How long does B-cell memory persist after a single conjugate MenC vaccination and which cells are involved? How is this related to the age of first vaccination? And how to define correlates of protection for immunity and memory after MenC conjugate…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Characterization of the memory B-cell response after MenC (conjugate)
vaccination, using Luminex bead based array technology, serum bactericidal
antibody assay (SBA), FACS analysis and ELISPOT assay.
Secondary outcome
niet van toepassing
Background summary
Bacterial meningitis is caused by several well-known polysaccharide-coated
pathogens such as Haemophilus influenza type B (Hib) Streptococcus pneumoniae
and Neisseria meningitidis serogroup C (MenC). A single MenC
polysaccharide-protein conjugate vaccination was introduced into the National
Vaccination Program (RVP) at the age of 14 months in 2002. Furthermore in 2002,
in a large national campaign all children and adolescents between the age of 1
and 18 years received one dose of MenC conjugate vaccine.
In the following years it will become clear how effective MenC vaccination is
in the long term. Long term protection is mainly based on memory after
vaccination or natural infection. In the Netherlands MenC memory is induced by
a single vaccination. The cellular and molecular pathways for induction of MenC
memory (or any other protein conjugated polysaccharide for that matter) are not
totally clear.
Study objective
How long does B-cell memory persist after a single conjugate MenC vaccination
and which cells are involved? How is this related to the age of first
vaccination? And how to define correlates of protection for immunity and memory
after MenC conjugate vaccination?
Study design
Pilot in healthy adults. After MenC conjugate vaccination, IgG antibody levels,
kinetics, avidity, bactericidal activity and circulating MenC polysaccharide
specific B-cells will be evaluated.
Intervention
One group receives a primary MenC conjugate vaccination; the other two groups
receive either a conjugate MenC or polysaccharide MenC booster vaccination.
Blood will be drawn before and several time points after vaccination.
Study burden and risks
Study participants will be (re)vaccinated with licensed MenC conjugate or
polysaccharide vaccine and will be asked to donate a blood sample
pre-vaccination and at several pre-set time points after vaccination, a total
of 9 blood samples are drawn, each of 20-30 ml, up to maximal 250 ml divided
over 9 time points in 4 weeks .
Anthonie van Leeuwenhoeklaan 9
3720 BA Bilthoven
Nederland
Anthonie van Leeuwenhoeklaan 9
3720 BA Bilthoven
Nederland
Listed location countries
Age
Inclusion criteria
- Good general health;
- Provision of written informed consent;
- Adherent to protocol, and available during the study period.
Exclusion criteria
- Severe acute (infectious) illness of fever (>38.5°C) within 2 weeks before vaccination;
- Present evidence of serious disease(s) demanding medical treatment that might interfere the results of the study;
- Known or suspected allergy to any of the vaccine components (by medical history);
- Known or suspected immune deficiency;
- History of any neurologic disorder, including epilepsy;
- Previous administration of plasma products (including immunoglobulins) within the last year;
- Pregnancy.
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 |
|---|---|
| EudraCT | EUCTR2006-002358-31-NL |
| CCMO | NL12447.000.06 |