Bivalent or Quadrivalent HPV vaccines
BiologicalVaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years
NCT Number: NCT03763565
* 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
Looking for future studies?
Notify Me25 year–53 year
Female
Observational
Bumrungrad International Hospital, Bangkok, Thailand
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(vaccinated group)
(control group)
Exclusion criteria
Vaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years
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
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
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
Mahidol University
Other
Effectiveness of HPV Vaccine Among Women Age Equal or More Than 20 Years
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.
Published trials that share one or more normalized conditions with this study.
NCT01639820
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Bron, France
View Trial DetailsNCT04415840
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Dortmund, North Rhine-Westphalia, Germany
View Trial DetailsNCT04326049
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Herne, North Rhine-Westphalia, Germany
View Trial DetailsNCT02330471
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Bochum, Germany
View Trial Details