Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

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: Hpv

• Study Type: Observational
• Enrollment (Estimated): 760

Contacts and Locations

• 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

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

How is the study designed?

Number of groups / cohorts

1

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	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

• 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

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: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NRCT9-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No