Actively Recruiting
Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
Led by Vastra Gotaland Region · Updated on 2025-06-05
100
Participants Needed
5
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipient of allogeneic stem cell transplantation from a related or unrelated donor
- Adults (men and women) aged 18 years up to and including 45 years for vaccination
- Patients may have received prior HPV vaccination before transplantation
You will not qualify if you...
- Severe thrombocytopenia (platelet count under 50 x 10^9) preventing intramuscular injection
- Severe acute graft-versus-host disease (GvHD) grade III-IV
- Extensive chronic GvHD requiring prednisone doses above 0.7 mg/kg/day plus at least two other systemic treatments
- Prednisone doses above 1 mg/kg/day at study start
- Rituximab treatment within 6 months before vaccination start
- Immunoglobulin treatment within 3 months before vaccination start
- Pregnancy, desire for pregnancy, or active pregnancy planning during vaccination and up to 3 months after last dose
- Treatment with blood thinners that prevent intramuscular injection
- Allergy to Gardasil 9 vaccine
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Skåne's University Hospital
Lund, Region Skåne, Sweden, 22242
Not Yet Recruiting
2
Karolinska University Hospital
Stockholm, Region Stockholm, Sweden, 17176
Not Yet Recruiting
3
Uppsala University Hospital
Uppsala, Region Uppsala, Sweden, 75185
Actively Recruiting
4
Linköping University Hospital
Linköping, Region Östergötaland, Sweden, 58185
Actively Recruiting
5
Sahlgrenska University Hospital
Gothenburg, Västra Götalands Region, Sweden, 41345
Actively Recruiting
Research Team
S
Sigrun Einarsdottir, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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