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VGX-3100 · 6 trials · 12 indications
Baseline biomarker-positive participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at Week 36, and participants who did not have unscheduled excision or biopsy sample obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep™. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. The first tissue removal sample within the time frame determines the histology endpoint.
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
A treatment responder for the primary endpoint was defined as a participant with no histologic evidence of vulvar HSIL (normal tissue or vulvar low grade squamous intraepithelial lesions (LSIL) \[vulval intraepithelial neoplasia 1 (VIN1)\] or condyloma) and no evidence of HPV-16 or HPV-18 (i.e., elimination of the specific genotypes \[16, 18, or both\]) in vulvar tissue at evaluation and who did not receive any non-study related treatment for vulvar HSIL. All lesions were evaluated for histologic evidence of vulvar HSIL or evidence of HPV-16/18 in vulvar tissue.
Safety and tolerability of a fourth dose of VGX-3100, administered by IM injection with EP to adult females who have been previously immunized with three doses of VGX-3100
| Arm | Type | Description |
|---|---|---|
| VGX-3100 + EP | EXPERIMENTAL | Participants received 3 IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| Matched Placebo + EP | PLACEBO_COMPARATOR | Participants received 3 IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| Placebo + EP | PLACEBO_COMPARATOR | Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12. |
| VGX-3100 | EXPERIMENTAL | Adult participants who were HIV negative with histologically confirmed anal or anal/peri-anal HSIL associated with HPV-16 and/or 18, received four 6 mg doses of VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 40 followed immediately by EP using the CELLECTRA™ 5PSP device. |
| VGX-3100 + EP + Imiquimod | EXPERIMENTAL | Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks. |
| 6mg of DNA/dose | EXPERIMENTAL | Subjects who have previously received a 3 dose series of VGX-3100 containing either 0.6, 2 or 6mg DNA/dose will receive a fourth dose of VGX-3100 containing 6mg of DNA/dose administered via IM injection + electroporation at Day 0 |
| 0.6mg of DNA/dose | EXPERIMENTAL | Subjects will receive a 3 dose series of VGX-3100 containing 0.6mg DNA/dose administered via IM injection + electroporation at Day 0, Month 1 and Month 3 |
| 2mg of DNA/dose | EXPERIMENTAL | Subjects will receive a 3 dose series of VGX-3100 containing 2mg of DNA/dose administered via IM injection + electroporation at Day 0, Month 1 and Month 3 |
| Name | Type | Description |
|---|---|---|
| VGX-3100 | BIOLOGICAL | 1 milliliter (mL) VGX-3100 injected IM. |
| Matched Placebo | BIOLOGICAL | 1 mL of matched Placebo injected IM. |
| CELLECTRA™-5PSP | DEVICE | CELLECTRA™-5PSP used for EP following IM injection of VGX 3100. |
| Placebo | BIOLOGICAL | 1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. |
| Electroporation (EP) | DEVICE | Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device. |
| CELLECTRA™ 5PSP | DEVICE | IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 5PSP device. |
| Imiquimod 5% Cream | DRUG | Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks. |
| CELLECTRA™ 2000 | DEVICE | IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device. |
Inclusion Criteria: * Women aged 18 years and above * Confirmed cervical infection with HPV types 16 and/or 18 at screening * Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first...