NCT06258564

The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization

The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Intraepithelial Neoplasia Grade 2 or Worse in Women Undergoing Conization: Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (actual)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: —

Summary

Assessment of the association between human papillomavirus vaccination (HPV) and recurrences of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women undergoing conization.

Detailed description

The implementation of vaccination against human papillomavirus (HPV) in the national immunization program for the young age cohort was subsequently extended to previously unvaccinated adult women who underwent conization due to cervical intraepithelial neoplasia grade 2 or worse (CIN2+). These women are offered HPV vaccination, often completed post-excision. Observational and clinical studies conducted between 2010 and 2023 have demonstrated that HPV vaccination contributes to a \>70% reduction in CIN2+ recurrence in women after conization. However, the outcomes of these studies have not conclusively shown whether the adjuvant effect of HPV vaccination depends on the vaccine type (bi-, quadri-, or nona-valent), the timing and completeness of vaccination, and other factors. This study aims to assess the mentioned factors and potentially reveal new ones, such as age, health status, etc. It is planned to be conducted using the laboratory records of women who underwent conization between 2010 and 2024, with their cervical screening examinations performed at the central laboratory UNILABS in Prague

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3
• Recurrence

Interventions

Type	Name	Description
BIOLOGICAL	vaccination against human papillomavirus infection (HPV vaccination)	Women with or without HPV vaccination before or after excision

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-12-31
• Completion: 2025-01-30
• First posted: 2024-02-14
• Last updated: 2025-02-13

Locations

2 sites across 1 country: Czechia