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.
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
Severe thrombocytopenia (under 50 x 10^9) not allowing intramuscular injection
Severe acute GvHD grade III-IV.
Extensive chronic GvHD requiring treatment with prednisone doses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photopheresis).
Prednisone doses above 1mg/kg/day at study start.
Parallel
Early start post-transplant vaccination with Gardasil 9®
Biological/VaccineSubjects 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®
Biological/VaccineSubjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.
Primary 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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
