Clinical trial NCT06793410: Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
Official title: Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recipients of Allogeneic Stem Cell Transplantation
HPV (Human Papillomavirus)-Associated
Acute Myeloid Leukaemia
Myelodysplastic Syndrome
Diffuse Large B Cell Lymphoma (DLBCL)
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2025-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Treatment with rituximab 6 months before start of vaccination. Doses given later (unusual) do not require exclusion.
* Treatment within 3 months before start of vaccination with iv or sc immunoglobulin.
* Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose.
* Treatment with blood thinning medication contraindicating intramuscular injection
* Allergy against Gardasil 9

Primary outcomes:
measure: Primary outcome - GMT level against HPV 16
timeFrame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary outcomes:
measure: Secondary outcome 1 - GMT level against all 9 HPV-serotypes
timeFrame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
measure: Secondary Outcome 2 - GMT level against all 9 HPV-serotypes
timeFrame: Early group: at month 27 posttransplant. Late group: at month 33 posttransplant.
measure: Secondary Outcome 3 - Proportion seropositive/negative against 9 HPV-serotypes
timeFrame: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.
measure: Secondary Outcome 4 - Seroconversion against 9 HPV-serotypes
timeFrame: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
measure: Secondary Outcome 5 - Proportion seropositive against 7/9 HPV-types
timeFrame: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne's University Hospital
state: Region Skåne
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Region Stockholm
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Region Uppsala
city: Linköping
country: Sweden
facility: Linköping University Hospital
state: Region Östergötaland
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götalands Region
Study officials:
References: