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Completed

NCT Number: NCT03763565

Effectiveness of HPV Vaccine in Thai Adult Women

* 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

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Key information

Age range

25 year–53 year

Sex eligibility

Female

Study type

Observational

Primary location

Bumrungrad International Hospital, Bangkok, Thailand

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bivalent or Quadrivalent HPV vaccines

Biological

Vaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years

Control Group

Other

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

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. 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.

    Direct and and indirect cost survey interview associated with HPV vaccination and its cost-effectiveness

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Bumrungrad International Hospital
  • Chulalongkorn University
  • National Cancer Institute, Thailand
  • National Vaccine Institute, Thailand
  • Siriraj Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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