Randomized, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.
BioHPV is a randomized, double-blinded, placebo-controlled, multi-center, phase III trial evaluating nonavalent HPV (9vHPV) vaccine in 984 patients aged ≤55 undergoing HSIL treatment at any site (gynecological (i.e. vulvar, vaginal, cervical), anal, penile).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
984
HPV vaccine, 3 timepoints : month 0, month 1-2, month 6
Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6
Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.
To assess the efficacy of Human papilloma virus (HPV) vaccination as secondary prevention in patients with gynecological or anal HSIL.The endpoint will be the time to HPV type-specific recurrence of HSIL at the initial site after completed HSIL treatment.
Time frame: 4.5 years
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