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

Sponsor
Vastra Gotaland Region
Study ID
NCT06793410
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukaemia
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • HPV (Human Papillomavirus)-Associated
  • Myelodysplastic Syndrome
  • Recipients of Allogeneic Stem Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 27, 2025
Start date
May 12, 2025
Status verified
May 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Late vaccination group
    Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.
  • Experimental: Early vaccination group
    Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after stem cell transplantation.

Primary Outcome Measure

Primary outcome - GMT level against HPV 16 [ Time Frame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant. ]

Central Contacts

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