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

Primary Purpose

Papillomavirus Infections

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

VGX-3100

About this trial

This is an interventional treatment trial for Papillomavirus Infections focused on measuring CIN 2 or 3, cervical cancer

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Lyndhurst Gynecologic Associates
Laurel Highlands, OB/GYN, P.C.
University of Pennsylvania
Clinical Research Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

0.6mg of DNA/dose

2mg of DNA/dose

6mg of DNA/dose

Arm Description

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

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

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

Outcomes

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.

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.

Full Information

NCT ID

NCT00685412

First Posted

May 22, 2008

Last Updated

September 11, 2017

Sponsor

Inovio Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00685412

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inovio Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papillomavirus Infections

Keywords

CIN 2 or 3, cervical cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.6mg of DNA/dose

Arm Type

Experimental

Arm Description

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

Arm Title

2mg of DNA/dose

Arm Type

Experimental

Arm Description

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

Arm Title

6mg of DNA/dose

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

VGX-3100

Intervention Description

DNA plasmid delivered via IM injection + electroporation using CELLECTRA device

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Chu, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Parker, MD

Organizational Affiliation

Lyndhurst Gynecologic Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Sunyecz, MD

Organizational Affiliation

Laurel Highlands, OB/GYN, P.C.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Javier Morales, MD

Organizational Affiliation

Clinical Research Puerto Rico

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lyndhurst Gynecologic Associates

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Laurel Highlands, OB/GYN, P.C.

City

Hopwood

State/Province

Pennsylvania

ZIP/Postal Code

15445

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Clinical Research Puerto Rico

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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