HPV vaccination after allogeneic stem cell transplant
Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | rituximab, ruxolitinib, prednisone |
| Locations | 5 sites (Lund, Region Skåne and 4 other locations) |
| Trial ID | NCT06793410 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lund, Region Skåne and 4 other locations
- Skåne's University Hospital — Lund, Region Skåne, Sweden (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Region Stockholm, Sweden (Not_yet_recruiting)
- 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)
Study contacts
- Study coordinator: Sigrun Einarsdottir, MD, PhD
- Email: sigrun.einarsdottir@vgregion.se
- Phone: 0046313427358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.