NCT06793410 Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
| NCT ID | NCT06793410 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vastra Gotaland Region |
| Condition | Recipients of Allogeneic Stem Cell Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-05-12 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06793410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Recipients of Allogeneic Stem Cell Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06793410 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06793410 currently recruiting?
Yes, NCT06793410 is actively recruiting participants. Contact the research team at sigrun.einarsdottir@vgregion.se for enrollment information.
Where is the NCT06793410 trial being conducted?
This trial is being conducted at Lund, Sweden, Stockholm, Sweden, Uppsala, Sweden, Linköping, Sweden and 1 additional location.
Who is sponsoring the NCT06793410 clinical trial?
NCT06793410 is sponsored by Vastra Gotaland Region. The trial plans to enroll 100 participants.