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NCT03180684 · OUTCOME

Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude

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
MEDIAN
Unit
spot forming units (SFU) per 10^6 cells
Interval / dispersion
Full Range
Time frame
Baseline; Weeks 15, 27, 48, 74, and 96

What was measured

Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood samples. Assessment of cellular immune activity was performed by IFN-γ enzyme-linked immunosorbent spot-forming (ELISpot) assay.

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. 'Number analyzed' indicates the number of participants available for analysis at individual time points.

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 + EP24
VGX-3100 + EP + Imiquimod7

Reported measurements

HPV-16 E6 (Baseline)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP24
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0035.00Not reported
VGX-3100 + EP + Imiquimod1.667Not reported0.008.33Not reported
HPV-16 E6 (Change From Baseline at Week 15)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP0.833Not reported0.0078.33Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.0043.33Not reported
HPV-16 E6 (Change From Baseline at Week 27)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP0.833Not reported0.0058.33Not reported
VGX-3100 + EP + Imiquimod3.333Not reported0.0036.67Not reported
HPV-16 E6 (Change From Baseline at Week 48)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP0.833Not reported0.0056.67Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.003.33Not reported
HPV-16 E6 (Change From Baseline at Week 74)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP15
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0030.00Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.0025.00Not reported
HPV-16 E6 (Change From Baseline at Week 96)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP3
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0038.33Not reported
VGX-3100 + EP + Imiquimod0.833Not reported0.008.33Not reported
HPV-16 E7 (Baseline)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP24
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0015.00Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.001.67Not reported
HPV-16 E7 (Change From Baseline at Week 15)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP3.333Not reported0.0043.33Not reported
VGX-3100 + EP + Imiquimod1.667Not reported0.0056.67Not reported
HPV-16 E7 (Change From Baseline at Week 27)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP3.333Not reported0.0071.67Not reported
VGX-3100 + EP + Imiquimod6.667Not reported0.0040.00Not reported
HPV-16 E7 (Change From Baseline at Week 48)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0031.67Not reported
VGX-3100 + EP + Imiquimod1.667Not reported0.0025.00Not reported
HPV-16 E7 (Change From Baseline at Week 74)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP15
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.00015.00Not reported
VGX-3100 + EP + Imiquimod0.833Not reported0.0021.67Not reported
HPV-16 E7 (Change From Baseline at Week 96)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP3
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP0.000Not reported0.0003.33Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.000.00Not reported
HPV-18 E6 (Baseline)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP24
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP0.000Not reported0.006.67Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.006.67Not reported
HPV-18 E6 (Change From Baseline at Week 15)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP19.167Not reported0.00593.33Not reported
VGX-3100 + EP + Imiquimod10.000Not reported1.67123.33Not reported
HPV-18 E6 (Change From Baseline at Week 27)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP10.833Not reported0.00908.33Not reported
VGX-3100 + EP + Imiquimod5.000Not reported0.00146.67Not reported
HPV-18 E6 (Change From Baseline at Week 48)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP14.167Not reported0.00566.67Not reported
VGX-3100 + EP + Imiquimod3.333Not reported0.0080.00Not reported
HPV-18 E6 (Change From Baseline at Week 74)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP15
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP8.333Not reported0.00925.00Not reported
VGX-3100 + EP + Imiquimod9.167Not reported0.0045.00Not reported
HPV-18 E6 (Change From Baseline at Week 96)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP3
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP20.000Not reported0.0063.33Not reported
VGX-3100 + EP + Imiquimod19.167Not reported1.6748.33Not reported
HPV-18 E7 (Baseline)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP24
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP0.000Not reported0.0011.67Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.003.33Not reported
HPV-18 E7 (Change From Baseline at Week 15)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP2.500Not reported0.0051.67Not reported
VGX-3100 + EP + Imiquimod3.333Not reported0.0016.67Not reported
HPV-18 E7 (Change From Baseline at Week 27)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP22
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0033.33Not reported
VGX-3100 + EP + Imiquimod6.667Not reported0.0043.33Not reported
HPV-18 E7 (Change From Baseline at Week 48)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod7
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0051.67Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.0021.67Not reported
HPV-18 E7 (Change From Baseline at Week 74)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP15
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP1.667Not reported0.0020.00Not reported
VGX-3100 + EP + Imiquimod0.000Not reported0.006.67Not reported
HPV-18 E7 (Change From Baseline at Week 96)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP3
VGX-3100 + EP + Imiquimod4
Values in spot forming units (SFU) per 10^6 cells · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
VGX-3100 + EP3.333Not reported0.005.00Not reported
VGX-3100 + EP + Imiquimod4.167Not reported0.0013.33Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        35.00
        value
        1.667
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        8.33
        value
        1.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E6 (Baseline)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        78.33
        value
        0.833
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        43.33
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E6 (Change From Baseline at Week 15)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        58.33
        value
        0.833
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        36.67
        value
        3.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E6 (Change From Baseline at Week 27)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        56.67
        value
        0.833
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        3.33
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E6 (Change From Baseline at Week 48)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        30.00
        value
        1.667
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        25.00
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    HPV-16 E6 (Change From Baseline at Week 74)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        38.33
        value
        1.667
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        8.33
        value
        0.833
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    HPV-16 E6 (Change From Baseline at Week 96)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        15.00
        value
        1.667
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        1.67
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E7 (Baseline)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        43.33
        value
        3.333
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        56.67
        value
        1.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E7 (Change From Baseline at Week 15)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        71.67
        value
        3.333
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        40.00
        value
        6.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E7 (Change From Baseline at Week 27)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        31.67
        value
        1.667
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        25.00
        value
        1.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    HPV-16 E7 (Change From Baseline at Week 48)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.000
        upper Limit
        15.00
        value
        1.667
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        21.67
        value
        0.833
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    HPV-16 E7 (Change From Baseline at Week 74)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.000
        upper Limit
        3.33
        value
        0.000
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    HPV-16 E7 (Change From Baseline at Week 96)
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood samples. Assessment of cellular immune activity was performed by IFN-γ enzyme-linked immunosorbent spot-forming (ELISpot) assay.
dispersion Type
Full Range
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
MEDIAN
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. 'Number analyzed' indicates the number of participants available for analysis at individual time points.
reporting Status
POSTED
time Frame
Baseline; Weeks 15, 27, 48, 74, and 96
title
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
type
SECONDARY
unit Of Measure
spot forming units (SFU) per 10^6 cells

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice