Community Acquired Pneumonia: Outcome, Quality of Life and Immune Status

NCT02141009 | Completed Phase 4

• 2 other identifiers: NL44924.100.132013-002166-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Streptococcus Pneumoniae; Immune Response

Keywords

Vaccination, prevnar, PCV13

Outcome Measures

Primary Outcomes (1)

• Antibody titers against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

  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

  Change in antibody titers week 1 and week 3-4

Secondary Outcomes (1)

• Antibody avidity maturation against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

  Change in avidity between week 1 and week 3-4

Study Arms (1)

Prevnar 13

OTHER

Prevnar 13, 1 administration of 1 single dose (0.5mL)

Biological: Prevnar 13

Interventions

Prevnar 13 BIOLOGICAL

Also known as: Prevenar 13, pneumococcal 13-valent conjugate vaccin, PCV13

Prevnar 13

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who participated in the Ovidius or Triple-P study (2004-2009).
• Diagnosis in these studies with pneumococcal pneumonia or pneumonia due another identified organism.
• Age ≥ 18 years.
• Signing of informed consent.

You may not qualify if:

• Diagnosis of pneumonia without an identified causative organism.
• Fever at time of vaccination.
• Previous/known allergic reaction to any of the components of the vaccine given.
• Mentally incompetent.
• Previous pneumococcal conjugate vaccination.

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Hospital Nieuwegein

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

Related Publications (9)

• File TM. Community-acquired pneumonia. Lancet. 2003 Dec 13;362(9400):1991-2001. doi: 10.1016/S0140-6736(03)15021-0.

  PMID: 14683661 BACKGROUND

• Principi N, Esposito S. Use of the 13-valent pneumococcal conjugate vaccine in infants and young children. Expert Opin Biol Ther. 2012 May;12(5):641-8. doi: 10.1517/14712598.2012.670217. Epub 2012 Mar 7.

  PMID: 22397739 BACKGROUND

• van Mens SP, Meijvis SC, Endeman H, van Velzen-Blad H, Biesma DH, Grutters JC, Vlaminckx BJ, Rijkers GT. Longitudinal analysis of pneumococcal antibodies during community-acquired pneumonia reveals a much higher involvement of Streptococcus pneumoniae than estimated by conventional methods alone. Clin Vaccine Immunol. 2011 May;18(5):796-801. doi: 10.1128/CVI.00007-11. Epub 2011 Mar 2.

  PMID: 21367978 BACKGROUND

• Borrow R, Stanford E, Waight P, Helbert M, Balmer P, Warrington R, Slack M, George R, Miller E. Serotype-specific immune unresponsiveness to pneumococcal conjugate vaccine following invasive pneumococcal disease. Infect Immun. 2008 Nov;76(11):5305-9. doi: 10.1128/IAI.00796-08. Epub 2008 Sep 8.

  PMID: 18779338 BACKGROUND

• Endeman H, Meijvis SC, Rijkers GT, van Velzen-Blad H, van Moorsel CH, Grutters JC, Biesma DH. Systemic cytokine response in patients with community-acquired pneumonia. Eur Respir J. 2011 Jun;37(6):1431-8. doi: 10.1183/09031936.00074410. Epub 2010 Sep 30.

  PMID: 20884746 BACKGROUND

• Meijvis SC, Hardeman H, Remmelts HH, Heijligenberg R, Rijkers GT, van Velzen-Blad H, Voorn GP, van de Garde EM, Endeman H, Grutters JC, Bos WJ, Biesma DH. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.

  PMID: 21636122 BACKGROUND

• Restrepo MI, Faverio P, Anzueto A. Long-term prognosis in community-acquired pneumonia. Curr Opin Infect Dis. 2013 Apr;26(2):151-8. doi: 10.1097/QCO.0b013e32835ebc6d.

  PMID: 23426328 BACKGROUND

• Paris K, Sorensen RU. Assessment and clinical interpretation of polysaccharide antibody responses. Ann Allergy Asthma Immunol. 2007 Nov;99(5):462-4. doi: 10.1016/S1081-1206(10)60572-8.

  PMID: 18051217 BACKGROUND

• Wagenvoort GHJ, Vlaminckx BJM, van Kessel DA, Geever RCL, de Jong BAW, Grutters JC, Bos WJW, Meek B, Rijkers GT. Pneumococcal conjugate vaccination response in patients after community-acquired pneumonia, differences in patients with S. pneumoniae versus other pathogens. Vaccine. 2017 Sep 5;35(37):4886-4895. doi: 10.1016/j.vaccine.2017.07.088. Epub 2017 Aug 9.

  PMID: 28802755 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ger T Rijkers, Prof

  St. Antonius Hospital

  STUDY DIRECTOR

• Gertjan H Wagenvoort, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Bart JM Vlaminckx, Phd

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 16, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

NL (1)