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NCT Number: NCT06793410

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

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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Key information

Conditions

Recipients of Allogeneic Stem Cell Transplantation Acute Myeloid Leukaemia Bone Marrow Diseases Communicable Diseases DNA Virus Infections Diffuse Large B Cell Lymphoma (DLBCL) Disease Attributes Genital Diseases HPV (Human Papillomavirus)-Associated Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skåne's University Hospital, Lund, Region Skåne, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary outcome - GMT level against HPV 16

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

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

Secondary outcomes

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

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

    Antibody level (GMT - geometric mean titer) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured 1 month after the third vaccine dose. Early vs late.

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

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

    Antibody level (GMT - geometric mean titer) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured at 12 months after the third vaccine dose. Early vs late.

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

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

    Proportion seropositive/negative against 9 HPV-serotypes included in vaccine measured 1 and 12 months after third dose. Early vs late.

  4. Secondary Outcome 4 - Seroconversion against 9 HPV-serotypes

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

    Seroconversion against 9 HPV-serotypes included in vaccine, pre-vaccination compared to 1 month after third dose, early vs late.

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

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

    Proportion seropositive against 7/9 HPV-types included in the vaccine at 1 and 12 months after completion of vaccination. Early vs late.

Study contacts

Contact information is provided by the study sponsor or research team.

Sigrun Einarsdottir, MD, PhD

CONTACT

[email protected]

0046313427358

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 27, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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