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NCT03180684 · OUTCOME

Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations

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
GEOMETRIC_MEAN
Unit
reciprocal endpoint titer
Interval / dispersion
Standard Deviation
Time frame
Weeks 15, 27, 48, 74, and 96

What was measured

A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.

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 + Imiquimod8

Reported measurements

Anti-HPV-16 (Week 15)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP23
VGX-3100 + EP + Imiquimod8
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP7.33.22Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod13.12.89Not reportedNot reportedNot reported
Anti-HPV-16 (Week 27)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP24
VGX-3100 + EP + Imiquimod8
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP9.63.24Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod15.03.07Not reportedNot reportedNot reported
Anti-HPV-16 (Week 48)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod8
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP15.93.33Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod17.23.06Not reportedNot reportedNot reported
Anti-HPV-16 (Week 74)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP15
VGX-3100 + EP + Imiquimod6
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP14.53.31Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod6.12.80Not reportedNot reportedNot reported
Anti-HPV-16 (Week 96)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP3
VGX-3100 + EP + Imiquimod4
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP37.03.13Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod11.42.85Not reportedNot reportedNot reported
Anti-HPV-18 (Week 15)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP23
VGX-3100 + EP + Imiquimod8
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP24.83.73Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod133.74.32Not reportedNot reportedNot reported
Anti-HPV-18 (Week 27)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP24
VGX-3100 + EP + Imiquimod8
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP44.73.67Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod89.44.85Not reportedNot reportedNot reported
Anti-HPV-18 (Week 48)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP20
VGX-3100 + EP + Imiquimod8
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP69.33.87Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod133.74.36Not reportedNot reportedNot reported
Anti-HPV-18 (Week 74)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP15
VGX-3100 + EP + Imiquimod6
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP83.23.98Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod45.04.23Not reportedNot reportedNot reported
Anti-HPV-18 (Week 96)

Analysis denominator · Participants

GroupSource count
VGX-3100 + EP3
VGX-3100 + EP + Imiquimod4
Values in reciprocal endpoint titer · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VGX-3100 + EP2.91.86Not reportedNot reportedNot reported
VGX-3100 + EP + Imiquimod2.21.61Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.22
        value
        7.3
      2. group Id
        OG001
        spread
        2.89
        value
        13.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Anti-HPV-16 (Week 15)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.24
        value
        9.6
      2. group Id
        OG001
        spread
        3.07
        value
        15.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Anti-HPV-16 (Week 27)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.33
        value
        15.9
      2. group Id
        OG001
        spread
        3.06
        value
        17.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Anti-HPV-16 (Week 48)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.31
        value
        14.5
      2. group Id
        OG001
        spread
        2.80
        value
        6.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Anti-HPV-16 (Week 74)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.13
        value
        37.0
      2. group Id
        OG001
        spread
        2.85
        value
        11.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Anti-HPV-16 (Week 96)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.73
        value
        24.8
      2. group Id
        OG001
        spread
        4.32
        value
        133.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Anti-HPV-18 (Week 15)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.67
        value
        44.7
      2. group Id
        OG001
        spread
        4.85
        value
        89.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Anti-HPV-18 (Week 27)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.87
        value
        69.3
      2. group Id
        OG001
        spread
        4.36
        value
        133.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Anti-HPV-18 (Week 48)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.98
        value
        83.2
      2. group Id
        OG001
        spread
        4.23
        value
        45.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Anti-HPV-18 (Week 74)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.86
        value
        2.9
      2. group Id
        OG001
        spread
        1.61
        value
        2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Anti-HPV-18 (Week 96)
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      8
    units
    Participants
description
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
dispersion Type
Standard Deviation
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
GEOMETRIC_MEAN
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
Weeks 15, 27, 48, 74, and 96
title
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
type
SECONDARY
unit Of Measure
reciprocal endpoint titer

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Preserved source evidence · Not medical advice