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New treatment option for Recipients of Allogeneic Stem Cell Transplantation
Official title Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06793410
What this study is testing
What is Early start post-transplant vaccination with Gardasil 9®?
Early start post-transplant vaccination with Gardasil 9® is an investigational medicine, being studied as a potential treatment for recipients of allogeneic stem cell transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
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 45 years of age for vaccination.
- Patients can be included regardless of prior HPV vaccination prior to transplantation
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Region Skåne, Sweden
- Stockholm, Region Stockholm, Sweden
- Uppsala, Region Uppsala, Sweden
- Linköping, Region Östergötaland, Sweden
- Gothenburg, Västra Götalands Region, Sweden
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 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Region Skåne, Sweden; Stockholm, Region Stockholm, Sweden; Uppsala, Region Uppsala, Sweden; Linköping, Region Östergötaland, Sweden; Gothenburg, Västra Götalands Region, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.