Clinical trial NCT05341284: Impact of HPV Vaccination on HPV Infection and Cervical Related Disease Burden in Real-World Settings (HPV-RWS)
Official title: Impact of HPV Vaccination on HPV Infection and Cervical Related Disease Burden in Real-World Settings (HPV-RWS): A Prospective Cohort
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HPV Infection
Cervical Disease
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China
name: GlaxoSmithKline
First posted: 2022-04-22
Enrollment: 12118
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll the permanent female residents between 9 to 45 years old in the Yinzhou District, with AS04 adjuvanted HPV 16/18 vaccination history or without any HPV vaccination history.

Brief summary: Take AS04 adjuvanted HPV16/18 vaccine as an example to evaluate the impact of HPV vaccination on HPV infection and related disease burden in the real world based on prospective cohort and Yinzhou Regional Health Information Platform (YRHIP), in order to bridge the gap in relevant evidence in China.


Eligibility criteria: Inclusion Criteria:

* Permanent female resident in the Yinzhou District (i.e. at least residing in the Yinzhou District for a 3-year period and at least 6months in every 12-month period).
* Between 9 and 45 years old at time of the enrollment.
* Receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine (exposed group). Or without any HPV vaccination history (non-exposed group).
* Subjects and their parents / legal guardians agreed to comply with the requirements mentioned in the protocol (e.g., physically and mentally healthy, be able to complete the baseline and follow-up survey and would comply with the visits, etc.).
* Written informed consent will be obtained from the subject. For subjects who are below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject according to EC requirement as well as local law. Subjects must understand the protocol and be voluntarily willing to join this study with written informed consent form.

Exclusion Criteria:

* Pregnancy at the enrollment.
* Females with historical cervical diseases (i.e., CIN1, CIN2, CIN3, and cervical cancer) before the recruitment.
* After hysterectomy.
* Females with malignant tumor history or other severe diseases (e.g., liver failure, heart failure, etc.) whose life expectancy is less than 12 months.
* Females who (1) have historical HPV vaccination, or (2) are in non-exposed groups but have clear intention for HPV vaccination in next 3 years.

Primary outcomes:
measure: Number of Participants with Cervical infection with HPV-16 and/or HPV-18 (by PCR)
timeFrame: up to 36 month
Secondary outcomes:
measure: The occurrence of high-risk HPV infection 12 other hr-HPV positive besides of type 16/18
timeFrame: up to 36 month
measure: Number of Participants with Any cervical lesions or diseases
timeFrame: up to 36 month
Other outcomes:
Locations:
Study officials:
References:
citation: Liu Z, Li P, Zeng X, Yao X, Sun Y, Lin H, Shen P, Sun F, Zhan S. Impact of HPV vaccination on HPV infection and cervical related disease burden in real-world settings (HPV-RWS): protocol of a prospective cohort. BMC Public Health. 2022 Nov 18;22(1):2117. doi: 10.1186/s12889-022-14474-1.