Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases

• Conditions: HPV Vaccination、HPV Related Diseases、Protective Efficacy
• Interventions: Biological: HPV vaccine

• Registration Number: NCT05085093
• Lead Sponsor: Xijing Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-18
• Study First Submitted: 2021-10-17
• Study First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Study First Posted: 2021-10-20
• Last Update Posted: 2021-10-20
• Primary Completion: 2022-03-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 414

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	HPV vaccine	HPV vaccine group

Primary Outcome Measures

Name	Time	Method
Persistent HPV infection	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
recurrence	6 months after operation	If The lesions were found again more than 6 months after operation (pathological diagnosis)

Trial Locations

Locations (1)

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