Characterization of T cell responses in young children after influenza infection
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Height of the cellular immune response after stimulation of the white blood
cells with influenza virus in vitro. The response will be characterized based
on; influenza-specific cytokine induction, number of influenza-specific T
cells, T cell activation and functional status.
Secondary outcome
Humoral immune response
Background summary
Morbidity and mortality caused by influenza infection is higher in young
children compared to adults. This may be due to induction of an inadequate
immune response in young children. In the USA it is advised to vaccinate
children in the age of 6 months to 59 months. The efficacy of vaccines is
determined by serological assays like the hemagglutination inhibition assay
(HAI). However, the current vaccines are not 100% protective in young children.
Therefore, better insight in the mechanisms of the immune system (cellular
immunity) is required to develop improved vaccines against influenza in this
group.
Study objective
Characterization of T cell responses in young children after influenza
infection
Study design
During the influenza season of 2007/2008, 2008/2009 and 2009/2010 children
infected with influenza will be recruited via hospitalisation. At entry of the
hospital, a serum sample (1 ml) will only be taken in combination with a
regular venapunction for diagnostic purposes. 4-6 weeks after hospitalisation,
a second blood draw will take place for isolation PBMC and serum. 5 ml blood
will be drawn from children 0-4 years and 10 ml blood from children 5-9 years
old.
Control populations will consist of children and adults, recruited before onset
of the 2009/2010 influenza season. Procedure of recruitment and blood sampling
in the control group of children will be similar as described for the children
infected with influenza. Adults will be recruited via RIVM/NVI and blood will
be drawn (15 ml) for isolation of PBMC and serum.
Blood will be prepared on day of blood draw. The isolated PBMC will be tested
directly in in vitro experiments to determine T cell responses. Serum of both
time points will be tested in HI assay.
Study burden and risks
Potential minor bruise, limited pain with blood sampling. Participation to this
study likely enables future development of improved vaccines in children.
Postbus 85090
3508 AB Utrecht
Nederland
Postbus 85090
3508 AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Index population: children hospitalized at Wilhelmina Children*s Hospital, Spaarneziekenhuis, St. Antonius Ziekenhuis, and Diakonessenhuis with influenza infection.
Control Group: children hospitalized at Wilhelmina Children*s Hospital without influenza infection.
Adults: adults employed at RIVM/NVI without influenza infection.
Exclusion criteria
Index population: prematurity (gestational age < 37 weeks), chronic lung disease, severe congenital diseases, known immunological dysfunction, current infectious disease other than influenza, hematologic disorder, usage of anticoagulants, influenza vaccination;Control group: prematurity (gestational age < 37 weeks), chronic lung disease, severe congenital diseases, known immunological dysfunction, current infectious disease, hematologic disorder, usage of anticoagulants, influenza vaccination;Adults: known immunological dysfunction, current infectious disease, hematologic disorder, usage of anticoagulants, influenza vaccination
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18924.041.07 |