The aim of this study is to investigate immune response to pneumococcal vaccination in patients after community acquired pneumonia with S. pneumoniae compared to pneumonia patients with another pathogen.
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Immune response to pneumococcal vaccination in patients who were diagnosed with
CAP due to S. pneumoniae in comparison with patients with another causative
pathogen. Main parameters are antibody titres against the different
pneumococcal serotypes before and after vaccination and avidity maturation of
these antibodies.
Secondary outcome
* 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 compared
to pneumonia patients with another pathogen..
* 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.
Background summary
Community acquired pneumonia (CAP) is an important health problem with
significant morbidity, mortality and cost. The most identified pathogen in CAP
is Streptococcus pneumoniae. This was also the causative agent most frequently
found in the Ovidius and Triple-P study, two consecutive clinical trials
initiated by the St. Antonius Hospital Nieuwegein. Diagnosis of pneumococcal
pneumonia can be based on positive blood cultures, sputum cultures, urine
antigen testing or a serotype specific antibody response. When pneumococcal
pneumonia is diagnosed by a positive culture, a matching serotype specific
antibody response is expected. However not all patients in the Ovidius and
Triple-P study with a culture proven pneumococcal pneumonia showed an antibody
response against the infecting pneumococcal serotype.
Patients who survived pneumococcal pneumonia are considered as a high-risk
population for pneumococcal disease in the future. Possibly these patients have
an impaired immune response against S. pneumoniae. In this study, pneumococcal
vaccination of patients with S. pneumoniae CAP in the past enables
investigating their immune response after vaccination. Furthermore this study
provides information to determine if there is a difference in vaccination
response between pneumococcal pneumonia patients who had a culture matching
serotype specific antibody response and between pneumococcal pneumonia patients
who failed to elicit this response previously. Possibly these latter patients
had a temporarily low titre due to the infection but another explanation is
that there might be a structurally impaired immune response against S.
pneumoniae or certain serotypes.
Study objective
The aim of this study is to investigate immune response to pneumococcal
vaccination in patients after community acquired pneumonia with S. pneumoniae
compared to pneumonia patients with another pathogen.
Study design
The design is a prospective cohort study with patients who were included in the
Ovidius or the Triple-P study and diagnosed with CAP due to S. pneumoniae. The
control group will consist of patients who were included in the same studies
but who were diagnosed with pneumonia with another pathogen.
Study burden and risks
Patients will be vaccinated with a pneumococcal vaccine Prevnar 13. Blood
samples will be drawn before the vaccination and three * four weeks after
vaccination; so two blood samples will be drawn. The study can only be done
using these patient groups because we want to investigate immune response to
pneumococcal vaccination in patients after community acquired pneumonia with S.
pneumoniae and compare these with immune responses at time of the CAP. The
vaccine will be used in the authorised form; therefore no additional risks are
to be expected. Only in very rare cases severe adverse events occur. Benefit is
possible protection against the encapsulated bacterium S. pneumoniae that is
known to cause serious infections.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
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 another identified organism.
3. Age * 18 years.
4. Signing of informed consent.
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.
6. Clinical pneumonia within 1 month prior to inclusion.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002166-39-NL |
| CCMO | NL44924.100.13 |
| OMON | NL-OMON21679 |