NCT06793410RecruitingPhase 2
Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- 12 May 2025
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Vastra Gotaland Region
- NCT number
- NCT06793410
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 12 May 2025 to the primary completion date, 31 Oct 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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
Other illness
- Allergy against Gardasil 9
Other
- Severe thrombocytopenia (under 50 x 10\^9) not allowing intramuscular injection
- Severe acute GvHD grade III-IV.
- Prednisone doses above 1mg/kg/day at study start.
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Skåne's University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.