Assessing the effectiveness of the HPV vaccine in young women
Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study
Mahidol University · NCT06220747
This study is testing if getting two or fewer doses of the HPV vaccine can help prevent high-risk HPV infections in women aged 12 to 45.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 760 (estimated) |
| Ages | 12 Years to 45 Years |
| Sex | Female |
| Sponsor | Mahidol University (other) |
| Locations | 2 sites (Bangkok, Select... and 1 other locations) |
| Trial ID | NCT06220747 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of receiving two or fewer doses of the HPV vaccine in preventing high-risk HPV infections among women aged 12 to 45. It employs a test-negative control design, enrolling women who are undergoing a Pap smear check-up, with cases being those who test positive for HPV DNA and controls being those who test negative. Participants will provide demographic information and vaccine history through interviews or questionnaires, and HPV DNA testing will be conducted via urine or self-cervical sampling. The study aims to gather data on vaccine effectiveness while considering potential confounding factors.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 12 to 45 who are willing to undergo an HPV test as part of a check-up.
Not a fit: Patients who have had a total hysterectomy or have received three doses of the HPV vaccine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the HPV vaccine, potentially leading to improved vaccination strategies and reduced HPV-related health issues.
How similar studies have performed: Other studies have shown varying degrees of success in assessing HPV vaccine effectiveness, but this specific approach using a test-negative control design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok, Select... and 1 other locations
- Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University — Bangkok, Select..., Thailand (RECRUITING)
- Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, — Bangkok, Thailand (RECRUITING)
Study contacts
- Study coordinator: Supitcha Kamolratanakul, Asst.Prof.
- Email: supitcha.kam@mahidol.edu
- Phone: 66 81 699 6660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hpv