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

Papillomavirus Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685412
• Other study ID #: HPV001
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2008
• Last updated: September 11, 2017
• Start date: May 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2017
• Source: Inovio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Papillomavirus Infections

Intervention

Biological:
• VGX-3100
DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

Locations

Country	Name	City	State
Puerto Rico	Clinical Research Puerto Rico	San Juan
United States	Laurel Highlands, OB/GYN, P.C.	Hopwood	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Inovio Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Through Month 4
Secondary	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.		At end of study