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Phase II Placebo Controlled Study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) Delivered IM Followed by Electroporation With Cellectra-5P for the Treatment of Biopsy-proven CIN 2/3 or CIN 3 With Documented HPV 16 or 18.


Phase 2
18 Years
55 Years
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia

Thank you

Trial Information

Phase II Placebo Controlled Study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) Delivered IM Followed by Electroporation With Cellectra-5P for the Treatment of Biopsy-proven CIN 2/3 or CIN 3 With Documented HPV 16 or 18.


Inclusion Criteria:



- Female subjects age 18-55 years;

- Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue
collected less than 10 weeks prior to Vaccination/EP #1 with no evidence of invasive
cancer in any specimen;

- Colposcopy is satisfactory based on visualization of the entire squamocolumnar
junction and the upper limit of the entire aceto-white or suspected CIN disease area;
lesions in ≤ 3 cervical quadrants (4 quadrant disease where the lesion occupies less
than 50% of each quadrant will be considered for inclusion);

- Healthy subjects as judged by the Investigator based on medical history, PE, and
normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4
weeks prior to enrollment and administration of study drug;

- Women of child-bearing potential agree to remain sexually abstinent, use two
medically effective methods of contraception (e.g. oral contraception, barrier
methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile
(i.e., vasectomy) through 36 weeks (9 months);

- Able and willing to comply with all study procedures and voluntarily signs informed
consent form

Exclusion Criteria:

- Unsatisfactory colposcopy defined as incomplete visualization of the entire
squamocolumnar junction and the upper limit of the entire aceto-white or suspected
CIN disease area;

- Pregnancy or breastfeeding

- Immunosuppression including any concurrent condition requiring the continued use of
systemic or topical steroids at or near the injection site [deltoid, upper arm]
(excluding inhaled and eye drop-containing corticosteroids) or the use of
immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks
prior to Day 0 of study vaccine administration; autoimmune disorders, transplant
recipients;

- History of previous therapeutic HPV vaccination (individuals who have been immunized
with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not
excluded);

- Positive serological test for hepatitis C virus or hepatitis B virus surface
antigen(HBsAg) or human immunodeficiency virus (HIV)

- Administration of any blood product within 3 months of enrollment

- Administration of any licensed vaccine within 2 weeks of enrollment( 4weeks for
measles vaccine)

- Participation in a study with an investigational compound or device within 30 days of
signing informed consent;

- Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);

- History of seizures (unless seizure free for 5 years);

- Tattoos, scars, or active lesions/rashes within 2 cm of the intended site of
vaccination/EP or any implantable leads; or any implantable leads;

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.

Outcome Description:

The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit.

Outcome Time Frame:

36 weeks

Safety Issue:

No

Principal Investigator

Cornelia Trimble, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

HPV-003

NCT ID:

NCT01304524

Start Date:

April 2011

Completion Date:

March 2014

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • CIN 2/3 or CIN 3
  • Cervical cancer
  • Papillomavirus
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Uterine Cervical Dysplasia
  • Carcinoma in Situ

Name

Location

Great Falls, Montana  59405
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Denver, Colorado  
Baltimore, Maryland  21287
Charlotte, North Carolina  
Eugene, Oregon  
Charleston, South Carolina  
Tulsa, Oklahoma  
Salt Lake City, Utah  84112