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Vaccination against human papillomavirus (HPV) after allogeneic stem cell transplantation, a randomized study between early and late vaccination.
EU CTIS ID: 2022-502912-35-00
What this study is testing
To compare vaccine responses to Gardasil 9® at early start post-transplant vaccination (start at 9 months) compared to late (15 months) after stem cell transplant.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Recipient of AlloSCT from related or unrelated donor.
- Adults (men and women) ≥18 years up to and including 55 years of age for vaccination.
- Patients can be included regardless of prior HPV vaccination prior to transplantation
You likely can't join if
- Severe thromobocytopenia (under 50 x 10^9) not allowing intramuscular injektion
- Severe acute GvHD grade III-IV.
- Extensive chronic GvHD requiring treatment with prednisonedoses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photoferesis).
- Prednisonedoses above 1mg/kg/dag at studystart.
- 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.
See the full eligibility criteria
- Recipient of AlloSCT from related or unrelated donor.
- Adults (men and women) ≥18 years up to and including 55 years of age for vaccination.
- Patients can be included regardless of prior HPV vaccination prior to transplantation
- Severe thromobocytopenia (under 50 x 10^9) not allowing intramuscular injektion
- Severe acute GvHD grade III-IV.
- Extensive chronic GvHD requiring treatment with prednisonedoses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photoferesis).
- Prednisonedoses above 1mg/kg/dag at studystart.
- 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 blodthinning medication contraindicating intramuscular injection
- Allergy against Gardasil 9
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.