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NCT03051516 · OUTCOME

HPV Antibody Level

HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Source last updated 2024-02-28

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to month 36

What was measured

Will evaluate placebo and vaccine recipients separately. Will assess whether presence and amount of HPV antibody, detected at baseline in the placebo arm, is protective against recurrence. For the vaccine arm, will assess whether magnitude of vaccine antibody levels month 1 following the third vaccination in the vaccine arm affects recurrence.

Analysis population: Participants with usable serology samples from at least one timepoint are included in this analysis.

Groups in this outcome

Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM

Arm II (Placebo)

Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)68
Arm II (Placebo)80

Reported measurements

HPV16

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)33Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)49Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)22Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)13Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)8Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)12Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)5Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)6Not reportedNot reportedNot reportedNot reported
HPV18

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)32Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)48Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)23Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)14Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)7Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)12Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)6Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)6Not reportedNot reportedNot reportedNot reported
HPV31

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)28Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)48Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)27Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)14Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)8Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)13Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)5Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)5Not reportedNot reportedNot reportedNot reported
HPV33

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)30Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)47Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)25Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)15Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)8Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)15Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)5Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)3Not reportedNot reportedNot reportedNot reported
HPV45

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)33Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)41Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)22Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)21Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)8Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)16Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)5Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)2Not reportedNot reportedNot reportedNot reported
HPV52

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)27Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)42Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)28Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)20Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)7Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)14Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)6Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)4Not reportedNot reportedNot reportedNot reported
HPV58

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)28Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)44Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)27Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)18Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)7Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)13Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)6Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)5Not reportedNot reportedNot reportedNot reported
Any HPV

Negative, No event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)16Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)20Not reportedNot reportedNot reportedNot reported

Positive, no event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)39Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)42Not reportedNot reportedNot reportedNot reported

Negative, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)4Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)6Not reportedNot reportedNot reportedNot reported

Positive, HSIL

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)9Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)12Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.93
    statistical Method
    Log Rank
  2. group Description
    This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.77
    statistical Method
    Log Rank
  3. group Description
    This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.57
    statistical Method
    Log Rank
  4. group Description
    This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.73
    statistical Method
    Log Rank
  5. group Description
    This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.998
    statistical Method
    Log Rank
  6. group Description
    This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.93
    statistical Method
    Log Rank
  7. group Description
    This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.95
    statistical Method
    Log Rank
  8. group Description
    This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.91
    statistical Method
    Log Rank
  9. group Description
    This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.22
    statistical Method
    Log Rank
  10. group Description
    This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.27
    statistical Method
    Log Rank
  11. group Description
    This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.72
    statistical Method
    Log Rank
  12. group Description
    This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.71
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.93
    statistical Method
    Log Rank
  2. group Description
    This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.77
    statistical Method
    Log Rank
  3. group Description
    This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.57
    statistical Method
    Log Rank
  4. group Description
    This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.73
    statistical Method
    Log Rank
  5. group Description
    This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.998
    statistical Method
    Log Rank
  6. group Description
    This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.93
    statistical Method
    Log Rank
  7. group Description
    This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.95
    statistical Method
    Log Rank
  8. group Description
    This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.91
    statistical Method
    Log Rank
  9. group Description
    This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.22
    statistical Method
    Log Rank
  10. group Description
    This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.27
    statistical Method
    Log Rank
  11. group Description
    This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.72
    statistical Method
    Log Rank
  12. group Description
    This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.71
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        49
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        13
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        12
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      title
      Positive, HSIL
    title
    HPV16
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        48
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        14
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        12
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      title
      Positive, HSIL
    title
    HPV18
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        48
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        14
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      title
      Positive, HSIL
    title
    HPV31
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        47
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        15
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        15
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      title
      Positive, HSIL
    title
    HPV33
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        41
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        21
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        16
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      title
      Positive, HSIL
    title
    HPV45
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        42
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        20
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        14
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      title
      Positive, HSIL
    title
    HPV52
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        44
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        18
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        13
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      title
      Positive, HSIL
    title
    HPV58
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        20
      title
      Negative, No event
    2. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        42
      title
      Positive, no event
    3. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      title
      Negative, HSIL
    4. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        12
      title
      Positive, HSIL
    title
    Any HPV
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      80
    units
    Participants
description
Will evaluate placebo and vaccine recipients separately. Will assess whether presence and amount of HPV antibody, detected at baseline in the placebo arm, is protective against recurrence. For the vaccine arm, will assess whether magnitude of vaccine antibody levels month 1 following the third vaccination in the vaccine arm affects recurrence.
groups
  1. description
    Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
    id
    OG000
    title
    Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
  2. description
    Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
    id
    OG001
    title
    Arm II (Placebo)
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants with usable serology samples from at least one timepoint are included in this analysis.
reporting Status
POSTED
time Frame
Up to month 36
title
HPV Antibody Level
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice