The main purpose of this study is to determine the appropriate age (10, 12 or 15 years) for a second MenC conjugate (MenCC) vaccine immunization in Dutch children that received a primary MenCC vaccination at a young age. A conclusion will be based…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To assess serum bactericidal antibody assay (SBA) levels at T0 and at 1 month
(T1) and 1 year (T2) and 3 years (T3) after the second MenCC vaccination and
determine whether there is a difference between the different age groups in the
levels and the proportion of participants that have an SBA level of >=8
(persistence of vaccine induced protective antibody levels).
Secondary outcome
- To assess serum MenC-PS specific IgG levels at T0 (prior to vaccination) and
at 1 month (T1) and 1 year (T2) and 3 years (T3) after the second MenCC
vaccination and determine whether there is a difference in IgG levels between
the different age groups (persistence of vaccine induced antibody levels)
- To assess avidity of serum IgG antibodies and determine whether there is a
difference in avidity between the different age groups
- To determine whether there is a difference in antibody subclasses (e.g.
IgG1-4, IgG1/IgG2 ratio) between the different age groups.
- To assess whether there is a difference between the different age groups in
the decay rate of MenC-PS specific antibody levels after secondary vaccination.
- To determine whether there is a difference in avidity of IgG antibodies after
primary versus secondary vaccination.
- To investigate longitudinal kinetics of B- and T- cell memory immune
responses after primary and secondary MenCC vaccination (e.g. presence and
functionality of memory B-cells and T-cells prior to and after the second MenCC
vaccination).
- To measure serum IgG antibody levels against tetanus, the carrier protein for
the MenC polysaccharide in the conjugate vaccine, to investigate the effect of
a second MenCC vaccine on these titers.
- To measure salivary and serum IgA levels at T0, T1, T2 and T3 in order to
investigate their correlation and the (longitudinal) kinetics of local and
systemic IgA production after primary and secondary MenCC vaccination. IgA is
the major antibody at mucosal surfaces and considered to be important in
limiting meningococcal colonisation and preventing early invasion.
Background summary
In 2002 a Meningococcal serogroup C conjugated (MenCC) vaccination was
implemented into the Dutch National Immunization Programme (NIP) for all
children aged 14 months. In addition, a catch-up campaign was conducted between
June and November 2002 during which all children between 1 and 18 years were
invited to receive a single MenCC vaccination. Overall vaccine coverage was 94%
and afterwards MenC disease disappeared in the vaccinated cohorts and even
decreased dramatically in the non-immunized cohorts. It is suggested that the
great success of the MenCC vaccination is primarily based on the catch-up
campaign inducing large scale herd immunity by reducing the nasopharyngeal
carriage of MenC bacteria in the population.
Available data derived from studies in the Netherlands and the UK now
show that it might be necessary to introduce a second MenCC vaccine
immunization in the NIP in order to maintain long-term individual and herd
immunity against MenC. MenC-polysaccharide (MenC-PS) specific antibody levels
decline rapidly after primary vaccination in young children. Protection induced
by a primary MenCC vaccination appears to be age-dependant: cohorts vaccinated
at older ages (up to adolescence/early adult) reveal greater and longer lasting
protection than those routinely vaccinated in infancy. Next to an increased
risk of invasive MenC disease in young children, there is an increased risk of
invasive MenC disease during the teenage years. This suggests that a second
MenCC vaccination may be needed to maintain the successful contribution this
vaccine has made to public (child) health in the Netherlands. Without a second
dose of MenCC vaccine at an older age, children vaccinated at 14 months will
reach the second period of increased risk for invasive MenC disease with low
serologic markers of protective immunity.
Study objective
The main purpose of this study is to determine the appropriate age (10, 12 or
15 years) for a second MenC conjugate (MenCC) vaccine immunization in Dutch
children that received a primary MenCC vaccination at a young age. A conclusion
will be based on the quality and quantity of the MenC-PS specific antibody
response against a second MenCC vaccination at these different ages .
Study design
Intervention study
T0: blood and saliva sampling followed by a one time vaccination with the
registered MenC conjugated vaccin (NeisVac-C*)
T1 (28-42 days after T0): blood and saliva sampling
T2 (1 year after T0): blood and saliva sampling
T3 (3 years after T0): blood and saliva sampling
Intervention
One vaccination with the registered Meningococcal C conjugated vaccine
(NeisVac-C*) at the beginning of the study.
Study burden and risks
Participants benefit from participating in the study by receiving an additional
MenCC vaccination. From the public health perspective, participation in this
study will contribute to the improvement of the National Immunisation Programme
(NIP). Vaccination and venapunctures might be painful and unpleasant. On
request of the participant, Xylocainespray can be used to reduce possible local
pain during the venapunction. NeisVac-C* is a registered vaccine in the
Netherlands. Mild adverse reactions to the vaccine may occur but they are
expected to be mainly local and transient. Severe allergic reactions to one of
the vaccine components are unlikely to occur. As a compensation for the
vaccination and the venapunctures, all participants will receive a total of
¤35,- in vouchers.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Healthy children aged 10, 12 or 15 years
Vaccinated according to the Dutch National Immunization Programme (NIP)
Vaccinated (primed) with Meningococcal C conjugated vaccine one time at a young age
Exclusion criteria
- Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination;
- Antibiotic use within 14 days of enrollment;
- Present evidence of serious disease(s) demanding medical treatment that might interfere the results of the study (chronic infection, bleeding disorder, immune dysfunction, genetic anomaly);
- Known or suspected allergy to any of the vaccine components (by medical history);
- Occurrence of (serious) adverse event after primary MenCC vaccination or other vaccination (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 6 months;
- Pregnancy.
- Previous confirmed or suspected meningococcal disease.
- Former received doses of MenC vaccines in addition to the primary vaccination
- Received vaccination within month prior to start of study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-000375-13-NL |
| CCMO | NL35207.100.11 |
| OMON | NL-OMON26279 |