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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01304524
Registration number
NCT01304524
Ethics application status
Date submitted
16/02/2011
Date registered
25/02/2011
Date last updated
7/09/2018
Titles & IDs
Public title
A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3
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Scientific title
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.
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Secondary ID [1]
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HPV-003
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Universal Trial Number (UTN)
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Trial acronym
HPV-003
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Intraepithelial Neoplasia
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Condition category
Condition code
Cancer
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Cervical (cervix)
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Cancer
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Breast
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - VGX 3100
Other interventions - Placebo
Treatment: Devices - CELLECTRA™-5P
Experimental: VGX 3100 -
Placebo Comparator: Placebo -
Other interventions: VGX 3100
1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
Other interventions: Placebo
1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
Treatment: Devices: CELLECTRA™-5P
CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.
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Assessment method [1]
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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.
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Timepoint [1]
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36 weeks
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Secondary outcome [1]
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Number 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
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Assessment method [1]
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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 and have virologically-proven clearance of HPV16 or HPV18 at the 36 week visit.
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Timepoint [1]
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36 Weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2015
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Sample size
Target
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Accrual to date
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Final
167
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Victoria
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Recruitment postcode(s) [1]
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3052 - Victoria
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Recruitment outside Australia
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San Juan
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Bloemfontein
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South Africa
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Cape Town
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Inovio Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01304524
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Cornelia Trimble, MD
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Address
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Johns Hopkins University
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01304524
Download to PDF