Impact of HPV Vaccination on HPV Infection and Cervical Related Disease Burden in Real-World Settings (HPV-RWS)

Not yet recruiting

• Conditions: HPV Infection; Cervical Disease
• Interventions: Other: Questionnaire Survey and Cervical Cancer Screening

• Registration Number: NCT05341284
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-29
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-22
• Last Update Submitted: 2022-04-24
• Last Update Posted: 2022-04-29
• Study Start: 2022-08-01
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 12118

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-exposed group	Questionnaire Survey and Cervical Cancer Screening	The subject who does not have any HPV vaccination history at the enrollment or during the study period.
Exposed group	Questionnaire Survey and Cervical Cancer Screening	The subject who is receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine at the enrollment.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Cervical infection with HPV-16 and/or HPV-18 (by PCR)	up to 36 month	HPV-16 and/or HPV-18 infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at enrollment (Month 0) or follow-up (Month 36) or any additional screenings during the study period.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Any cervical lesions or diseases	up to 36 month	Any cervical lesions or diseases is defined as atypical squamous cells of undefined significance (ASC-US), atypical glandular cells (AGC), atypical squamous cells, cannot exclude for highly squamous intraepithelial lesions (ASC-H), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), Cervical Intraepithelial Neoplasia (CIN) 1, CIN2, CIN3, squamous cell carcinoma (SCC), adenocarcinoma in situ (AIS) and adenocarcinoma (ADC). Any hr-HPV type infection is defined as at least one positive for HPV 16/18/31/33/35/39/45/51/52/56/58/59/66/68 or multiple types DNA PCR assay in the aforesaid cervical sample.
The occurrence of high-risk HPV infection 12 other hr-HPV positive besides of type 16/18	up to 36 month	12 other hr-HPV positive besides of type 16/18 infection is defined as at least one positive for HPV 31/33/35/39/45/51/52/56/58/59/66/68 or multiple types DNA PCR assay at enrollment (Month 0) or follow-up (Month 36) or any additional screenings during the study period.