Our aim is to determine whether an additional dose of inactivated vaccine can increase the rate of responders among patients who have not responded adequately after 3 injections MedDRA version: 20.0 Level: LLT Classification code 10067859 Term: Allogenic stem cell transplantation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Infanrix Hexa®
Product Name: Infanrix Hexa
Pharmaceutical Form: Powder and suspension for suspension for injection
Sponsors
University Hospital Grenoble
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age greater than or equal to 18 years - Realization of an allograft of haematopoietic stem cells at least 6 months, and at the most 24 months before inclusion - Discontinuation of immunosuppressive therapy for at least 3 months - Absence of GVH superior to grade I at the initiation of vaccination - 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant, parturient or nursing women - Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, subject to administrative or judicial supervision - Patients who received supplementation in the last 3 months with multivalent immunoglobulins, or for whom this treatment is planned - Contra-indication to Infanrix hexa® (hypersensitivity during an earlier injection) - Fever (=38 ° C) during consultation (delays inclusion at 1 week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the case of an unsatisfactory response after 3 doses (M0-M1-M2), determine in the AG-CSH recipients whether an additional dose to M4 of diphtheria-tetanus-poliomyelitis-H.influenzae-HBV vaccine (Hexavalent vaccine also including pertussis valency) improves the M13 vaccine response (1 month after M12 vaccine booster).;Secondary Objective: To determine the rate of responders against each of the 5 pathogens / infections 1 month after the 1 - year vaccine recall (at M13), by studying the impact of different patient - specific data (type of graft, type of conditioning, A GVH before vaccination ...) and the link between the response to M3 and that to M13.;Primary end point(s): M13 vaccine response rate in patients with an unsatisfactory response at M3 (comparison between supplemented and non-supplemented groups and with the M3 responder group). The vaccine response will be characterized by the following criteria: - unsatisfactory response: protective antibodies against less than 4 infections / pathogens among diphtheria, tetanus, poliomyelitis, HBV, and H. influenzae b - satisfactory response: protective antibodies against at least 4 of these infections / pathogens;Timepoint(s) of evaluation of this end point: 13 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Acquisition 1 month after vaccine recall at 1 year of a protective level of antibodies against the following pathogens / infections: diphtheria-tetanus-polyomyelitis- H.influenzae-HBV;Timepoint(s) of evaluation of this end point: M13 | — |
Countries
France
Contacts
Public ContactPr Olivier EPAULARD
University Hospital Grenoble
Outcome results
None listed