGICAL

DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

6mg of DNA/dose

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent in accordance with institutional guidelines;
• Successful enrollment in and completion of all study procedures and follow-up in study HPV-001.
• Female 18-46 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 C);
• 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;
• 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 study discharge;
• Able and willing to comply with all study procedures.

You may not qualify if:

• Active infection with herpes simplex virus (HSV);
• Pregnant or breast feeding 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 other than VGX-3100 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.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (3)

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

Laurel Highlands, OB/GYN, P.C.

Hopwood, Pennsylvania, 15904, United States

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

VGX-3100

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 26, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 20, 2011
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

PR (1); US (2)