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

NCT06793410 | Recruiting Phase 2

• 1 other identifier: ALLO-HPV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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)

Outcome Measures

Primary Outcomes (1)

• Primary outcome - GMT level against HPV 16

  Antibody level (GMT - geometric mean titer) against HPV 16 measured 1 months after the third vaccine dose, early vs late.

  Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.

Secondary Outcomes (5)

• Secondary outcome 1 - GMT level against all 9 HPV-serotypes

  Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.

• Secondary Outcome 2 - GMT level against all 9 HPV-serotypes

  Early group: at month 27 posttransplant. Late group: at month 33 posttransplant.

• Secondary Outcome 3 - Proportion seropositive/negative against 9 HPV-serotypes

  Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.

• Secondary Outcome 4 - Seroconversion against 9 HPV-serotypes

  Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.

• Secondary Outcome 5 - Proportion seropositive against 7/9 HPV-types

  Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.

Study Arms (2)

Late vaccination group

ACTIVE COMPARATOR

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

Biological: Late post-transplant vaccination with Gardasil 9®

Early vaccination group

EXPERIMENTAL

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

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

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.

Early vaccination group

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.

Late vaccination group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (5)

Skåne's University Hospital

Lund, Region Skåne, 22242, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Region Stockholm, 17176, Sweden

NOT YET RECRUITING

Uppsala University Hospital

Uppsala, Region Uppsala, 75185, Sweden

RECRUITING

Linköping University Hospital

Linköping, Region Östergötaland, 58185, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Västra Götalands Region, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Lymphoma, Large B-Cell, Diffuse

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sigrun Einarsdottir, MD, PhD

CONTACT

0046313427358; sigrun.einarsdottir@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 27, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)