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

NCT05341284 | Withdrawn

• 1 other identifier: HPV-RWS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HPV Infection; Cervical Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Cervical infection with HPV-16 and/or HPV-18 (by PCR)

  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.

  up to 36 month

Secondary Outcomes (2)

• The occurrence of high-risk HPV infection 12 other hr-HPV positive besides of type 16/18

  up to 36 month

• Number of Participants with Any cervical lesions or diseases

  up to 36 month

Study Arms (2)

Exposed group

The subject who is receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine at the enrollment.

Other: Questionnaire Survey and Cervical Cancer Screening

Non-exposed group

The subject who does not have any HPV vaccination history at the enrollment or during the study period.

Other: Questionnaire Survey and Cervical Cancer Screening

Interventions

Questionnaire Survey and Cervical Cancer Screening OTHER

A brief questionnaire will be administered to all participants at enrollment and at the pre-scheduled follow-up visit at Month 36. For the subject who are eligible for the screening (i.e. (1)≥ 18 years old; (2) had sexual debut prior to enrollment, (3) no contradiction to the screening, (4) voluntary to the screening) will be referred to the study site hospitals by offering the subjects a cervical cancer screening voucher, and the type-specific HPV test will be performed as primary screening approach at Month 0 and 36.

Exposed group; Non-exposed group

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Center for Disease Control and Prevention of Yinzhou District, Ningbo City, China: collaborator
• GlaxoSmithKline: collaborator

Related Publications (1)

• 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.

  PMID: 36401179 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Diseases

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 22, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 14, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share