Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases

October 19, 2021 updated by: Xijing Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

414

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • the First Affiliated Hospital, Air Force Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All patients with HPV related diseases

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
HPV vaccine group
Biological: HPV vaccine
Patients choose to be vaccinated or not to be vaccinated with HPV vaccine according to their own wishes
Control group
non HPV vaccine group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 6 months after operation
If The lesions were found again more than 6 months after operation (pathological diagnosis)
6 months after operation
Persistent HPV infection
Time Frame: At least 12 months
At least 12 months apart, cervical vaginal / external genital swabs or tissue biopsies were taken for 2 or more consecutive times, and HPV detection and analysis showed that the same HPV type was positive
At least 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: hong Yang, professional, The First Affiliated Hospital，Air Force Medical University,Xi'an, Shaanxi, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • KY20212121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We haven't decided whether to share the data yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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