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

NCT ID: NCT06793410

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2029-10-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Late vaccination group

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

Group Type: ACTIVE_COMPARATOR

Late post-transplant vaccination with Gardasil 9®

Intervention Type: BIOLOGICAL

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

Early vaccination group

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

Group Type: EXPERIMENTAL

Early start post-transplant vaccination with Gardasil 9®

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skåne's University Hospital

Lund, Region Skåne, Sweden

Site Status: NOT_YET_RECRUITING

Karolinska University Hospital

Stockholm, Region Stockholm, Sweden

Site Status: NOT_YET_RECRUITING

Uppsala University Hospital

Uppsala, Region Uppsala, Sweden

Site Status: RECRUITING

Linköping University Hospital

Linköping, Region Östergötaland, Sweden

Site Status: RECRUITING

Sahlgrenska University Hospital

Gothenburg, Västra Götalands Region, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Sigrun Einarsdottir, MD, PhD

Role: CONTACT

sigrun.einarsdottir@vgregion.se

0046313427358

Facility Contacts

Stina Wichert, MD

Role: primary

Stina.Wichert@skane.se

004646-17 10 00

Anna Nordlander, MD

Role: primary

anna.nordlander@regionstockholm.se

00468-123 700 00

Tobias Tolf, MD

Role: primary

tobias.tolf@akademiska.se

004618-611 00 00

Thomas Erger, MD

Role: primary

Thomas.Erger@regionostergotland.se

004610-103 00 00

Sigrun Einarsdottir, MD, PhD

Role: primary

sigrun.einarsdottir@vgregion.se

0046313427358

Other Identifiers

ALLO-HPV

Identifier Type: -

Identifier Source: org_study_id