Community Acquired Pneumonia: Outcome, Quality of Life and Immune Status (CAPolista)
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|ClinicalTrials.gov Identifier: NCT02141009|
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Streptococcus Pneumoniae Immune Response||Biological: Prevnar 13||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Response to Pneumococcal Vaccination in Patients After Community Acquired Pneumonia With Streptococcus Pneumoniae Compared to Pneumonia Patients With Another Pathogen.|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Prevnar 13, 1 administration of 1 single dose (0.5mL)
Biological: Prevnar 13
- Antibody titers against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F [ Time Frame: Change in antibody titers week 1 and week 3-4 ]
Antibody titers against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and avidity maturation will be determined using Luminex technology.
A serotype specific response to vaccination is defined as a ≥ 2-4-fold increase in serum antibody titre from baseline (and a post vaccination titer > 0.35 µg/mL) or a post immunization titer ≥ 1.3 ug/mL
- Antibody avidity maturation against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F [ Time Frame: Change in avidity between week 1 and week 3-4 ]
Antibody avidity maturation against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F will be determined using Luminex technology in combination with a chaotropic agent.
The avidity maturation will be calculated with relative avidity index (RAI) in percent based on baseline and post vaccination measurements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141009
|St. Antonius Hospital Nieuwegein|
|Nieuwegein, Utrecht, Netherlands, 3430 EM|
|Study Director:||Ger T Rijkers, Prof||St. Antonius Hospital|
|Principal Investigator:||Gertjan H Wagenvoort, MD||St. Antonius Hospital|
|Principal Investigator:||Bart JM Vlaminckx, Phd||St. Antonius Hospital|