E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allogeneic hematopoietic stem cell recipients |
Receveurs d'une allogreffe de cellules souches hématopoïétiques |
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E.1.1.1 | Medical condition in easily understood language |
Allogeneic hematopoietic stem cell transplantation recipients |
Receveurs d'une allogreffe de cellules souches hématopoïétiques |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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when the database is cleaned and frozen |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |