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Vaststellen van ziekteverwekkers van griepachtige verschijnselen en karakteriseren van de afweerrespons bij ouderen in Nederland


- candidate number19551
- NTR NumberNTR4818
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2014
- Secondary IDsNL49128 IIV-277
- Public TitleVaststellen van ziekteverwekkers van griepachtige verschijnselen en karakteriseren van de afweerrespons bij ouderen in Nederland
- Scientific TitleIdentification of potential pathogens responsible for influenza-like illness in elderly in The Netherlands. Evaluation of humoral and cellular immunity against identified microorganisms
- ACRONYMGRIEP-3
- hypothesisThe general public is questioning the effectiveness of seasonal influenza vaccination in elderly as a result of the general impression that all influenza-like illness (ILI) is caused by an influenza virus infection. However, several pathogens, both viral and bacterial, can cause ILI. A better understanding of the percentage of ILI caused by an influenza virus infection and the contribution of other respiratory viruses or involvement of bacteria will allow a better appreciation of seasonal influenza vaccines. The immune response against identied pathogens will be further characterized.
- Healt Condition(s) or Problem(s) studiedInfectious diseases, Influenza, Older adults, Viral, Bacterial
- Inclusion criteria1. 60 years of age and older;
2. Willing to present when influenza-like-illness (ILI) symptoms occur;
3. Signed Informed Consent.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2014
- planned closingdate30-jun-2015
- Target number of participants4000
- InterventionsN/A
- Primary outcomePrimary: to determine the percentage of ILI attributable to influenza virus in elderly individuals > 60 years of age
- Secondary outcomeSecondary: to determine the relative contribution of influenza viral subtypes
Secondary: to determine humoral and cellular immune responses to influenza virus
Secondary: to identify which microorganisms (viral and bacterial) present in nasopharynx and oropharynx of elderly suffering from ILI are potential other causes for ILI
Secondary: to determine humoral and cellular immune responses towards the potential pathogens identified in PCR/culture data
Secondary: to gain insight in the influence of viral presence on co-colonization of well-known respiratory bacteria like S. pneumoniae, H. influenzae, M. catarrhalis, S. aureus in elderly by comparing colonization during ILI, after recovery and without having had ILI (baseline)
Secondary: to compare the presence of S. pneumoniae in nasopharyngeal swab with saliva
Exploratory: to evaluate whether differences can be found in incidence of influenza virus infection between subjects who have, and those who have not, received the seasonal influenza vaccine in the year of study
Exploratory: to compare the incidences of the detected pathogens with other available age group cohorts or with other cohorts of the same age group, such as the previous GRIEP-1/-2 study
Exploratory: to evaluate the immune responses to different herpesviruses in the context of a possible role in immunosenescence
Exploratory: to analyze the intestinal microbiome in context of influenza vaccination response and identified microorganisms
Exploratory: to evaluate whether there is a difference in the general physical and mental health condition as assessed by SF-36 questionnaire and vaccine acceptance between the subjects that report with ILI and the whole study population
- TimepointsTimepoint 1: Within 72 hours after onset of fever and at least 1 other ILI symptom;
Timepoint 2: 2-3 weeks after timepoint 1;
Timepoint 3: 7-9 weeks after timepoint 1;
Extra timepoint 1: Any timepoint in subjects who do not (yet) have ILI symptoms during the influenza season and a repeat timepoint 2-3 weeks after extra timepoint 1.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.A.J. Boxtel, van
- CONTACT for SCIENTIFIC QUERIESPhD J. Beek, van
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports (VWS)
- Publications
- Brief summaryThe public is questioning the effectiveness of seasonal influenza vaccination in elderly as a result of the general impression that all influenza-like illness (ILI) is caused by an influenza virus infection. However, several pathogens, both viral and bacterial, can cause ILI. A better understanding of the percentage of ILI caused by an influenza virus infection and the contribution of other respiratory viruses or involvement of bacteria will allow a better appreciation of seasonal influenza vaccines. In addition, information will be collected on the humoral and cellular immune responses induced by the different viruses, bacteria and influenza vaccination, the severity of respiratory symptoms during ILI, respiratory symptoms in the absence of ILI, the acceptance of influenza vaccination and the influence of the intestinal microbiome on the immune responses after infection or vaccination. Elderly either community-dwelling or living in nursing homes will be included.
- Main changes (audit trail)
- RECORD30-sep-2014 - 27-okt-2014


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