Whooping cough is very contagious. Earlier research shows that family members of a child with whooping cough are often also infected with the pertussis bacterium. However, not everyone who is infected with the bacterium develops symptoms. In this…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to identify differences in immunological
biomarkers at inclusion (T1) between confirmed infection (asymptomatic) and
confirmed pertussis (symptomatic) in cases.
We will measure immunological biomarkers in blood and in mucosal samples of
household contacts at inclusion (T1) as well as changes in immunological
biomarkers from T1 to T2 (=2 months after T1). As the primary objective, we
will investigate differences in PT antibody responses at T1 and T2 between
confirmed pertussis and confirmed infection (asymptomatic) cases (see
highlighted rows in Table .
Primary endpoint. PT-IgG and PT-IgA geometric mean concentrations at T1 and T2
Secondary outcome
The secondary objectives of this study are to compare other immunological
biomarkers measured in blood and mucosal samples at inclusion (T1), as well as
changes in immunological biomarkers between T1, TS and T2 in relation to the
case definitions described above. These include: comparison of mucosal and
serum antibody responses, including functional antibody responses, and T and B
cell responses in confirmed pertussis (symptomatic) and confirmed infection
(asymptomatic) cases.
Secondary endpoints:
1. Serum IgG and IgA GMC titers against other pertussis antigens (including
Prn, FHA and Fim) at T1, T2 and TS
2. Mucosal IgG and IgA GMC titers against pertussis antigens (including PT,
Prn, FHA and Fim) at T1, T2 and TS
3. Frequency of pertussis-antigen specific memory B cells and their ratio*s at
T1 and T2
4. Pertussis antigen-specific T cell responses and their ratio*s at T1 and T2.
5. Pertussis-specific T and B cell responses at TS.
6. Assessment of functional pertussis-specific antibody levels in serum and
mucosal samples at all time points
Background summary
Whooping cough (or pertussis) is a respiratory infection that is often
accompanied by severe cough attacks. Almost all children in the Netherlands are
vaccinated against whooping cough. Whooping cough vaccination prevents serious
disease due to whooping cough but does not always prevent infection. As a
result, whooping cough is still common in the Netherlands. Young children in
particular are at risk of developing whooping cough because they have not yet
been (fully) vaccinated. This can also lead to hospitalization.
Study objective
Whooping cough is very contagious. Earlier research shows that family members
of a child with whooping cough are often also infected with the pertussis
bacterium. However, not everyone who is infected with the bacterium develops
symptoms. In this study we want to study why this is the case. To do this, we
want to investigate immunity against the perussis bacterium in the blood and
nose-throat of family members of a child with whooping cough. With this
knowledge we hope to develop better vaccines to control whooping cough. This
knowledge will also contribute to the further optimization of the National
Immunization Program of RIVM.
Study design
Home visit and measurements:
For this study we will visit the family at home at least twice. The first home
visit will take place as soon as possible. The second home visit takes place 2
months later. If a family member develops pertussis-related symptoms after the
first visit, a third home visit will take place.
The following will take place during the home visit:
* filling in a questionnaire about possible complaints, medical/vaccination
history and medication (± 15 minutes).
* blood collection (venapuncture). A maximum of 4 tubes of blood (40 ml total)
are collected from adults. For children the volume depends on the age:
Age Volume (mL)
0-11 months 4 ml
1-2 yr 6 ml
2-6 yr 7.5 ml
7-10 yr 16 ml
11-15 yr 26 ml
16-19 yr 36 ml
* nasal-throat swabs and nasal fluid will be collected. For family members over
16 years of age we will also gently scrape along the inside of the nose to
collect tissue.
The family will be called every week for 2 months. During this phone call we
will ask questions about whooping cough symptoms of participating family
members. This phone call will take approximately 10 minutes.
(Cough) complaints after the first home visit
It is possible that a participant does not have whooping cough complaints at
the first home visit, but that these develop at a later timepoint. If this is
the case, we ask you to contact us directly by telephone. We will then organise
a home visit to take blood and nose-throat samples. We will then test whether
this person is infected with the whooping cough bacterium. The result of this
will be communicated to this person and to the general practitioner /
specialist.
Study burden and risks
Holding an arm when taking a blood sample may feel uncomfortable and the
puncture of the
needle may be a bit painful and a bruise may occur. In children, an anesthetic
cream will be used so that the puncture will hardly be felt. The collection of
material from the throat/nose can cause sneezing and watery eyes. This is of a
temporary nature and there are no major risks associated with participation.
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Listed location countries
Age
Inclusion criteria
Child < 16 years old with a PCR-proven infection with Bordetella pertussis and
minimal 2 asymptomatic household contacts.
Exclusion criteria
Households:
* With a pregnant contact (>34 weeks of gestation)
* With a contact younger than 6 months old or unvaccinated child.
* With a contact with significant disorders, including immunodeficiency,
cancer, oral steroid therapy or any other medical conditions
* With risk contacts for which antibiotic prophylaxis is recommended for the
whole household.
* In which it is not possible to organize visit T1 within 5 days.
Incapacitated Household contacts will be excluded.
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 | NL65912.091.19 |
| Other | wordt aangevraagd |