Splenectomized Patients | Multicenter Pilot Study Evaluating the Immunogenicity of an Innovative Pneumococcal Vaccination Strategy in Splenectomized Adults
Splenectomized Patients research study
What is the primary objective of this study?
Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months. The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes common to the PCV and PPSV vaccines, selected because of their frequency in invasive infections in adults in France and their potentially reduced susceptibility to penicillin (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).
Who is eligible to participate?
Inclusion Criteria: - Age ≥ 18 years and ≤ 75 years - Splenectomized since at least 2 weeks, with Howell-Jolly bodies on a blood smear and ultrasonographic confirmation - No immunosppressived conditions : mainly trauma , idiopathic thrombocytopathic purpura or autoimmune hemolytic anemia, with no active treatment - Available for 37 months of follow-up starting from the screening visit - Contraception that the investigator judges effective for the first 2 months of the trial, with a negative pregnancy test - Women not planning to become pregnant in the 6 months following inclusion (M0) - Signed informed consent Exclusion Criteria: - Pregnancy or planned pregnancy in the 2 months following inclusion (M0) - Pathology or conditions which modify immune response (excluding splenectomy) : HIV infection, immunosuppressive therapy ongoing or in 6 months before inclusion (M0), including corticosteroids > 10 mg daily, topic inhaled or dermic corticoid treatments are allowed, hematopoietic stem cell allo / autograft, primary immune deficiency, nephrotic syndrome, sickle cell disease, evolutive neoplasia - History of anaphylactic reaction following vaccination - Known allergy to any of the ingredients of the vaccines: aluminium phosphate, phenol, Corynebacterium diphtheriae CRM-197 protein - Previous vaccination with 7-valent or 13-valent pneumococcal conjugate vaccine (in the 5 last years) - Previous vaccination with the pneumococcal polysaccharidic vaccine in the 3 years before inclusion (M0) - Other vaccination in the month before inclusion (M0) - Polyvalent immunoglobulin infusion in the 3 months before inclusion (M0) or during the planned duration of the study - Anticoagulant treatment current or stopped less than 7 days before inclusion (M0); or clotting disorder contra-indicating intramuscular injection - Participation to an other vaccine study in the 28 days before inclusion till the end of study - Not covered by national health insurance (beneficiary or assignee)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:Prime-boost pneumococcal immunization2 months between the 2 vaccines
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Prime-boost pneumococcal immunization
Active, not recruiting
Start Date: March 10, 2014
Completed Date: April 2019
Phase: Phase 2
Primary Outcome: Proportion of subjects responsive to 9 of the 13 serotypes common (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).
Secondary Outcome: IgG dosage
Study sponsors, principal investigator, and references
Principal Investigator: Hélène COIGNARD-BIEHLER, MD
Lead Sponsor: Assistance Publique - Hôpitaux de Paris