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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Linköping University Hospital
RECRUITING
Linköping
Skåne's University Hospital
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Sigrun Einarsdottir, MD, PhD
sigrun.einarsdottir@vgregion.se
0046313427358
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Late vaccination group
Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.
Experimental: Early vaccination group
Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after stem cell transplantation.
Sponsors
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov