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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
Sponsor:
Information provided by (Responsible Party):
Gertjan Wagenvoort, St. Antonius Hospital

Brief 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 compared to patients with CAP due another causative agent. 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.

Condition or disease Intervention/treatment Phase
Pneumonia Streptococcus Pneumoniae Immune Response Biological: Prevnar 13 Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Prevnar 13
Prevnar 13, 1 administration of 1 single dose (0.5mL)
Biological: Prevnar 13
Other Names:
  • Prevenar 13
  • pneumococcal 13-valent conjugate vaccin
  • PCV13




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 conjugate vaccination.
  6. Pneumococcal polysaccharide vaccination within 6 months prior to inclusion.
  7. Clinical pneumonia within 1 month prior to inclusion.

Information from the National Library of Medicine

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


Locations
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Netherlands
St. Antonius Hospital Nieuwegein
Nieuwegein, Utrecht, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gertjan Wagenvoort, MD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02141009     History of Changes
Other Study ID Numbers: NL44924.100.13
2013-002166-39 ( EudraCT Number )
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Gertjan Wagenvoort, St. Antonius Hospital:
Vaccination, prevnar, PCV13
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs