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Immune response against pneumococcal vaccination in patients after pneumonia


- candidate number16701
- NTR NumberNTR4460
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-mrt-2014
- Secondary IDsNL44924.100.13 
- Public TitleImmune response against pneumococcal vaccination in patients after pneumonia
- Scientific TitleCommunity Acquired Pneumonia: Outcome, Quality of Life and Immune Status
- ACRONYMCAPolista
- hypothesisThe immune response to pneumococcal vaccination in patients after community acquired pneumonia with S. pneumoniae is different compared to pneumonia patients with another pathogen.
- Healt Condition(s) or Problem(s) studiedImmune respons, Pneumococcal vaccination, Pneumococcal conjugate vaccination, Pneumonia
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2015
- Target number of participants140
- Interventions13-valent pneumococcal conjugate vaccination, prevenar 13 (PCV13)
- Primary outcomeImmune 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.
- Timepoints1) Week 1, first blood draw, vaccination, RAND36. 2) After 3-4 weeks, second blood draw.
- Trial web sitenone
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES G. Wagenvoort
- CONTACT for SCIENTIFIC QUERIES G. Wagenvoort
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- Publications
- Brief summary
- Main changes (audit trail)2-sept-2014: Exclusion criteria changed:
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 conjugate vaccination.
6. Pneumococcal polysaccharide vaccination within 6 months prior to inclusion.
7. Clinical pneumonia within 1 month prior to inclusion.
- AB
- RECORD7-mrt-2014 - 31-mei-2015


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