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NCT03180684 · OUTCOME

Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples

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) · Source last updated 2023-08-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 48

What was measured

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.

Analysis population: mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.

Groups in this outcome

VGX-3100 + EP

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.

VGX-3100 + EP + Imiquimod

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod8

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
VGX-3100 + EP15.0Not reported3.237.9Not reported
VGX-3100 + EP + Imiquimod37.5Not reported8.575.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0071
    statistical Comment
    A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.
    statistical Method
    Clopper Pearson
  2. group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    statistical Comment
    1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.
    statistical Method
    Clopper Pearson
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0071
    statistical Comment
    A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.
    statistical Method
    Clopper Pearson
  2. group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    statistical Comment
    1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.
    statistical Method
    Clopper Pearson
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.2
        upper Limit
        37.9
        value
        15.0
      2. group Id
        OG001
        lower Limit
        8.5
        upper Limit
        75.5
        value
        37.5
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      8
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    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.
    id
    OG000
    title
    VGX-3100 + EP
  2. description
    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.
    id
    OG001
    title
    VGX-3100 + EP + Imiquimod
param Type
NUMBER
population Description
mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
reporting Status
POSTED
time Frame
Week 48
title
Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice