Phase II clinical trial of DNA vaccine for early cervical cancer

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 148

Inclusion Criteria

a. Female subjects age 18-55 years;

b. 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;

c. 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);

d. 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;

e. 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);

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

Exclusion Criteria

a. 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;

b. Pregnancy or breastfeeding;

c. 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;

d. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. GardasilÂ®, CervarixÂ®) are not

excluded);

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

f. Administration of any blood product within 3 months of enrollment;

g. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);

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

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

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

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

l. Active drug or alcohol use or dependence that, in the opinion of the investigator, would

interfere with adherence to study requirements;

m. 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

n. Any other conditions judged by the investigator that would limit the evaluation of a subject.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants with histopathological regression of cervical lesions to CIN 1 or Less as a measure of efficacy. <br/ ><br>Timepoint: 36 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
umber of participants with virologically-proven clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN 1 or less as a secondary measure of efficacy. <br/ ><br>Timepoint: 36 weeks