Clinical trial NCT06220747: Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women
Official title: Effectiveness of Single Dose or Two Doses of HPV Vaccine Among Adolescents and Reproductive Women: A Test-negative Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hpv
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2024-01-24
Enrollment: 760
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: The real world effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among women aged 12-45
timeFrame: 1 visit (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
state: Select...
city: Bangkok
country: Thailand
facility: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,
Study officials:
affiliation: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
name: Punnee Pitisuttithum, Prof.
role: STUDY_CHAIR
References: