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Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
Sponsor: Vastra Gotaland Region
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.
Official title: Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-05-12
Completion Date
2029-10-31
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
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.
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.
Locations (5)
Skåne's University Hospital
Lund, Region Skåne, Sweden
Karolinska University Hospital
Stockholm, Region Stockholm, Sweden
Uppsala University Hospital
Uppsala, Region Uppsala, Sweden
Linköping University Hospital
Linköping, Region Östergötaland, Sweden
Sahlgrenska University Hospital
Gothenburg, Västra Götalands Region, Sweden