The assessment of the duration of the cellular immunity to Bordetella pertussis after an extra ACV booster and the relationship between the memory B- cells and antibody responses. The methods used in the study are:B- and T- cell memory responses and…
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Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
immunologie na vaccinatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be pertussis specific memory B- and T- cell
responses as well as antibody levels and affinity against the various proteins
of pertussis and the other components of the DTPacv-IPV-Hib vaccin.
Secondary outcome
If there are enough lymphocytes, the immune response (memory B- and T-cells and
antibody responses) to other vaccine preventable diseases, like measles, mumps,
diphtheria, tetanus and polio will also be measured.
Background summary
Since the incidence of whooping cough (pertussis) is increasing in the
Netherlands, the effect of vaccination against Bordetella pertussis needs to be
addressed.
Because of the increasing incidence of whooping cough at the age of 4, an
acellular booster vaccination (ACV) at 4 years of age is introduced in the
Netherlands in 2001. However, nowadays the peak incidence of whooping cough in
children has shifted to 8-9 years old children. In addition, we also see a rise
in notifications in adolescents and adults. Therefore, in some countries, e.g.
Germany and France, an extra acellular booster vaccination has been given to
the 9-14 years old children. Also in Belgium they will introduce an extra
booster vaccination in 14-16 years old children. Because of the shift in the
prevalence peak, the effect of the booster vaccination on the long term
immunity against Bordetella pertussis needs to be addressed in this specific
age group.
This study aims to investigate the longitudinal kinetics of the effect of the
ACV booster vaccination on the memory B- and T- cell immunity in children who
are primary vaccinated with whole cell vaccine (WCV) and boostered with ACV.
Furthermore, the relationship between the cellular immunity and the antibody
responses after ACV booster will be addressed in order to gain insight if
further booster vaccinations are required.
Study objective
The assessment of the duration of the cellular immunity to Bordetella pertussis
after an extra ACV booster and the relationship between the memory B- cells and
antibody responses.
The methods used in the study are:
B- and T- cell memory responses and antibody levels against the various
components present in the acellular pertussis vaccine.
Study design
Intervention study: An extra ACV booster vaccination will be given to children
of 8-9 years old. One pre-vaccination blood sample will be taken and three
post-vaccination blood samples will be taken at 28 days, 1 year and 5.5-6 years
in which the frequency of memory B- cells will be assessed. In a control group
children who have received the regular DTP vaccination without the extra
pertussis vaccination will be recruited and one blood sample will be taken 1
year after the regular DTP vaccination.
A control group for the fourth bloodsamples (5.5-6 years post vaccination)
comprises participants of an other RIVM study. This study investigates the
appropriate age for a second Meningococcal serogroup C vaccination (TIM-studie;
NL 35207.100.11). Blood samples will be collected for the TIM-study in children
15 years of age. No extra blood sample is required for the control group 5.5-6
years post ACV vaccination.
Questionnaires including questions concerning clinical manifestations of
whooping cough will also be completed.
Intervention
The combination vaccine DTPacv-IPV (Boostrix polioTM) produced by GSK
containing a 3 component ACV (Pertussis toxin (Ptx), filamentous hemagglutinin
(FHA) and pertactin (Prn), tetanustoxoid, difterietoxoid and inactivated polio
virus, will be given 8-9 years old children who received the DTPwcv-IPV-(Hib)
at 2,3,4 and 11 months old and DTP + a three component ACV (Monovalent ACV by
GlaxoSmithKline (GSK)) as a booster vaccination at 4 years old. The extra
pertussis vaccination is combined with the DT-IPV and MMR vaccination which
they receive in the regular immunization program. One pre- and three
post-vaccination (28 days, 1 year and 5.5-6 year) blood samples will be taken.
In the control group one blood sample will be taken 1 year after the regular
DTP vaccination.
A control group for the fourth bloodsamples (5.5-6 years post vaccination)
comprises participants of an other RIVM study. This study investigates the
appropriate age for a second Meningococcal serogroup C vaccination (TIM-studie;
NL 35207.100.11). Blood samples will be collected for the TIM-study in children
15 years of age. No extra blood sample is required for the control group 5.5-6
years post ACV vaccination.
Study burden and risks
Memory B- and T- cell immunity and the relationship between memory B- cells and
antibody responses after a booster with an acellular pertussis vaccine will be
addressed. This requires a blood sample of 15 ml per child pre- and
post-vaccination (total of three blood samples). A volume of 15 ml is needed to
be able to do all the memory B- cell tests against the five most important
proteins of Bordetella pertussis. With less material, B- cell responses against
just one or two proteins of pertussis will be measured. A questionnaire will be
used to relate immune functions to clinical manifestations of whooping cough.
We expect 5% of all parents to consent in participation based on our
experiences with a previous study. The total number needed will be 70 children.
There will be no risk for the participants. In the controlgroup 20 children
will participate.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3720 BA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3720 BA
NL
Listed location countries
Age
Inclusion criteria
A population of healthy, Dutch 8-9 years old children who received four vaccinations at 2,3,4 and 11 months with DTPwcv-IPV-(Hib) and a booster vaccination at 4 years old with a three component ACV will be recruited.
Exclusion criteria
Any of the following criteria will exclude a volunteer from participation, at start of the study:
• Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids that might interfere with the results of the study within 3 months.
• Any known primary or secondary immunodeficiency.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-002378-37-NL |
| CCMO | NL23149.000.08 |