Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases

NCT05085093 | Unknown FDA Drug

• 1 other identifier: KY20212121
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Vaccination、HPV Related Diseases、Protective Efficacy

Outcome Measures

Primary Outcomes (2)

• recurrence

  If The lesions were found again more than 6 months after operation (pathological diagnosis)

  6 months after operation

• Persistent HPV infection

  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

Study Arms (2)

Study Group

HPV vaccine group

Biological: HPV vaccine

Control group

non HPV vaccine group

Interventions

HPV vaccine BIOLOGICAL

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

Study Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The diseases in this study mainly occurred in female groups
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients with HPV related diseases

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital, Air Force Medical University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• hong Yang, professional

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 20, 2021
• Study Start: September 18, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2024
• Last Updated: October 20, 2021

Record last verified: 2021-09

Locations

CN (1)