Immune response to pneumococcal vaccination in patients after community acquired pneumonia with Streptococcus pneumoniae MedDRA version: 16.0 Level: LLT Classification code 10071915 Term: Vaccination site bleeding System Organ Class: 100000004867 MedDRA version: 16.0 Level: LLT Classification code 10046860 Term: Vaccination adverse reaction System Organ Class: 100000004863 MedDRA version: 16.0 Level: LLT Classification code 10069488 Term: Vaccination site paresthesia System Organ Class: 10000
Conditions
Interventions
Trade Name: Prevenar 13
Product Name: Prevenar 13
Pharmaceutical Form: Injection
Sponsors
Sint Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who participated in the Ovidius or Triple-P study (2004-2009). 2. Diagnosis in these studies with pneumococcal pneumonia or pneumonia due other identified organism. 3. Age = 18 years. 4. Signing of 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Diagnosis of pneumonia without an identified causative organism. 2. Fever at time of vaccination. 3. Previous/known allergic reaction to any of the components of the vaccine given. 4. Mentally incompetent. 5. Previous pneumococcal vaccination* * with exception of patients displaying a persistent defect in the serotype specific immune response after vaccination with the polysaccharide-based vaccine Pneumovax 23. Possibly this specific serotype defect will be ‘’repaired’’ after vaccination with the (more potent) conjugate vaccine Prevnar 13.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past;Secondary Objective: To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past who failed to elicit a specific antibody response previously. To investigate the cellular immune responses after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past. To investigate quality of life by the RAND-36 score in patients with a community acquired pneumonia in the past. To investigate the long-term mortality after community acquired pneumococcal pneumonia. ;Primary end point(s): Antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past. Parameters are: • Antibody titers against 13 different serotypes of S. pneumoniae before and after vaccination. Patients will be classified in overall / serotype specific response. • Avidity maturation against 13 different serotypes of S. pneumoniae will be calculated with relative avidity index (RAI). ;Timepoint(s) of evaluation of this end point: 3-4 weeks after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Antibody response after pneumococcal vaccination in subset of patients with community acquired pneumococcal pneumonia in the past who failed to elicit a specific antibody response previously. • Immunoglobulin levels and subclasses. • Lymphocyte subsets (number of B cells, CD3, CD4, CD8 and NK cells). • Cellular immune responses. • Quality of life (RAND-36). • Long-term mortality after community acquired pneumococcal pneumonia. ;Timepoint(s) of evaluation of this end point: 3-4 weeks after vaccination | — |
Countries
Netherlands
Contacts
Public ContactResearch & Development
Sint Antonius Hospital
Outcome results
None listed