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OncoMatch/Clinical Trials/NCT06793410

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

Is NCT06793410 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Early start post-transplant vaccination with Gardasil 9® and Late post-transplant vaccination with Gardasil 9® for recipients of allogeneic stem cell transplantation.

Phase 2RecruitingVastra Gotaland RegionNCT06793410Data as of May 2026

Treatment: Early start post-transplant vaccination with Gardasil 9® · Late post-transplant vaccination with Gardasil 9®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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Prior therapy

Must have received: stem cell transplant — allogeneic

Recipient of AlloSCT from related or unrelated donor

Cannot have received: rituximab (rituximab)

Exception: Doses given later (unusual) do not require exclusion

Treatment with rituximab 6 months before start of vaccination

Cannot have received: immunoglobulin

Treatment within 3 months before start of vaccination with iv or sc immunoglobulin

Lab requirements

Blood counts

Severe thrombocytopenia (under 50 x 10^9) not allowing intramuscular injection

Severe thrombocytopenia (under 50 x 10^9) not allowing intramuscular injection

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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