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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after transplantation.
Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.
Skåne's University Hospital
Lund, Region Skåne, Sweden
NOT_YET_RECRUITINGKarolinska University Hospital
Stockholm, Region Stockholm, Sweden
NOT_YET_RECRUITINGUppsala University Hospital
Uppsala, Region Uppsala, Sweden
RECRUITINGLinköping University Hospital
Linköping, Region Östergötaland, Sweden
RECRUITINGSahlgrenska University Hospital
Gothenburg, Västra Götalands Region, Sweden
RECRUITINGPrimary outcome - GMT level against HPV 16
Antibody level (GMT - geometric mean titer) against HPV 16 measured 1 months after the third vaccine dose, early vs late.
Time frame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary outcome 1 - GMT level against all 9 HPV-serotypes
Antibody level (GMT - geometric mean titer) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured 1 month after the third vaccine dose. Early vs late.
Time frame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary Outcome 2 - GMT level against all 9 HPV-serotypes
Antibody level (GMT - geometric mean titer) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured at 12 months after the third vaccine dose. Early vs late.
Time frame: Early group: at month 27 posttransplant. Late group: at month 33 posttransplant.
Secondary Outcome 3 - Proportion seropositive/negative against 9 HPV-serotypes
Proportion seropositive/negative against 9 HPV-serotypes included in vaccine measured 1 and 12 months after third dose. Early vs late.
Time frame: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.
Secondary Outcome 4 - Seroconversion against 9 HPV-serotypes
Seroconversion against 9 HPV-serotypes included in vaccine, pre-vaccination compared to 1 month after third dose, early vs late.
Time frame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary Outcome 5 - Proportion seropositive against 7/9 HPV-types
Proportion seropositive against 7/9 HPV-types included in the vaccine at 1 and 12 months after completion of vaccination. Early vs late.
Time frame: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.
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