Меню
Идёт набор NCT06793410

Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation

Фаза II С лечением Recipients of Allogeneic Stem Cell Transplantation HPV (Human Papillomavirus)-Associated Acute Myeloid Leukaemia Myelodysplastic Syndrome

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: Early start post-transplant vaccination with Gardasil 9®, Late post-transplant vaccination with Gardasil 9®.
Кому может быть актуально
Состояния в реестре: Recipients of Allogeneic Stem Cell Transplantation, HPV (Human Papillomavirus)-Associated, Acute Myeloid Leukaemia, Myelodysplastic Syndrome. Базовые параметры: 18 лет — 45 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation

Обзор

Patients who undergo allogeneic stem cell transplantation lose previously acquired immunity and are routinely revaccinated against many infectious diseases. For several reasons, these patients have a long-term immune deficiency due to the transplant itself (lack of immune reconstitution) and due to possible complications, primarily GvHD and its treatment. The risk of secondary malignancy in the long-term following an allogeneic bone marrow transplant is greatly increased, and secondary cancer cases account for a significant proportion of late deaths in both women and men after transplantation. Some of these secondary cancers are associated with HPV. The risk of cervical cancer has been reported to be 13 times increased compared to a healthy population. Therefore in this trial, the aim is to study immune response (antigen-specific antibody response) after vaccination with 9-valent HPV vaccine (Gardasil 9®) in adult women and men (up to and including 45 years of age) who have undergone allogeneic stem cell transplantation. In this trial, the sponsor will compare "early" (start 9 months after tx) with "late" (start 15 months after tx) vaccination.

Вмешательства

  • Биопрепарат Early start post-transplant vaccination with Gardasil 9®
    Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after transplantation.
  • Биопрепарат Late post-transplant vaccination with Gardasil 9®
    Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.

Первичные конечные точки

  • Primary outcome - GMT level against HPV 16 [Срок оценки: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.]
Вторичные конечные точки (5)
  • Secondary outcome 1 - GMT level against all 9 HPV-serotypes [Срок оценки: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.]
  • Secondary Outcome 2 - GMT level against all 9 HPV-serotypes [Срок оценки: Early group: at month 27 posttransplant. Late group: at month 33 posttransplant.]
  • Secondary Outcome 3 - Proportion seropositive/negative against 9 HPV-serotypes [Срок оценки: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.]
  • Secondary Outcome 4 - Seroconversion against 9 HPV-serotypes [Срок оценки: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.]
  • Secondary Outcome 5 - Proportion seropositive against 7/9 HPV-types [Срок оценки: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.]

Критерии участия

Критерии включения

  • Recipient of AlloSCT from related or unrelated donor.
  • Adults (men and women) ≥18 years up to and including 45 years of age for vaccination.
  • Patients can be included regardless of prior HPV vaccination prior to transplantation

Критерии исключения

  • Severe thrombocytopenia (under 50 x 10\^9) not allowing intramuscular injection
  • Severe acute GvHD grade III-IV.
  • Extensive chronic GvHD requiring treatment with prednisone doses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photopheresis).
  • Prednisone doses above 1mg/kg/day at study start.
  • Treatment with rituximab 6 months before start of vaccination. Doses given later (unusual) do not require exclusion.
  • Treatment within 3 months before start of vaccination with iv or sc immunoglobulin.
  • Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose.
  • Treatment with blood thinning medication contraindicating intramuscular injection
  • Allergy against Gardasil 9

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
Открытое
Основная цель
Профилактика

Центры проведения

Швеция · 5 центров
  • Skåne's University Hospital — Lund
  • Karolinska University Hospital — Stockholm
  • Uppsala University Hospital — Uppsala
  • Linköping University Hospital — Linköping
  • Sahlgrenska University Hospital — Gothenburg

Идентификаторы

NCT: NCT06793410 · ALLO-HPV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗