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INTRODUCTION: Human papilloma virus (HPV) causes cervical cancer. HPV vaccination is highly effective in primary prevention. There is less known about a possible effect of secondary prevention in women already infected with HPV. Our study proposes to investigate this efficacy in women with precursors of cervical cancer. This study is highly prioritized by the Dutch society of obstetrics and gynaecology.

 

RESEARCH QUESTION:

Does HPV vaccination after Loop Electrosurgical Excision Procedure(LEEP), reduce the recurrence of Cervical Intra-epithelial Neoplasia(CIN)II-III lesions?

 

HYPOTHESIS

HPV vaccination after LEEP for CIN reduces recurrence.

 

STUDY DESIGN

Multicenter randomized double blind placebo controlled trial

 

STUDY POPULATION

Adult female patients with CIN II-III treated with LEEP and no prior vaccination for HPV.

 

INTERVENTION

HPV-vaccination or placebo after LEEP.

 

USUAL CARE/COMPARISON

Follow-up at 6 and 24 months after LEEP (HPV and cytology), according to the Dutch guideline.

 

OUTCOME MEASURES

Primary outcome: CIN II-III at 24 months

Secondary: high risk HPV presence, cytology results, number of re-interventions, cost-effectivity, adverse events and quality of life.

 

Tertiary outcome measure is efficacy of the vaccination after 5 and 10 yrs. Following completion of the trial, long term outcomes from the national screening program for cervical cancer will be obtained at 5 and 10 years. (analysis is not budgeted in this ZonMW-application).

 

SAMPLE SIZE

With a power of 0.8 and a two-sided alpha of 0.050,an estimated incidence of 8%(HPV-vaccine) and 3%(placebo),at 2-year follow-up, for recurrence: 650 patients are needed. With 10-15% loss to follow-up a total of 750 patients has to be included.

 

DATA ANALYSIS

For the primary and secondary outcomes, the relative risk will be estimated comparing the vaccinated group to the placebo group, with 95% confidence intervals with chi-square or Fisher’s exact test for significance. All analyses will be intention-to-treat.

 

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