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

RecruitingPhase 2Ages 18 Years - 45 YearsAllVastra Gotaland Region
NCT06793410 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 va

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📋 Eligibility rules (as published)
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
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What it tests

  • Early start post-transplant vaccination with Gardasil 9®
  • Late post-transplant vaccination with Gardasil 9®
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Where

5 sites
Skåne's University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Linköping University Hospital
Linköping, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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