PneumoniaPhase 4CAPolistaNCT02141009
Community Acquired Pneumonia: Outcome, Quality of Life and Immune Status
A Phase 4 study testing Prevnar 13 in people with Pneumonia and Streptococcus Pneumoniae, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Streptococcus Pneumoniae, Immune Response
- What is being tested?
- Prevnar 13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Pneumococcal polysaccharide vaccination within 6 months prior to inclusion.
- Clinical pneumonia within 1 month prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
St. Antonius Hospital Nieuwegein
Nieuwegein, Utrecht, 3430 EM
About this study
Official title: Response to Pneumococcal Vaccination in Patients After Community Acquired Pneumonia With Streptococcus Pneumoniae Compared to Pneumonia Patients With Another Pathogen.
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.
Read the detailed description
- Introduction \& rationale Community acquired pneumonia (CAP) is an important health problem with significant morbidity, mortality and cost. It is one of the main causes of disease and death worldwide and causes the most deaths by infection in the United States. Streptococcus pneumoniae is the most commonly identified pathogen in CAP.(1)
- pneumoniae is a gram-positive, alpha haemolytic bacterium that is surrounded by an external polysaccharide capsule. There is a difference in composition of this capsule between the 92 different serotypes of S. pneumoniae. Each serotype differs in virulence and prevalence. The external polysaccharide capsule is the main trigger for the specific antibody response and is the basis for pneumococcal vaccines. As it is impossible to develop a vaccine that protects children, immune compromised adults and older adults to all serotypes, the vaccines are based on the most common and virulent serotypes. Nowadays a 13-valent pneumococcal conjugate vaccine, Prevnar 13 (PCV13), is used widely to vaccinate children. This vaccine contains the seven serotypes present in PCV7 (4, 6B, 9V, 14, 18C, 19F and 23F) plus the emerging serotypes 1, 3, 5, 6A, 7F and 19A.(2) In the Netherlands however the 10-valent pneumococcal conjugate vaccine, Synflorix (PCV10), is still used to vaccinate children in the national infant vaccination.(3) Van Mens et al investigated the contribution of S. pneumoniae in CAP by measuring serologic responses in patients who were hospitalized due to CAP in the Ovidius and Triple P study, two consecutive clinical trials initiated by the St Antonius Hospital Nieuwegein. This analysis showed a much higher proportion of patients with pneumococcal pneumonia than was diagnosed by conventional methods alone (i.e. blood cultures, sputum cultures or urine antigen tests). Interestingly some patients with a culture proven pneumococcal pneumonia did not show a serotype specific antibody response to the infecting serotype.(4) Possibly these 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. Borrow et al vaccinated 107 children with PCV7 after invasive pneumococcal disease (IPD) following a routine infant immunization schedule. Pneumococcal serotype specific antibody measurements were performed and showed failure to respond to the infecting serotype in 8 children, even though these children received 2 or more doses of PCV. Two children failed to respond to a serotype different than the infecting serotype.(5) In this study the humoral and cellular immune response after vaccination with Prevnar 13 will be measured in patients who have had CAP with S. pneumoniae. The patients will be recruited from the Ovidius and Triple-P study, two consecutive clinical trials initiated by the St. Antonius Hospital Nieuwegein.(6,7) Patients who survived pneumococcal pneumonia are considered as a high-risk population for pneumococcal disease in the future.(8) Possibly these patients have less response to pneumococcal vaccination because of an impaired immune response against S. pneumoniae. Special interest goes to vaccination responses in the subgroup of pneumococcal pneumonia patients without a culture matching specific antibody response in order to investigate if this reflects the failure to elicit an immune response during pneumonia found by Van Mens et al.
- Objectives Primary Objective:
- To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia compared to pneumonia patients with another pathogen. Secondary Objective(s):
- To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia who failed to elicit a specific antibody response.
- 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 community acquired pneumococcal pneumonia compared to pneumonia patients with another pathogen.
- To investigate the long-term mortality after community acquired pneumococcal pneumonia.
- Study design The design is a prospective cohort study in which response to pneumococcal vaccination and immune function after CAP with S. pneumoniae will be investigated. Patients who were included in the Ovidius or Triple-P study and diagnosed with pneumococcal pneumonia (with cultures, urine antigen test or serology) will be included. The control group will consist of patients who were included in the Ovidius or Triple-P study and diagnosed with community acquired pneumonia with another pathogen.
- Working plan All patients and controls will receive vaccination with Prevnar 13. During this visit information about the medical history, medication usage and daily status will be obtained. Patients are also asked to fill-in a quality of life questionnaire (RAND-36; section F Questionnaires). Sera will be obtained before vaccination and three - four weeks after vaccination to determine antibody response against different serotypes of S. pneumoniae. The study will end with the last visit of the last patient; the duration of the study will be approximately 2 months (dependent on the moment of inclusion of the patient).
- Conditions
- Pneumonia, Streptococcus Pneumoniae, Immune Response
- Being tested
- Prevnar 13
- Keywords
- Vaccination, prevnar, PCV13
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevnar 13Biological
Also called Prevenar 13, pneumococcal 13-valent conjugate vaccin, PCV13
| Study group | Role | What they receive |
|---|---|---|
| Prevnar 13 | Other | Prevnar 13, 1 administration of 1 single dose (0.5mL) Receives: Biological: Prevnar 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Change in avidity between week 1 and week 3-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gertjan Wagenvoort, St. Antonius Hospital
- Investigators
- Ger T Rijkers, Prof, Study director, St. Antonius HospitalGertjan H Wagenvoort, MD, Principal investigator, St. Antonius HospitalBart JM Vlaminckx, Phd, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141009
- Sponsor's protocol ID
- NL44924.100.13
- Other IDs
- 2013-002166-39
- Acronym
- CAPolista
- Status last verified
- Dec 2014
- First submitted
- 13 May 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
File TM. Community-acquired pneumonia. Lancet. 2003 Dec 13;362(9400):1991-2001. doi: 10.1016/S0140-6736(03)15021-0.
PubMed 14683661Principi 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.
PubMed 22397739van 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.
PubMed 21367978Borrow 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.
PubMed 18779338Endeman 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.
PubMed 20884746Meijvis 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.
PubMed 21636122Restrepo 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.
PubMed 23426328Paris 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.
PubMed 18051217Wagenvoort 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.
PubMed 28802755
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Pneumococcal Vaccination in Patients After Community Acquired Pneumonia With Streptococcus Pneumoniae Compared to Pneumonia Patients With Another Pathogen.
- ClinicalTrials.gov ID
- NCT02141009
- Acronym / sponsor ID
- CAPolista / NL44924.100.13
- Conditions
- Pneumonia, Streptococcus Pneumoniae, Immune Response
- Keywords
- Vaccination, prevnar, PCV13
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Introduction \& rationale Community acquired pneumonia (CAP) is an important health problem with significant morbidity, mortality and cost. It is one of the main causes of disease and death worldwide and causes the most deaths by infection in the United States. Streptococcus pneumoniae is the most commonly identified pathogen in CAP.(1)
- pneumoniae is a gram-positive, alpha haemolytic bacterium that is surrounded by an external polysaccharide capsule. There is a difference in composition of this capsule between the 92 different serotypes of S. pneumoniae. Each serotype differs in virulence and prevalence. The external polysaccharide capsule is the main trigger for the specific antibody response and is the basis for pneumococcal vaccines. As it is impossible to develop a vaccine that protects children, immune compromised adults and older adults to all serotypes, the vaccines are based on the most common and virulent serotypes. Nowadays a 13-valent pneumococcal conjugate vaccine, Prevnar 13 (PCV13), is used widely to vaccinate children. This vaccine contains the seven serotypes present in PCV7 (4, 6B, 9V, 14, 18C, 19F and 23F) plus the emerging serotypes 1, 3, 5, 6A, 7F and 19A.(2) In the Netherlands however the 10-valent pneumococcal conjugate vaccine, Synflorix (PCV10), is still used to vaccinate children in the national infant vaccination.(3) Van Mens et al investigated the contribution of S. pneumoniae in CAP by measuring serologic responses in patients who were hospitalized due to CAP in the Ovidius and Triple P study, two consecutive clinical trials initiated by the St Antonius Hospital Nieuwegein. This analysis showed a much higher proportion of patients with pneumococcal pneumonia than was diagnosed by conventional methods alone (i.e. blood cultures, sputum cultures or urine antigen tests). Interestingly some patients with a culture proven pneumococcal pneumonia did not show a serotype specific antibody response to the infecting serotype.(4) Possibly these 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. Borrow et al vaccinated 107 children with PCV7 after invasive pneumococcal disease (IPD) following a routine infant immunization schedule. Pneumococcal serotype specific antibody measurements were performed and showed failure to respond to the infecting serotype in 8 children, even though these children received 2 or more doses of PCV. Two children failed to respond to a serotype different than the infecting serotype.(5) In this study the humoral and cellular immune response after vaccination with Prevnar 13 will be measured in patients who have had CAP with S. pneumoniae. The patients will be recruited from the Ovidius and Triple-P study, two consecutive clinical trials initiated by the St. Antonius Hospital Nieuwegein.(6,7) Patients who survived pneumococcal pneumonia are considered as a high-risk population for pneumococcal disease in the future.(8) Possibly these patients have less response to pneumococcal vaccination because of an impaired immune response against S. pneumoniae. Special interest goes to vaccination responses in the subgroup of pneumococcal pneumonia patients without a culture matching specific antibody response in order to investigate if this reflects the failure to elicit an immune response during pneumonia found by Van Mens et al.
- Objectives Primary Objective:
- To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia compared to pneumonia patients with another pathogen. Secondary Objective(s):
- To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia who failed to elicit a specific antibody response.
- 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 community acquired pneumococcal pneumonia compared to pneumonia patients with another pathogen.
- To investigate the long-term mortality after community acquired pneumococcal pneumonia.
- Study design The design is a prospective cohort study in which response to pneumococcal vaccination and immune function after CAP with S. pneumoniae will be investigated. Patients who were included in the Ovidius or Triple-P study and diagnosed with pneumococcal pneumonia (with cultures, urine antigen test or serology) will be included. The control group will consist of patients who were included in the Ovidius or Triple-P study and diagnosed with community acquired pneumonia with another pathogen.
- Working plan All patients and controls will receive vaccination with Prevnar 13. During this visit information about the medical history, medication usage and daily status will be obtained. Patients are also asked to fill-in a quality of life questionnaire (RAND-36; section F Questionnaires). Sera will be obtained before vaccination and three - four weeks after vaccination to determine antibody response against different serotypes of S. pneumoniae. The study will end with the last visit of the last patient; the duration of the study will be approximately 2 months (dependent on the moment of inclusion of the patient).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevnar 13 | Other | Biological: Prevnar 13Prevnar 13, 1 administration of 1 single dose (0.5mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevnar 13Also: Prevenar 13, pneumococcal 13-valent conjugate vaccin, PCV13 | Biological | Prevnar 13 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Background: PubMed 14683661File TM. Community-acquired pneumonia. Lancet. 2003 Dec 13;362(9400):1991-2001. doi: 10.1016/S0140-6736(03)15021-0.
- Background: PubMed 22397739Principi 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.
- Background: PubMed 21367978van 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.
- Background: PubMed 18779338Borrow 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.
- Background: PubMed 20884746Endeman 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.
- Background: PubMed 21636122Meijvis 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.
- Background: PubMed 23426328Restrepo 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.
- Background: PubMed 18051217Paris 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.
- Derived from this study: PubMed 28802755Wagenvoort 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ger T Rijkers, Prof study director
St. Antonius Hospital
Gertjan H Wagenvoort, MD principal investigator
St. Antonius Hospital
Bart JM Vlaminckx, Phd principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevnar 13 in people with Pneumonia and Streptococcus Pneumoniae, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141009, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.