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

What this Trial Is About

Researchers are evaluating how well receiving one or two doses of the HPV vaccine protects against high-risk HPV infections in females aged 12 to 45. This study uses a test-negative control design, enrolling women interested in getting a pap smear check-up. Women who test positive for HPV DNA are classified as cases, while those testing negative serve as controls, with nine controls matched to each case. Data on demographics and vaccine history will be collected through interviews and questionnaires to help understand factors affecting vaccine effectiveness. Participants will undergo HPV DNA testing using urine samples or optional self-collected cervical samples. If a participant has an HPV test result from within the past year, that result will be used without repeating the test. No treatments or interventions are administered as this is an observational study focused on collecting data and assessing vaccine impact in a real-world setting. During the study, participants will be interviewed about their background and vaccination history. Researchers will also collect self-reported information about other factors that might influence results. The main outcome measured is the effectiveness of receiving two doses or less of the HPV vaccine in preventing high-risk HPV infection, assessed in one visit lasting one day. The study is sponsored by Mahidol University and involves healthy volunteers who meet the eligibility criteria.

Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women