Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
5
Recipients of allogeneic stem cell transplantation
To compare vaccine responses to Gardasil 9® at early start post-transplant vaccination (start at 9 months) compared to late (15 months) after stem cell transplant.
Key facts
- Sponsor
- Vastra Gotalandsregionen
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 12 Mar 2025 → ongoing
- Decision date (initial)
- 2024-07-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To compare vaccine responses to Gardasil 9® at early start post-transplant vaccination (start at 9 months) compared to late (15 months) after stem cell transplant.
Secondary objectives 5
- Antibody level against all nine HPV-types in the vaccine 1 month after completion of vaccination, early vs late
- Antibody level against all nine HPV-types in the vaccine 12 months after completion of vaccination, early vs late
- Proportion seronegative/seropositive against the nine HPV-types in the vaccine at 1 and 12 months after completion of vaccination, early vs late
- Seroconversion against the nine HPV-types in the vaccine, prevaccination compared to 1 month after completion of vaccination, early vs late
- Proportion of seropositive against 7/9 serotypes in the vaccine at 1 and 12 months after completion of vaccination, early vs late
Conditions and MedDRA coding
Recipients of allogeneic stem cell transplantation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Recipient of AlloSCT from related or unrelated donor.
- Adults (men and women) ≥18 years up to and including 55 years of age for vaccination.
- Patients can be included regardless of prior HPV vaccination prior to transplantation
Exclusion criteria 9
- Severe thromobocytopenia (under 50 x 10^9) not allowing intramuscular injektion
- Severe acute GvHD grade III-IV.
- Extensive chronic GvHD requiring treatment with prednisonedoses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photoferesis).
- Prednisonedoses above 1mg/kg/dag at studystart.
- 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 blodthinning medication contraindicating intramuscular injection
- Allergy against Gardasil 9
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Antibody level (GMT) against HPV 16 measured 1 months after the third vaccine dose, early vs late
Secondary endpoints 5
- Antibody level (GMT) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured 1 month after the third vaccinedose. Early vs late.
- Antibody level (GMT) 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.
- Proportion seropositive/negative against 9 HPV-serotypes included in vaccine measured 1 and 12 months after third dose. Early vs late.
- Seroconversion against 9 HPV-serotypes included in vaccine, prevaccination compared to 1 month after third dose, early vs late.
- Proportion seropositive against 7/9 HPV-types included in the vaccine at 1 and 12 months after completion of vaccination. Early vs late.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Gardasil 9 suspension for injection. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
PRD4575515 · Product
- Active substance
- Human Papillomavirus Type 31 L1 Protein
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 3 ml millilitre(s)
- Max treatment duration
- 7 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BM03 — -
- Marketing authorisation
- EU/1/15/1007/001
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vastra Gotalandsregionen
- Sponsor organisation
- Vastra Gotalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vastra Gotalandsregionen
- Contact name
- Sigrun Einarsdottir
Public contact point
- Organisation
- Vastra Gotalandsregionen
- Contact name
- Sigrun Einarsdottir
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 100 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Karolinska University Hospital
CAST, Halsovagen, Flemingsberg, Huddinge
Uppsala University Hospital
Hematology Department, Akademiska Sjukhuset, 751 85, Uppsala
Region Skane Skanes Universitetssjukhus
Hematology Department, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Hematology Department, Bla Straket 5, 413 46, Goteborg
Linkoping University Hospital Region Ostergotland
Hematology Department, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2025-03-12 | 2025-05-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502912-35-00 | 1.7 |
| Protocol (for publication) | D1_Protocol_2022-502912-35-00_clean_version | 1.10 |
| Protocol (for publication) | D1_Protocol_2022-502912-35-00_tracked_changes | 1.10 |
| Recruitment arrangements (for publication) | K1_Rekryteringsforfarande_2022-502912-35-00 | 1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_samtycke_2022-502912-35-00 | 2 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_samtycke_2022-502912-35-00_clean_version | 3 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_samtycke_2022-502912-35-00_Tracked_changes | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Gardasil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Gardasil_03_10_26 | 2 |
| Synopsis of the protocol (for publication) | D2_Protocol_synopsis_2022-502912-35-00 | 3 |
| Synopsis of the protocol (for publication) | D2_Protocol_synopsis_2022-502912-35-00_tracked_changes | 3 |
| Synopsis of the protocol (for publication) | public_placeholder | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-25 | Sweden | Acceptable 2024-07-18
|
2024-07-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-11 | Sweden | Acceptable 2026-04-21
|
2026-04-23 |