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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Early group: at month 16 posttransplant. Late group: at month 22 posttransplant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Early group: at month 16 posttransplant. Late group: at month 22 posttransplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sigrun Einarsdottir, MD, PhD | Contact | 0046313427358 | sigrun.einarsdottir@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne's University Hospital | Not yet recruiting | Lund | Region Skåne | 22242 | Sweden |
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.
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| 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. |
|
| 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. |
| 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. | 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. | 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. | Early group: at month 16 and month 27 posttransplant. Late group: at month 22 and month 33 posttransplant. |
| Karolinska University Hospital | Not yet recruiting | Stockholm | Region Stockholm | 17176 | Sweden |
|
| Uppsala University Hospital | Recruiting | Uppsala | Region Uppsala | 75185 | Sweden |
|
| Linköping University Hospital | Recruiting | Linköping | Region Östergötaland | 58185 | Sweden |
|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Västra Götalands Region | 41345 | Sweden |
|
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
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