Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
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ClinicalTrials.gov Identifier: NCT03180684 |
Recruitment Status :
Completed
First Posted : June 8, 2017
Last Update Posted : December 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) Vulvar Dysplasia Vulvar Intraepithelial Neoplasia (VIN) VIN2 VIN3 Pre-cancerous Lesions of the Vulva Human Papillomavirus (HPV) | Biological: VGX-3100 Drug: Imiquimod 5% cream Device: CELLECTRA™ 2000 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva |
Actual Study Start Date : | June 26, 2017 |
Actual Primary Completion Date : | July 23, 2020 |
Actual Study Completion Date : | December 18, 2020 |

Arm | Intervention/treatment |
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Experimental: VGX-3100 + EP
Intramuscular (IM) injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24.
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Biological: VGX-3100
One milliliter (1 mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24. A fifth dose and sixth dose of six mg VGX-3100 may be administered IM with EP per the judgment of the Investigator. Device: CELLECTRA™ 2000 IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 2000 device. |
Experimental: VGX-3100 + EP + Imiquimod
IM injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24. In addition, participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
|
Biological: VGX-3100
One milliliter (1 mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24. A fifth dose and sixth dose of six mg VGX-3100 may be administered IM with EP per the judgment of the Investigator. Drug: Imiquimod 5% cream Participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks. Device: CELLECTRA™ 2000 IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 2000 device. |
- Percentage of Participants with No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples [ Time Frame: At Week 48 ]
- Safety: Percentage of Participants with Adverse Events [ Time Frame: From baseline to Week 100 ]
- Percentage of Participants with No Histologic Evidence of Vulvar HSIL [ Time Frame: At Week 48 ]
- Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples [ Time Frame: At Week 48 ]
- Percentage of Participants with No Evidence of Vulvar HSIL, No Evidence of Vulvar Low Grade Squamous Intraepithelial Lesions (LSIL) (Vulvar Intraepithelial Neoplasia 1 [VIN1]), and No Evidence of Condyloma on Histology [ Time Frame: At Week 48 ]
- Percentage of Participants with No Progression of Vulvar HSIL to Vulvar Cancer [ Time Frame: From baseline to Week 48 ]
- Percent Reduction from Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s) [ Time Frame: From baseline to Weeks 48, 74 and 96 ]
- Change from Baseline in Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations [ Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96 ]
- Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96 ]
- Change from Baseline in Flow Cytometry Response Magnitude [ Time Frame: At baseline and Week 27 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women aged 18 and above;
- Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit;
Exclusion Criteria:
- Biopsy-proven differentiated VIN;
- Any previous treatment for vulvar HSIL within 4 weeks prior to screening;
- Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;
- Pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product;
- Immunosuppression as a result of underlying illness or treatment;
- Significant acute or chronic medical illness.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180684
United States, Delaware | |
Christiana Care Health Systems | |
Newark, Delaware, United States, 19713 | |
United States, Georgia | |
Augusta University | |
Augusta, Georgia, United States, 30912 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Maine | |
Maine Medical Center | |
Scarborough, Maine, United States, 04074 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Mississippi | |
St. Dominic Hospital | |
Jackson, Mississippi, United States, 39216 | |
United States, New Jersey | |
Rutgers New Jersey | |
Newark, New Jersey, United States, 07103 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10461 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Lyndhurst Clinical Research | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Ohio | |
Complete HealthCare for Women, Inc. | |
Columbus, Ohio, United States, 43231 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center - Magee Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Chattanooga's Program in Women's Oncology | |
Chattanooga, Tennessee, United States, 37403 | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-2519 | |
United States, Wisconsin | |
Froedtert and The Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | Jeffrey Skolnik, MD | Inovio Pharmaceuticals |
Responsible Party: | Inovio Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03180684 |
Other Study ID Numbers: |
HPV-201 |
First Posted: | June 8, 2017 Key Record Dates |
Last Update Posted: | December 8, 2021 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
HPV-16 HPV-18 |
Squamous Intraepithelial Lesions of the Cervix Carcinoma, Squamous Cell Carcinoma in Situ Neoplasms Uterine Cervical Dysplasia Precancerous Conditions Uterine Cervical Diseases Uterine Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Interferon Inducers |