Clinical trial · Observational

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

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

NCT05341284CI-TRIAL-00093633HPV-RWSwithdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Due to on-site coordination issues and lack of cooperation from the research site staff, the study was withdrawn.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Disease	—	UNRESOLVED	—
HPV Infection	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Questionnaire Survey and Cervical Cancer Screening	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

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

Primary outcomes (1)

measure
Number of Participants with Cervical infection with HPV-16 and/or HPV-18 (by PCR)
timeFrame
up to 36 month
description
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 9 Years
Maximum age: 45 Years

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDLiu 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. PMID 36401179