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Cervical Intraepithelial NeoplasiaPhase 2HPV-003NCT01304524

A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3

A Phase 2 study testing VGX 3100 and CELLECTRA™-5P in people with Cervical Intraepithelial Neoplasia, run by Inovio Pharmaceuticals at 43 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
VGX 3100 and CELLECTRA™-5P
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
167 participants
Where
43 sitesin 9 countries
Study dates
Apr 2011to Apr 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

43 sites in 9 countries.

43 sites in 9 countries

United States27 sites

  • Study site

    Baltimore, Maryland, 21205

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Colton, California, 92324

  • Study site

    Columbus, Ohio, 43231

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    La Mesa, California, 91942

  • Study site

    Lakewood, Colorado, 80228

  • Study site

    Los Angeles, California, 90036

  • Study site

    Missoula, Montana, 59808

  • Study site

    Murray, Utah, 84107

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Oklahoma City, Oklahoma, 73117

  • Study site

    Philadelphia, Pennsylvania, 19122

  • Study site

    Phoenix, Arizona, 85015

  • Study site

    Pleasant Grove, Utah, 84062

  • Study site

    Port Jefferson, New York, 11777

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Renton, Washington, 98055

  • Study site

    Richmond, Virginia, 23233

  • Study site

    Saginaw, Michigan, 48604

  • Study site

    Sandy City, Utah, 84070

  • Study site

    Sarasota, Florida, 34231

  • Study site

    Spokane, Washington, 99207

  • Study site

    The Bronx, New York, 10467

  • Study site

    Tucson, Arizona, 85721

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

India5 sites

  • Study site

    Bangalore, Karnataka, 560017

  • Study site

    Jaipur, Rajasthan, 302017

  • Study site

    Kolkata

  • Study site

    New Delhi

  • Study site

    Pune, 411043

Other trials in India

Canada2 sites

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Vancouver, V5Z-1M9

Other trials in Canada

Estonia2 sites

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

Georgia2 sites

  • Study site

    Batumi, 6400

  • Study site

    Tbilisi

Other trials in Georgia

South Africa2 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Cape Town, 7925

Other trials in South Africa

Australia1 site

  • Study site

    Victoria, 3052

Other trials in Australia

Puerto Rico1 site

  • Study site

    San Juan, 00936

Other trials in Puerto Rico

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

About this study

Official 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.

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.

Being tested
VGX 3100, Placebo, CELLECTRA™-5P
Keywords
CIN 2/3 or CIN 3, Cervical cancer, Papillomavirus
Medical subject headings
Uterine Cervical Dysplasia, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VGX 3100Biological

    1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.

  • PlaceboBiological

    1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.

  • CELLECTRA™-5PDevice

    CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.

Study groups in NCT01304524
Study groupRoleWhat they receive
VGX 3100ExperimentalNot described
Receives: Biological: VGX 3100; Device: CELLECTRA™-5P
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo; Device: CELLECTRA™-5P

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 36 weeks

Secondary outcomes (1)

  1. 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

    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.

    Measured: 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionMay 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01304524
Sponsor's protocol ID
HPV-003
Acronym
HPV-003
Status last verified
Sep 2018
First submitted
16 Feb 2011
Last updated
7 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Bhuyan PK, Dallas M, Kraynyak K, Herring T, Morrow M, Boyer J, Duff S, Kim J, Weiner DB. Durability of response to VGX-3100 treatment of HPV16/18 positive cervical HSIL. Hum Vaccin Immunother. 2021 May 4;17(5):1288-1293. doi: 10.1080/21645515.2020.1823778. Epub 2020 Nov 11.

    PubMed 33175656

  • Trimble CL, Morrow MP, Kraynyak KA, Shen X, Dallas M, Yan J, Edwards L, Parker RL, Denny L, Giffear M, Brown AS, Marcozzi-Pierce K, Shah D, Slager AM, Sylvester AJ, Khan A, Broderick KE, Juba RJ, Herring TA, Boyer J, Lee J, Sardesai NY, Weiner DB, Bagarazzi ML. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015 Nov 21;386(10008):2078-2088. doi: 10.1016/S0140-6736(15)00239-1. Epub 2015 Sep 17.

    PubMed 26386540

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VGX 3100 and CELLECTRA™-5P in people with Cervical Intraepithelial Neoplasia, run by Inovio Pharmaceuticals at 43 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, India, Canada, Estonia, Georgia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy. (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01304524, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.

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