Clinical trial • Phase II|Phase IV • Oncology|Infectious Disease
Human papillomavirus L1 proteins (types 6, 11, 16, 18, 31, 33, 45, 52, 58) for Recipients of allogeneic stem cell transplantation
Phase II|Phase IV trial of Human papillomavirus L1 proteins (types 6, 11, 16, 18, 31, 33, 45, 52, 58) for Recipients of allogeneic stem cell transplantati…
Overview
- Trial Therapeutic Area
- Oncology|Infectious Disease
- Trial Disease
- Recipients of allogeneic stem cell transplantation
- Trial Stage
- Phase II|Phase IV
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 25-04-2024
- First CTIS Authorization Date
- 19-07-2024
Trial design
Randomised, early vaccination starting at 9 months post-transplant vs late vaccination starting at 15 months post-transplant; both arms receive gardasil 9 suspension for injection (intramuscular, 0.5 ml per dose; three doses).-controlled Phase II|Phase IV trial across 5 sites in Sweden.
- Randomised
- Yes
- Comparator
- Early vaccination starting at 9 months post-transplant vs late vaccination starting at 15 months post-transplant; both arms receive Gardasil 9 suspension for injection (intramuscular, 0.5 ml per dose; three doses).
- Target Sample Size
- 100
Eligibility
Recruits 100 No vulnerable population selected (isVulnerablePopulationSelected=false); participants are adults (>=18 years). No assent procedures or additional vulnerable-consent handling described..
- Pregnancy Exclusion
- Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false); participants are adults (>=18 years). No assent procedures or additional vulnerable-consent handling described.
Inclusion criteria
- {"criterion_text":"- Recipient of AlloSCT from related or unrelated donor."}
- {"criterion_text":"- Adults (men and women) ≥18 years up to and including 55 years of age for vaccination."}
- {"criterion_text":"- Patients can be included regardless of prior HPV vaccination prior to transplantation"}
Exclusion criteria
- {"criterion_text":"- Severe thromobocytopenia (under 50 x 10^9) not allowing intramuscular injektion"}
- {"criterion_text":"- Severe acute GvHD grade III-IV."}
- {"criterion_text":"- 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)."}
- {"criterion_text":"- Prednisonedoses above 1mg/kg/dag at studystart."}
- {"criterion_text":"- Treatment with rituximab 6 months before start of vaccination. Doses given later (unusual) do not require exclusion."}
- {"criterion_text":"- Treatment within 3 months before start of vaccination with iv or sc immunoglobulin."}
- {"criterion_text":"- Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose."}
- {"criterion_text":"- Treatment with blodthinning medication contraindicating intramuscular injection"}
- {"criterion_text":"- Allergy against Gardasil 9"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Antibody level (GMT) against HPV 16 measured 1 months after the third vaccine dose, early vs late","definition_or_measurement_approach":"Geometric mean titre (GMT) of anti-HPV16 antibodies measured 1 month after the third vaccine dose; comparison between early and late vaccination groups."}
Secondary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Geometric mean titre (GMT) of antibodies against the nine vaccine HPV serotypes measured 1 month after the third vaccine dose; early vs late comparison."}
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Geometric mean titre (GMT) measured 12 months after the third vaccine dose for the nine HPV serotypes; early vs late comparison."}
- {"endpoint_text":"- Proportion seropositive/negative against 9 HPV-serotypes included in vaccine measured 1 and 12 months after third dose. Early vs late.","definition_or_measurement_approach":"Proportion of participants seropositive vs seronegative for each of the nine HPV serotypes at 1 and 12 months after the third dose; comparison early vs late."}
- {"endpoint_text":"- Seroconversion against 9 HPV-serotypes included in vaccine, prevaccination compared to 1 month after third dose, early vs late.","definition_or_measurement_approach":"Seroconversion rates for the nine HPV serotypes comparing pre-vaccination status to 1 month after the third dose; early vs late groups."}
- {"endpoint_text":"- Proportion seropositive against 7/9 HPV-types included in the vaccine at 1 and 12 months after completion of vaccination. Early vs late.","definition_or_measurement_approach":"Proportion of participants seropositive for 7 of 9 HPV types at 1 and 12 months after completion of vaccination; early vs late comparison."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 51
- Consent Approach
- Subject information and informed consent form provided (document: L1_Forsokspersonsinformation_samtycke). Consent to be provided by the participant; no assent procedures or additional consent-for-vulnerable-populations details described.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 100
Sweden
- Earliest CTIS Part Ii Submission Date
- 30-06-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 662
- Number Of Sites
- 5
- Number Of Participants
- 100
Sites
- Site Name
- Sahlgrenska University Hospital-Vastra Gotalandsregionen
- Department Name
- Hematology Department
- Contact Person Name
- Sigrun Einarsdottir
- Contact Person Email
- sigrun.einarsdottir@vgregion.se
- Site Name
- Linkoping University Hospital Region Ostergotland
- Department Name
- Hematology Department
- Contact Person Name
- Thomas Erger
- Contact Person Email
- region@regionostergotland.se
- Site Name
- Uppsala University Hospital
- Department Name
- Hematology Department
- Contact Person Name
- Tobias Tolf
- Contact Person Email
- tobias.tolf@akademiska.se
- Site Name
- Karolinska University Hospital
- Department Name
- CAST
- Contact Person Name
- Anna Nordlander
- Contact Person Email
- anna.nordlander@regionstockholm.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematology Department
- Contact Person Name
- Stina Wichert
- Contact Person Email
- stina.wichert@skane.se
Sponsor
Primary sponsor
- Full Name
- Vastra Gotalandsregionen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Gardasil 9 suspension for injection. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
- Active Substance
- Human papillomavirus L1 proteins (types 6, 11, 16, 18, 31, 33, 45, 52, 58)
- Modality
- Vaccine
- Routes Of Administration
- INTRAMUSCULAR
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation EU/1/15/1007/001)
- Starting Dose
- 0.5 ml
- Frequency
- Three doses (schedule not specified in documents provided)
- Maximum Dose
- Max daily 0.5 ml; max total amount reported as 3 ml
Related trials
Other published trials that may interest you.