Human papilloma virus (HPV) VACcination after surgical treatment of precursor lesions for cervical cancer.

Phase 1

• Conditions: Human papilloma virus (HPV) causes cervical cancer. HPV vaccination is highly effective in primary prevention. There is less known about a possible secondary effect in women already infected with HPV. Our study proposes to investigate this efficacy in women with precursors of cervical cancer. HPV vaccination after surgical treatment to evaluate the efficacy to prevent recurrent disease.; MedDRA version: 20.0Level: LLTClassification code 10028986Term: Neoplasm cervixSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-002764-94-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-13
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

Women 18 years or above
Histologically proven CIN II or III
Patients treated with LEEP
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 725
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Prior HPV vaccination
(Micro-) invasive carcinoma
Immune-compromised patients
Pregnancy
Prior treatment for CIN-lesions
Insufficient understanding of the Dutch language
Women allergic to vaccine components

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified