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RECRUITING
NCT06793410
PHASE2

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

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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