HPV vaccination after allogeneic stem cell transplant
Official title: Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation
Run by Vastra Gotaland Region · NCT06793410 · Data updated 2026-11-12
This trial will test whether giving the 9‑valent HPV vaccine early or later after an allogeneic stem cell transplant produces a protective antibody response in adults up to age 45 who had a transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | rituximab, ruxolitinib, prednisone |
| Locations | 5 sites (Lund, Region Skåne and 4 other locations) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | October 31, 2029 |
| Study ends | October 31, 2029 |
| Registry record updated | June 5, 2025 |
| Trial ID | NCT06793410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–45 who received an allogeneic stem cell transplant, are medically stable without severe acute or extensive chronic GVHD or high‑dose steroids, and can attend one of the participating Swedish centers.
✕Probably not a fit
Patients with severe thrombocytopenia, grade III–IV acute GVHD, extensive chronic GVHD requiring multiple systemic therapies, recent rituximab or recent IV/SC immunoglobulin, or pregnancy are excluded and unlikely to benefit from the vaccine during the study period.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–45 who have received an allogeneic stem cell transplant are enrolled and receive the 9‑valent HPV vaccine (Gardasil 9) either early or later after transplantation. The main outcome is the antigen‑specific antibody response measured after the vaccine series to compare immune recovery by timing. Key exclusion criteria include severe thrombocytopenia, grade III–IV acute GVHD, extensive chronic GVHD on multiple systemic therapies, recent rituximab or recent IV/SC immunoglobulin, and pregnancy. The multicenter trial is conducted at three Swedish university hospitals and follows participants through the vaccination schedule and antibody testing.
Why it matters
Potential benefit: If successful, the results could identify the best timing for HPV vaccination after transplant to restore protection and reduce future HPV‑related cancers.
How similar studies have gone: Vaccination after hematopoietic stem cell transplant has restored immunity for some vaccines in prior work, but data specifically on HPV vaccine timing and effectiveness post‑transplant are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Uppsala University Hospital
Uppsala, Region Uppsala, Sweden Recruiting -
Linköping University Hospital
Linköping, Region Östergötaland, Sweden Recruiting -
Sahlgrenska University Hospital
Gothenburg, Västra Götalands Region, Sweden Recruiting -
Skåne's University Hospital
Lund, Region Skåne, Sweden Not yet recruiting -
Karolinska University Hospital
Stockholm, Region Stockholm, Sweden Not yet recruiting
Study contacts
- Study coordinator: Sigrun Einarsdottir, MD, PhD
- Email: sigrun.einarsdottir@vgregion.se
- Phone: 0046313427358
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.