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Набор скоро начнётся NCT07431502

Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions

Фаза III С лечением Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile Site Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical Site

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HPV vaccine, Placebo vaccine.
Кому может быть актуально
Состояния в реестре: Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vulvar Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Vaginal Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Penile Site, Patients With Primary HPV High-grade Squamous Intra-epithelial Lesions (HSIL) at Cervical Site. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Биопрепарат HPV vaccine
    HPV vaccine, 3 timepoints : month 0, month 1-2, month 6
  • Биопрепарат Placebo vaccine
    Placebo vaccine, 3 timepoints : month 0, month 1-2, month 6

Первичные конечные точки

  • Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed. [Срок оценки: 4.5 years]

Критерии участия

Критерии включения

  • Women, men, transgender,18 ≤age ≤55
  • ECOG performance status ≤ 1
  • Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load.
  • Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile PeIN) at baseline.
  • Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection.
  • Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine.
  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be affiliated to a social security system or beneficiary of the same
  • Life expectancy of greater than 5 years

Критерии исключения

  • History of HPV related cancer (i.e. anal, genital, head and neck, cutaneous, penile)
  • History of prior treatment of HSIL
  • Warts so extensive that they preclude the clinician from determining the extent and location of HSIL Prior HPV vaccination
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of trial treatment.
  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
  • Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of >95%.
  • Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC).
  • Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered.
  • Pregnant women or intent to become pregnant
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07431502 · 2024-520140-42-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗