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

Recruiting now · Phase 2

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

In brief

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 facts

Study ID

NCT06793410

Run by

Vastra Gotaland Region

People needed

100

Starts

2025-05-12

Expected to finish

2029-10-31

Last updated by the study team

2025-06-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Uppsala University Hospital — Uppsala, Region Uppsala, Sweden (enrolling)
• Linköping University Hospital — Linköping, Region Östergötaland, Sweden (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Västra Götalands Region, Sweden (enrolling)
• Skåne's University Hospital — Lund, Region Skåne, Sweden
• Karolinska University Hospital — Stockholm, Region Stockholm, Sweden

Full record on ClinicalTrials.gov

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