Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

October 7, 2024 updated by: Punnee Pitisuttithum, Mahidol University

Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study

To assess the effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among adolescents and adults. We conduct the test-negative control study including 12-45 women who interest to do a check-up pap smear. Cases were women who met the inclusion criteria and tested positive for HPV DNA, and controls were defined as women who met inclusion criteria but tested negative. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will be interviewed about their demographics and vaccine histories. Potential confounders data will be collected by interview or self- report questionnaire. HPV DNA test will be done by urine or self-cervical sampling (optional). In case the participant has previous HPV test result within 1 year, the result will be recorded and analysed without repeating the test.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Supitcha Kamolratanakul, Asst.Prof.
Phone Number: 66 81 699 6660
Email: supitcha.kam@mahidol.edu

Study Locations

Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,
    - Principal Investigator:
      
      Punnee Pitisuttithum, MD
    - Contact:
      
      Punnee Pitisuttithum, MD
      
      Phone Number: +66818294906
      
      Email: punnee.pit@mahidol.ac.th
- Select...
  - Bangkok, Select..., Thailand, 10400
    - Recruiting
    - Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Target populations are any women aged 12-45-year-old who interest this project.

For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will selection based on their outcome, not based on exposure. Cases were women who met the inclusion criteria and tested positive for HPV DNA (self-cervical swab/ urine sample: positive), and controls were defined as women who met inclusion criteria but HPV DNA tested negative.

Description

Inclusion Criteria:

Women aged 12-45 who willing to do HPV test check-up.
Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
Based on clinical judgment, the participant with underlying chronic disease who has stable and well-controlled medical conditions.

Exclusion Criteria:

Participant with history of total hysterectomy and loop electrosurgical excision procedure.
Participant who received 3 doses HPV vaccine.
Any condition that might confound the interpretation of vaccine effectiveness by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
women aged 12-45 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The real world effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among women aged 12-45 Time Frame: 1 visit (1 day)	Estimation of overall vaccine effectiveness For the planned analyses, the log odds of disease for individuals in matched sets will be modelled using the following conditional logistic model:Model 1 : Log (oddcase) = α¬i + β e(HPV_vaccination) + β1(cov_1) +β2(cov_2) + ... + βk(cov_k)where αi is the stratum-specific constant term for each matched set, βe is the parameter coefficient for the exposure of interest (receipt of HPV vaccine), and β1 through βk are the parameter coefficients for each covariate included in the model to control for confounding. Our modelling strategy will be to create models that always contain the exposure variable of interest (receipt of HPV vaccine) and additional covariates as needed.	1 visit (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

National Research Council of Thailand

Investigators

Study Chair: Punnee Pitisuttithum, Prof., Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria