Recipients of Allogeneic Stem Cell TransplantationPhase 2NCT06793410
Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation
A Phase 2 study testing Early start post-transplant vaccination with Gardasil 9® and Late post-transplant vaccination with Gardasil 9® in people with Recipients of Allogeneic Stem Cell Transplantation and HPV (Human Papillomavirus)-Associated, run by Vastra Gotaland Region at 5 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Recipients of Allogeneic Stem Cell Transplantation, HPV (Human Papillomavirus)-Associated, Acute Myeloid Leukaemia
- What is being tested?
- Early start post-transplant vaccination with Gardasil 9® and Late post-transplant vaccination with Gardasil 9®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesSweden
- Study dates
- 12 May 2025to 31 Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götalands Region, 41345
Sigrun Einarsdottir, MD, PhD, 0046313427358, sigrun.einarsdottir@vgregion.se
Sigrun Einarsdottir, MD, PhD
- Recruiting
Linköping University Hospital
Linköping, Region Östergötaland, 58185
Thomas Erger, MD, 004610-103 00 00, Thomas.Erger@regionostergotland.se
Thomas Erger, MD
- Not yet recruiting
Skåne's University Hospital
Lund, Region Skåne, 22242
Stina Wichert, MD, 004646-17 10 00, Stina.Wichert@skane.se
Stina Wichert, MD
- Not yet recruiting
Karolinska University Hospital
Stockholm, Region Stockholm, 17176
Anna Nordlander, MD, 00468-123 700 00, anna.nordlander@regionstockholm.se
Anna Nordlander, MD
- Recruiting
Uppsala University Hospital
Uppsala, Region Uppsala, 75185
Tobias Tolf, MD, 004618-611 00 00, tobias.tolf@akademiska.se
Tobias Tolf, MD
About this study
Official title: Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation
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.
- Conditions
- Recipients of Allogeneic Stem Cell Transplantation, HPV (Human Papillomavirus)-Associated, Acute Myeloid Leukaemia, Myelodysplastic Syndrome, Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- Early start post-transplant vaccination with Gardasil 9®, Late post-transplant vaccination with Gardasil 9®
- Medical subject headings
- Papillomavirus Infections, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early start post-transplant vaccination with Gardasil 9®Biological
Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after transplantation.
Late post-transplant vaccination with Gardasil 9®Biological
Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Late vaccination group | Active comparator | Subjects will receive Gardasil 9® as part of the late post-transplant vaccination, starting at 15 months after stem cell transplantation. Receives: Biological: Late post-transplant vaccination with Gardasil 9® |
| Early vaccination group | Experimental | Subjects will receive Gardasil 9® as part of the early post-transplant vaccination, starting at 9 months after stem cell transplantation. Receives: Biological: Early start post-transplant vaccination with Gardasil 9® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome - GMT level against HPV 16
Antibody level (GMT - geometric mean titer) against HPV 16 measured 1 months after the third vaccine dose, early vs late.
Measured: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary outcomes (5)
Secondary outcome 1 - GMT level against all 9 HPV-serotypes
Antibody level (GMT - geometric mean titer) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured 1 month after the third vaccine dose. Early vs late.
Measured: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary Outcome 2 - GMT level against all 9 HPV-serotypes
Antibody level (GMT - geometric mean titer) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured at 12 months after the third vaccine dose. Early vs late.
Measured: Early group: at month 27 posttransplant. Late group: at month 33 posttransplant.
Secondary Outcome 3 - Proportion seropositive/negative against 9 HPV-serotypes
Proportion seropositive/negative against 9 HPV-serotypes included in vaccine measured 1 and 12 months after third dose. Early vs late.
Measured: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.
Secondary Outcome 4 - Seroconversion against 9 HPV-serotypes
Seroconversion against 9 HPV-serotypes included in vaccine, pre-vaccination compared to 1 month after third dose, early vs late.
Measured: Early group: at month 16 posttransplant. Late group: at month 22 posttransplant.
Secondary Outcome 5 - Proportion seropositive against 7/9 HPV-types
Proportion seropositive against 7/9 HPV-types included in the vaccine at 1 and 12 months after completion of vaccination. Early vs late.
Measured: Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start12 May 2025
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recipients of Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793410
- Sponsor's protocol ID
- ALLO-HPV
- Status last verified
- May 2025
- First submitted
- 13 Jan 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this clinical trial will not be publicly shared to protect participant privacy and confidentiality. However, researchers may contact the Principal Investigator to request access to de-identified data.