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

Charles University, Czech Republic

Status: Completed

Conditions: Recurrence; Cervical Intraepithelial Neoplasia Grade 2/3

Treatments: Biological: vaccination against human papillomavirus infection (HPV vaccination)

Study type: Observational

Funder types: Other

Identifiers

NCT06258564

PAVIVE2024

Cooperatio 31 fund (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 12,000 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women >18 years, with conization for CIN2+ (HSIL)
• Women who had more than one examination during a follow-up period of >6 months.

Exclusion criteria

• Women who underwent hysterectomy after conization.

• Women who had excision procedures other than cervical excision.
• Women who did not undergo any other cytological/histological examinations.
• Women with more than one conization before CIN2+ recurrence

Trial design

12,000 participants in 1 patient group

single cohort of women with cervical excision for CIN2+

Description:

single cohort of women with cervical excision for CIN2+; those with HPV vaccination and those without HPV vaccination

Treatment:

Biological: vaccination against human papillomavirus infection (HPV vaccination)