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

Vastra Gotaland Region

Status and phase: Enrolling; Phase 2

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

Treatments: Biological: Late post-transplant vaccination with Gardasil 9®; Biological: Early start post-transplant vaccination with Gardasil 9®

Study type: Interventional

Funder types: Other

Identifiers

NCT06793410

ALLO-HPV

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Late vaccination group

Active Comparator group

Description:

Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.

Treatment:

Biological: Late post-transplant vaccination with Gardasil 9®

Early vaccination group

Experimental group

Description:

Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after stem cell transplantation.

Treatment:

Biological: Early start post-transplant vaccination with Gardasil 9®