A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3
Status: | Completed |
---|---|
Conditions: | Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 9/9/2018 |
Start Date: | April 2011 |
End Date: | April 2015 |
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.
This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA
Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18
associated Cervical intraepithelial neoplasia grade 2/3 or 3.
Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18
associated Cervical intraepithelial neoplasia grade 2/3 or 3.
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
We found this trial at
28
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