<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03763565</url>
  </required_header>
  <id_info>
    <org_study_id>HPV 021</org_study_id>
    <secondary_id>2561.1/13</secondary_id>
    <nct_id>NCT03763565</nct_id>
  </id_info>
  <brief_title>Effectiveness of HPV Vaccine in Thai Adult Women</brief_title>
  <official_title>Effectiveness of HPV Vaccine Among Women Age Equal or More Than 20 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Vaccine Institute, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bumrungrad International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Siriraj Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Background: The majority of the burden of HPV-related cervical cancer is in developing&#xD;
           countries while most of the effectiveness reports of HPV vaccination are currently&#xD;
           coming from developed countries. Also, currently many adult women are left without&#xD;
           either HPV vaccination or cervical cancer screening. Effectiveness data of currently&#xD;
           available HPV vaccines among adult women in developing countries are needed for women&#xD;
           and healthcare workers and policy makers to best protect women from cervical cancer.&#xD;
&#xD;
        -  Primary Study Objective:&#xD;
&#xD;
           - To determine the effectiveness bivalent and quadrivalent HPV vaccines in reduction of&#xD;
           cervical dysplasia (Low-grade Squamous Intraepithelial Lesion or worse; LSIL+)&#xD;
           attributable to HPV types 16 or 18 after at least 5 years of vaccination among Thai&#xD;
           women vaccinated at their ages 20-45 years with at least one dose of the HPV vaccine&#xD;
&#xD;
        -  Secondary Study Objectives:&#xD;
&#xD;
             -  To measure the effectiveness of currently available bivalent and quadrivalent HPV&#xD;
                vaccines in reducing the prevalence of HPV 16 or 18&#xD;
&#xD;
             -  To measure the effectiveness of HPV vaccines in reducing any abnormal Pap smear&#xD;
                result (ASC-US+)&#xD;
&#xD;
             -  To compare the effectiveness of HPV vaccines according to the number of doses&#xD;
                immunized&#xD;
&#xD;
             -  To find out risk factor(s) for HPV 16 or 18-related cervical dysplasia in this&#xD;
                cohort&#xD;
&#xD;
             -  To assess the prevalence of other high-risk HPV types in vaccinated and&#xD;
                non-vaccinated group&#xD;
&#xD;
             -  To determine direct and/or indirect cost of HPV vaccination&#xD;
&#xD;
        -  The hypothesis to be tested: At least one dose of vaccination with bi- or quadri-valent&#xD;
           HPV vaccine will reduce the prevalence of LSIL+ attributable to HPV 16/18 by 80% after&#xD;
           at least 5 years of vaccination.&#xD;
&#xD;
        -  Materials and Methods: This study will be a retrospective matched cohort study. Data is&#xD;
           to be collected either by from samples for Pap and HPV test and/or HPV 16/18 genotyping&#xD;
           of the recruited participants, or from existing medical records. HPV vaccinated women at&#xD;
           their ages 20-45 years (vaccinated group) and women received Pap smear at their ages&#xD;
           20-45 years without vaccination (control group) will be included in the study. Pap smear&#xD;
           and HPV test and/or HPV 16/18 typing result of 2 groups will be compared after ≥ 5 years&#xD;
           of vaccination or baseline Pap smear. Those who don't have Pap smear results ≥ 5 years&#xD;
           after vaccination or ≥ 5 years after the baseline Pap smear will be offered for a Pap&#xD;
           smear and HPV 16/18 typing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Low-grade squamous intraepithelial lesion or worse (LSIL+) associated with HPV 16 or 18</measure>
    <time_frame>Sample collection in the project is single 1 day time for participants who received vaccination at least 5 years ago.</time_frame>
    <description>LSIL or worse, including Atypical Glandular Cells, High-grade squamous intraepithelial lesion, Cervical intraepithelial neoplasia (CIN) grade 1-3, and cervical cancer which are associated with either HPV 16 or 18</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of bivalent and quadrivalent HPV vaccination</measure>
    <time_frame>Interview for direct and indirect cost survey will be single 1 day time for a participant.</time_frame>
    <description>Direct and and indirect cost survey interview associated with HPV vaccination and its cost-effectiveness</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">993</enrollment>
  <condition>Uterine Cervical Dysplasia</condition>
  <condition>Papillomavirus Vaccines</condition>
  <arm_group>
    <arm_group_label>Vaccinated group</arm_group_label>
    <description>Thai women who received at least one dose HPV vaccination at least 5 years ago, either by Bivalent or Quadrivalent HPV vaccines when they were 20-45 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Thai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bivalent or Quadrivalent HPV vaccines</intervention_name>
    <description>Vaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years</description>
    <arm_group_label>Vaccinated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Thai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Vaccinated group: Thai women who received at least one dose of HPV vaccination, either by&#xD;
        bivalent or quadrivalent HPV vaccine when they were 20-45 years old at least 5 years ago&#xD;
        from the current enrollment time&#xD;
&#xD;
        Control group: Women who did not receive any HPV vaccination, but received Pap smear result&#xD;
        (conventional or liquid-based) when they were 20-45 years at least 5 years ago from the&#xD;
        current enrollment time&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        (vaccinated group)&#xD;
&#xD;
          -  Thai women aged 20-45 years at the time of HPV vaccination&#xD;
&#xD;
          -  Received at least 1 dose of bivalent or quadrivalent HPV vaccine at least 5 years ago&#xD;
&#xD;
          -  Willing to provide written informed consent and receive Pap smear &amp; HPV genotyping&#xD;
             (only for those who need specimen collection for cervical cytology and HPV genotyping&#xD;
             result)&#xD;
&#xD;
        (control group)&#xD;
&#xD;
          -  Thai women without history of HPV vaccination&#xD;
&#xD;
          -  Received Pap smear result at their ages 20-45 years at least 5 years ago&#xD;
&#xD;
          -  Willing to provide written informed consent and receive Pap smear &amp; HPV genotyping&#xD;
             (only for those who need specimen collection for cervical cytology and HPV genotyping&#xD;
             result)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  History of hysterectomy or excisional treatment of the cervix&#xD;
&#xD;
          -  Known increased risk of bleeding&#xD;
&#xD;
          -  Not willing to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>53 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Punnee Pitisuttithum</last_name>
    <role>Study Chair</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bumrungrad International Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute, Thailand</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03763565
org study id: HPV 021
secondary id: 2561.1/13
nct id: NCT03763565
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
-  Background: The majority of the burden of HPV-related cervical cancer is in developing
           countries while most of the effectiveness reports of HPV vaccination are currently
           coming from developed countries. Also, currently many adult women are left without
           either HPV vaccination or cervical cancer screening. Effectiveness data of currently
           available HPV vaccines among adult women in developing countries are needed for women
           and healthcare workers and policy makers to best protect women from cervical cancer.

        -  Primary Study Objective:

           - To determine the effectiveness bivalent and quadrivalent HPV vaccines in reduction of
           cervical dysplasia (Low-grade Squamous Intraepithelial Lesion or worse; LSIL+)
           attributable to HPV types 16 or 18 after at least 5 years of vaccination among Thai
           women vaccinated at their ages 20-45 years with at least one dose of the HPV vaccine

        -  Secondary Study Objectives:

             -  To measure the effectiveness of currently available bivalent and quadrivalent HPV
                vaccines in reducing the prevalence of HPV 16 or 18

             -  To measure the effectiveness of HPV vaccines in reducing any abnormal Pap smear
                result (ASC-US+)

             -  To compare the effectiveness of HPV vaccines according to the number of doses
                immunized

             -  To find out risk factor(s) for HPV 16 or 18-related cervical dysplasia in this
                cohort

             -  To assess the prevalence of other high-risk HPV types in vaccinated and
                non-vaccinated group

             -  To determine direct and/or indirect cost of HPV vaccination

        -  The hypothesis to be tested: At least one dose of vaccination with bi- or quadri-valent
           HPV vaccine will reduce the prevalence of LSIL+ attributable to HPV 16/18 by 80% after
           at least 5 years of vaccination.

        -  Materials and Methods: This study will be a retrospective matched cohort study. Data is
           to be collected either by from samples for Pap and HPV test and/or HPV 16/18 genotyping
           of the recruited participants, or from existing medical records. HPV vaccinated women at
           their ages 20-45 years (vaccinated group) and women received Pap smear at their ages
           20-45 years without vaccination (control group) will be included in the study. Pap smear
           and HPV test and/or HPV 16/18 typing result of 2 groups will be compared after ≥ 5 years
           of vaccination or baseline Pap smear. Those who don't have Pap smear results ≥ 5 years
           after vaccination or ≥ 5 years after the baseline Pap smear will be offered for a Pap
           smear and HPV 16/18 typing
observational model: Cohort
time perspective: Retrospective
measure: Occurrence of Low-grade squamous intraepithelial lesion or worse (LSIL+) associated with HPV 16 or 18
time frame: Sample collection in the project is single 1 day time for participants who received vaccination at least 5 years ago.
description: LSIL or worse, including Atypical Glandular Cells, High-grade squamous intraepithelial lesion, Cervical intraepithelial neoplasia (CIN) grade 1-3, and cervical cancer which are associated with either HPV 16 or 18
measure: Cost-effectiveness of bivalent and quadrivalent HPV vaccination
time frame: Interview for direct and indirect cost survey will be single 1 day time for a participant.
description: Direct and and indirect cost survey interview associated with HPV vaccination and its cost-effectiveness
arm group label: Vaccinated group
description: Thai women who received at least one dose HPV vaccination at least 5 years ago, either by Bivalent or Quadrivalent HPV vaccines when they were 20-45 years old
arm group label: Control group
description: Thai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time
intervention type: Biological
intervention name: Bivalent or Quadrivalent HPV vaccines
description: Vaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years
arm group label: Vaccinated group
intervention type: Other
intervention name: Control group
description: Thai women who did not receive HPV vaccination, either by bivalent or quadrivalent HPV vaccine but have received Pap smear at their ages 20-45 years at least 5 years ago from the current enrollment time
arm group label: Control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 53 Years
last name: Punnee Pitisuttithum
role: Study Chair
affiliation: Mahidol University
facility: 
facility: 
facility: 
facility: 
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Uterine Cervical Dysplasia