I. Evaluation of the nature and maintenance of specific cellular immune mechanisms after infection with Bordetella pertussis in different age groups, to identify critical parameters for pertussis re-emergenceII. To relate individual patient*s…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main immunological study parameters: trends per age group or time interval
after infection in: i) frequencies, functionality and (fine)specificity of
pertussis-reactive T cells; ii) titers and functionality of pertussis specific
antibody titers; and iii) frequencies, functionality and specificity of
pertussis-reactive memory B cells and plasma cells
Secondary outcome
Secundary microbiological study parameters:
strain variation of patients* pertussis isolates in relation to global trends
and in relation to patients* immune responses.
(per age group): estimation of pertussis incidence and underreporting in the
general population, especially the elderly (by comparing the frequency of cases
in source populations with national notification data); strain prevalence
Background summary
Bordetella pertussis, the causative agent of whooping cough, has remained
endemic despite intensive vaccination. The clinical course of pertussis
infection varies widely, from most typical and severe with complications, often
in unprotected infants, to mild or asymptomatic in older age groups. In 13-20%
of adults with prolonged cough, pertussis is the cause. Waning immunity on the
one hand, and strain adaptation and changing transmission patterns on the other
hand, have been proposed to underlie insufficient protection and the current
re-emergence of the disease. Since serum antibody titers alone do not fully
correlate with protection, and Bordetella pertussis evades humoral effector
mechanisms, cell mediated immune mechanisms involving specific T and B
lymphocyte populations play a role as well. Waning pertussis immunity
postulates that in previously immune (exposed) individuals these correlates of
protection dysfunction or disappear with time. How this translates into
magnitude, function and fine-specificity of lymphocytes has not been studied.
In this study we want to compare the induction, nature and maintenance of
specific cellular immune mechanisms after pertussis infection in different age
groups, in relation to currently circulating strains. This evaluation is
important to define cellular correlates of protection, needed to develop
improved pertussis vaccines and vaccination schedules
Study objective
I. Evaluation of the nature and maintenance of specific cellular immune
mechanisms after infection with Bordetella pertussis in different age groups,
to identify critical parameters for pertussis re-emergence
II. To relate individual patient*s specific cellular immune parameters to
genetic characteristics of the patient*s isolate (if available), such as
lineage and strain adaptation.
Study design
The study is an observational study in three parts:
I. prospective, with venous blood sample and a questionnaire
II. prospective, with venous blood sample, a questionnaire and a nasopharyngeal
and mouth swab.
III. retrospective, with venous blood sample and a questionnaire
Study burden and risks
Burden is minimal, the study consists only of one venous blood sample and for
participants in part II also a nasopharyngeal and mouth swab
Postbus 1
3720 BA Bilthoven
NL
Postbus 1
3720 BA Bilthoven
NL
Listed location countries
Age
Inclusion criteria
I: Patients being within a 4 weeks period after a laboratory-confirmed diagnosis of pertussis
II: Household contact of I
III: Subjects being recovered or recovering from a laboratory-confirmed pertussis infection which was diagnosed > 4 weeks earlier
Exclusion criteria
A: Immunosuppressive medical treatment, like cytostatics and prednisolons that might interfere with the results of the study, within the previous 3 months.
B: Any known primary or secondary immunodeficiency
C: Bleeding disorder
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 | NL16334.040.07 |