Allogeneic hematopoietic stem cell recipients
Conditions
Interventions
Trade Name: Alpharix-Tetra
Pharmaceutical Form: Suspension for suspension for injection
INN or Proposed INN: A/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019, IVR-215)
Other descript
Sponsors
CHU de Liège
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type except cord blood transplantation); patients > 5 years are also eligible if they are still on systemic immunosuppressive treatment for chronic GVHD. - age> or = 18 years at inclusion. - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - HIV seropositivity - Pregnancy - Active malignant disease - Current grade III-IV acute GVHD - In vitro T-cell depletion of the graft if vaccination within 6 months after transplantation. - Rituximab administration in the 6 months prior to inclusion - IVIg in the 3 months before vaccination. - Prior post-transplant IIV vaccination in the 9 months prior inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aim is to better understand the mechanisms of serological and cellular responses to the IIV vaccine in allo-HCT patients and to decipher potential causes of non response in order to develop better vaccines / vaccine schedules for this study population. ;Secondary Objective: A secondary aim will be to compare the immune response associated with the first and the second dose of the vaccine. •To assess the impact of each vaccine injection on cytokine levels, transcriptomics and white blood cell sub-populations. •To compare changes observed after the first and the second vaccine injection •To assess whether changes in immune parameters from baseline to day 1 or 7 predict serological and cellular responses. •To assess the persistence of immune responses from day 49 to day 180 after first vaccination. ;Primary end point(s): There are two co-primary endpoints First co-primary endpoint The first primary endpoint is to use systems biology tools to identify baseline predictors of serological responses (complete and partial seroprotection ) to the vaccines at day 49. Second co-primary endpoint The second co-primary endpoint is to compare serological and cellular response following one and two doses of the vaccine (day 21 versus day 49). ;Timepoint(s) of evaluation of this end point: day 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess the impact of each vaccine injection on cytokine levels, transcriptomics and white blood cell sub-populations. • To compare changes observed after the first and the second vaccine injection • To assess whether changes in immune parameters from baseline to day 1 or 7 predict serological and cellular responses. • To assess the persistence of immune responses from day 49 to day 180 after first vaccination. ;Timepoint(s) of evaluation of this end point: day 180 | — |
Countries
Belgium
Contacts
Public ContactClinical Trials Information
CHU de Liège
Outcome results
None listed