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NCT03051516 · OUTCOME

Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients

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

Persistence will be measured as two or more consecutive polymerase chain reaction (PCR) positive swabs for the same human papillomavirus (HPV) genotype. Will use Chi-Square test to compare the number of participants with the persistent infection in the vaccinated to unvaccinated group.

Analysis population: Participants were included in this analysis if they had 2 or more HPV DNA PCR results from swabs collected after the baseline swab. Of the 185 participants in the baseline population, 117 were 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)53
Arm II (Placebo)64

Reported measurements

Source class 1

HPV16 persistence identified

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)7Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)9Not reportedNot reportedNot reportedNot reported

HPV18/45 persistence identified

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

HPV31/33/52/58 persistence identified

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)3Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)11Not reportedNot reportedNot reportedNot reported

HPV33/39/51/56/59 persistence identified

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)4Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)8Not reportedNot reportedNot reportedNot reported

Overall high-risk HPV persistence identified

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)13Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)21Not reportedNot reportedNot reportedNot reported

High-risk HPV persistence NOT identified

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)23Not reportedNot reportedNot reportedNot reported
Arm II (Placebo)10Not 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 HPV16 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.89
    statistical Method
    Chi-squared
  2. group Description
    This p-value compares HPV18/45 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.65
    statistical Method
    Chi-squared
  3. group Description
    This p-value compares HPV31/33/52/58 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.056
    statistical Method
    Chi-squared
  4. group Description
    This p-value compares HPV35/39/51/56/59 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.38
    statistical Method
    Chi-squared
  5. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.33
    p Value Comment
    This p-value compares overall HPV persistence and is not specific to HPV genotype.
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Description
    This p-value compares HPV16 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.89
    statistical Method
    Chi-squared
  2. group Description
    This p-value compares HPV18/45 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.65
    statistical Method
    Chi-squared
  3. group Description
    This p-value compares HPV31/33/52/58 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.056
    statistical Method
    Chi-squared
  4. group Description
    This p-value compares HPV35/39/51/56/59 persistence by study arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.38
    statistical Method
    Chi-squared
  5. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.33
    p Value Comment
    This p-value compares overall HPV persistence and is not specific to HPV genotype.
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      title
      HPV16 persistence identified
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      title
      HPV18/45 persistence identified
    3. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        11
      title
      HPV31/33/52/58 persistence identified
    4. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
      title
      HPV33/39/51/56/59 persistence identified
    5. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        21
      title
      Overall high-risk HPV persistence identified
    6. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        10
      title
      High-risk HPV persistence NOT identified
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      64
    units
    Participants
description
Persistence will be measured as two or more consecutive polymerase chain reaction (PCR) positive swabs for the same human papillomavirus (HPV) genotype. Will use Chi-Square test to compare the number of participants with the persistent infection in the vaccinated to unvaccinated group.
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 were included in this analysis if they had 2 or more HPV DNA PCR results from swabs collected after the baseline swab. Of the 185 participants in the baseline population, 117 were included in this analysis.
reporting Status
POSTED
time Frame
Up to month 36
title
Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice