The elucidation of T-cell immune responses as well as IgE and IgG subclass antibody responses in children reporting severe local side effects after the fifth ACV vaccination as a component of the DTP-IPV combination vaccine. These responses will be…
ID
Source
Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
vaccinatie en relatie met overreaktie van het immuunsysteem, atopie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
T cells will be stimulated with the various proteins of B. pertussis and both
after 24 hours and 5 days of culture, cells and supernatants will be
harvested. Memory Th1, Th2, Th17 and Treg cell responses will be measured by
analysing cytokines in the culture supernatants by Luminex bead protein assay.
The plasma samples will be used to measure IgG subclasses, especially IgG4 as
well as IgE antibody responses against the pertussis vaccine components
.
Questionnaires will be used to assess local and systemic adverse events,
together with information on the interval and durations of the symptoms.
Information on the presence of atopic disorders will be collected also
Secondary outcome
Total IgG antibody responses against the DTP-IPV vaccine components: several
proteins of B.pertussis (PT, PRN, FHA, FIM2/3), Diphtheria toxoid and Tetanus
toxoid-specific will be measured in multiplex bead based immunoassays .
Total IgE and antibody titers in all samples will be measured.
HLA types of lymphocytes will be determined by DNA analysis, if parents agreed
to participate on this specific point, to find out whether the incidence of
sever local side-effects is related to specific HLA types of the immune system,
T-cell responses against the other proteins of the DTP-IPV vaccine will be
measured if possible
Background summary
Since the acellular vaccines (ACV) for infants against whooping cough
(pertussis) is introduced in the Netherlands in 2005, qualitative differences
in T-cell immunity to ACV and the whole cell vaccine (WCV) have been described.
Moreover, high T-cell immune responses against pertussis after ACV
vaccinations have been associated with adverse events after vaccination.
Vaccines are first administered at an age when the immune system is not yet
fully developed and the (long term) effects of changes in the vaccination
program are largely unknown. This study aims to investigate whether there is a
direct correlation with T-cell immune responses after the high-dose ACV
vaccinations at infant age and the severe local side effects after the fifth
consecutive ACV preschool booster vaccination at 4 years of age.
Study objective
The elucidation of T-cell immune responses as well as IgE and IgG subclass
antibody responses in children reporting severe local side effects after the
fifth ACV vaccination as a component of the DTP-IPV combination vaccine. These
responses will be compared with those in children without reporting any adverse
reactions or with those children having only mild local reactions after
vaccination. The Th1, Th2, Th17 and regulatory T-cell cytokine repertoires and
IgG subclasses as well as IgE antibody levels against the two most important
components present in the pertussis vaccines will be studied.
Study design
Case control study:
After reporting local side effects due to the boostervacination at 4 years of
age, participants are being asked for blood sampling. One blood sample around
10 days after booster vaccination and questionnaires concerning adverse
events and atopic diseases will be taken.
Study burden and risks
Venapuctures have not been associated with real risks
A. van Leeuwenhoeklaan 9
3721 MA
NL
A. van Leeuwenhoeklaan 9
3721 MA
NL
Listed location countries
Age
Inclusion criteria
Cases:
One group of 4 years old children with a local reaction (swelling and/or redness) of more than 5 cm within 48 hrs after the booster vaccination with (Infanrix-IPV).
Controls:
4 years old children without any local reaction (swelling and/or redness) of less than 1 cm within 48 hrs after the booster vaccination with (Infanrix-IPV). ;Controls:
within 48 hrs after the booster vaccination with ACV (Infanrix-IPV)
Exclusion criteria
•evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids within the last 3 months, that might interfere with the results of the study
•any known primary or secondary immunodeficiency
•vaccination with any other vaccine than those used in the NIP within a month before the blood sampling
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 |
|---|---|
| ISRCTN | ISRCTN65428640 |
| CCMO | NL37373.100.11 |