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Effectiveness of HPV Vaccine in Thai Adult Women

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ClinicalTrials.gov Identifier: NCT03763565
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
National Vaccine Institute, Thailand
Chulalongkorn University
National Cancer Institute, Thailand
Bumrungrad International Hospital
Information provided by (Responsible Party):
Mahidol University

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

Condition or disease Intervention/treatment
Uterine Cervical Dysplasia Papillomavirus Vaccines Biological: Bivalent or Quadrivalent HPV vaccines

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Study Type : Observational
Estimated Enrollment : 964 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness of HPV Vaccine Among Women Age Equal or More Than 20 Years
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Vaccinated group
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
Biological: Bivalent or Quadrivalent HPV vaccines
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
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 53 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population

Vaccinated group: Thai women who received at least one dose of HPV vaccination, either by bivalent or quadrivalent HPV vaccine when they were 20-45 years old at least 5 years ago from the current enrollment time

Control group: Women who did not receive any HPV vaccination, but received Pap smear result (conventional or liquid-based) when they were 20-45 years at least 5 years ago from the current enrollment time

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763565


Contacts
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Contact: Punnee Pitisuttithum 6626435599 punnee.pit@mahidol.ac.th
Contact: GA YOUNG LEE 66945525330 ga.young.lydia@gmail.com

Locations
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Thailand
Bumrungrad International Hospital Recruiting
Bangkok, Thailand, 10110
Contact: Rasik Rangsiprakarn         
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Wichai Termrungruanglert         
National Cancer Institute, Thailand Not yet recruiting
Bangkok, Thailand, 10400
Contact: Piyawat Laowahutanont         
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Recruiting
Bangkok, Thailand, 10400
Contact: Punnee Pitisuttithum    662-6435599    punnee.pit@mahidol.ac.th   
Principal Investigator: Punnee Pitisuttithum         
Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Perapong Inthasorn         
Sponsors and Collaborators
Mahidol University
National Vaccine Institute, Thailand
Chulalongkorn University
National Cancer Institute, Thailand
Bumrungrad International Hospital
Investigators
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Study Chair: Punnee Pitisuttithum Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03763565     History of Changes
Other Study ID Numbers: HPV 021
2561.1/13 ( Other Grant/Funding Number: National Vaccine Institute, Thailand )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Vaccines
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs