Know Cancer

or
forgot password

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


Phase 1
18 Years
46 Years
Not Enrolling
Female
Human Papillomavirus (HPV)

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of a fourth dose of VGX-3100

Outcome Description:

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

Outcome Time Frame:

through Month 6 (end of study)

Safety Issue:

Yes

Principal Investigator

Robert Parker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lyndhurst Gynecologic Associates

Authority:

United States: Food and Drug Administration

Study ID:

HPV-002

NCT ID:

NCT01188850

Start Date:

July 2010

Completion Date:

Related Keywords:

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

Name

Location

Lyndhurst Gynecologic AssociatesWinston-Salem, North Carolina  27103
Laurel Highlands, OB/GYN, P.C.Hopwood, Pennsylvania  15445