Effectiveness of HPV Vaccine in Thai Adult Women

Brief Title

Effectiveness of HPV Vaccine in Thai Adult Women

Official Title

Effectiveness of HPV Vaccine Among Women Age Equal or More Than 20 Years

Brief Summary

      -  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
    

Study Type

Observational

Primary Outcome

Occurrence of Low-grade squamous intraepithelial lesion or worse (LSIL+) associated with HPV 16 or 18

Secondary Outcome

 Cost-effectiveness of bivalent and quadrivalent HPV vaccination

Condition

Uterine Cervical Dysplasia

Intervention

Bivalent or Quadrivalent HPV vaccines

Study Arms / Comparison Groups

 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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

964

Start Date

November 21, 2018

Completion Date

December 2019

Primary Completion Date

November 2019

Eligibility Criteria

        Inclusion Criteria

        (vaccinated group)

          -  Thai women aged 20-45 years at the time of HPV vaccination

          -  Received at least 1 dose of bivalent or quadrivalent HPV vaccine at least 5 years ago

          -  Willing to provide written informed consent and receive Pap smear & HPV genotyping
             (only for those who need specimen collection for cervical cytology and HPV genotyping
             result)

        (control group)

          -  Thai women without history of HPV vaccination

          -  Received Pap smear result at their ages 20-45 years at least 5 years ago

          -  Willing to provide written informed consent and receive Pap smear & HPV genotyping
             (only for those who need specimen collection for cervical cytology and HPV genotyping
             result)

        Exclusion Criteria:

          -  Known pregnancy

          -  History of hysterectomy or excisional treatment of the cervix

          -  Known increased risk of bleeding

          -  Not willing to provide written informed consent
      

Gender

Female

Ages

25 Years - 53 Years

Contacts

Punnee Pitisuttithum, 6626435599, [email protected]

Location Countries

Thailand

Location Countries

Thailand

NCT ID

NCT03763565

Organization ID

HPV 021

Secondary IDs

2561.1/13

Responsible Party

Sponsor

Study Sponsor

Mahidol University

Collaborators

 National Vaccine Institute, Thailand

Study Sponsor

Punnee Pitisuttithum, Study Chair, Mahidol University

Verification Date

December 2018