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Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases

NCT ID: NCT05085093

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-18

Study Completion Date

2024-09-01

Brief Summary

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To understand the HPV infection status and subtype distribution of patients, and to study the protective effect of prophylactic HPV vaccination on the recurrence of HPV related diseases after treatment through a prospective cohort study. To provide data support for the primary prevention of HPV related diseases in Chinese women after treatment, and to analyze the related factors of HPV related disease recurrence and HPV continuous positive.

Detailed Description

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Conditions

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HPV Vaccination、HPV Related Diseases、Protective Efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

HPV vaccine group

HPV vaccine

Intervention Type BIOLOGICAL

Patients choose to be vaccinated or not to be vaccinated with HPV vaccine according to their own wishes

Control group

non HPV vaccine group

No interventions assigned to this group

Interventions

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HPV vaccine

Patients choose to be vaccinated or not to be vaccinated with HPV vaccine according to their own wishes

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 1\. Women aged 18-45, of childbearing age or before perimenopause (patients without pregnancy plan within two years); 2. Patients diagnosed as condyloma acuminatum, vaginal intraepithelial lesions (high-grade and low-grade lesions), cervical intraepithelial lesions (high-grade and low-grade lesions), vulvar intraepithelial lesions (high-grade and low-grade lesions), cervical cancer (IA1-IIA2 stage) and treated within 3 months; 3. No surgical contraindications such as severe center of heart, lung and other organ dysfunction and abnormal hemagglutination; 4. Fully know the treatment method, sign informed consent, and actively cooperate with follow-up.

Exclusion Criteria

* 1\. Participating in other clinical trials; 2. Use immunoglobulin or blood products within 3 months before vaccination; 3. Hypersensitivity to vaccine active ingredients or any dressing ingredients; 4. Acute stage of moderate and severe diseases; 5. Acute stage of severe immune deficiency diseases and autoimmune diseases; 6. Pregnant women and lactating patients; 7. Patients with planned pregnancy within 2 years; 8. Less than 18 years old and more than 45 years old.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hong Yang, professional

Role: STUDY_CHAIR

The First Affiliated Hospital，Air Force Medical University,Xi'an, Shaanxi, China

Locations

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The First Affiliated Hospital, Air Force Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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KY20212121

Identifier Type: -

Identifier Source: org_study_id