The aim of this study is to investigate the immune response to a tetravalent MenACWY-TT vaccine in 10-, 12- and 15-year old children primed with the monovalent MenC-TT conjugate vaccine at a young age and to1. determine whether the MenC-specific…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to demonstrate non-inferiority of SBA levels against
MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent
MenACWY-TT vaccine as compared with the group vaccinated with monovalent
MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.
If non-inferiority is demonstrated, the objective is to compare SBA
levels against MenA, MenW and MenY at 1 year (T2) after vaccination between
the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine.
Secondary outcome
- To compare SBA levels against MenC at 1 month (T1) between the vaccine groups
within the
three age groups.
- To compare SBA levels against MenC of >=8 (persistence of vaccine induced
protective
antibody levels) at 1 month (T1) and 1 year (T2) between the vaccine
groups within the three
age groups.
- To compare serum MenC-PS specific IgG levels at 1 month (T1) and 1 year (T2)
between the
vaccine groups within the three age groups.
- To compare the decay rate of SBA levels and MenC-PS specific IgG levels after
secondary
vaccination (i.e. the difference between T2 and T1) between the
vaccine groups within the
three age groups.
- To compare SBA levels against MenA, MenW and MenY at 1 month (T1) between the
three
age groups within the MenACWY-TT vaccine group.
- To compare SBA levels against MenA, MenW and MenY of >=8 at 1 month (T1) and 1
year
(T2) between the three age groups within the MenACWY-TT vaccine group.
- To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels at 1 month
(T1)
and 1 year (T2) between the three age groups within the MenACWY-TT
vaccine group.
- To compare serum IgG antibody levels against tetanus, the carrier protein for
both vaccines, at
1 month (T1) and 1 year (T2)? between the vaccine groups within the
three age groups.
- To compare serum IgA levels against MenA, MenC, MenW and MenY at 1 month (T1)
and at
1 year (T2) between the vaccine groups within the three age groups.
- To compare MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1
month (T1) and 1 year (T2)? between the vaccine groups within the
three age groups.
- To compare SBA and IgG levels against MenC at 1 month and 1 year between the
MenC-TT
group of the current study and the TIM-study for the the 12- and 15-
year olds, to establish the
effect of the age at priming on antibody responses to a second MenC-TT
vaccination during
adolescence.
Background summary
Neisseria meningitides is a gram-negative diplococcal bacterium that causes
septicemia and meningitis. An increase in the relative proportion and the
absolute numbers of Meningococcen serogroup C (MenC) invasive meningococcal
disease during the 1990s led to the development and routine use of conjugate
vaccines. In 2002 a Meningococcal serogroup C conjugated (MenC-TT) vaccination
was implemented into the Dutch National Immunization Programme (NIP) for all
children aged 14 months.
Meningococcal disease occurs comprehensively world-wide. The different
serogroups are geographically distributed around the world. Nowadays, many
young adults go travelling world-wide. In the Netherlands, some of these young
travelers get already a tetravalent MenACWY-TT vaccine.
The incidence of meningococcen serogroup Y (MenY) appears to increase
throughout countries in Europe, including the Netherlands. In the Netherlands,
MenY accounted for 12% of invasive meningococcal disease cases in 2012, an
increase from 2% in 2006. Therefore, when the incidence of invasive MenY
disease in Europa continues to increase, it can lead to serious public health
problems.
In the past years it has become clear that protection induced by a primary
MenC-TT vaccination appears to be age-dependent. This suggest that without a
second vaccination against meninigococci at an older age, children vaccinated
at 14 months will reach the second period of increased risk for invasive
meningococcal disease withk low serologic markers of protective immunity.
In conclusion, with an increasing incidence of MenY and increasing
number of travellelers among the young population , the use of a tetravalent
MenACWY-TT vaccine may be beneficial for the second vaccination at an older age
in the future. Especially for those vaccinated only once at 14 months of age,
to protect the adolescents and maintain the herds community effect that
persists up until today.
Study objective
The aim of this study is to investigate the immune response to a tetravalent
MenACWY-TT vaccine in 10-, 12- and 15-year old children primed with the
monovalent MenC-TT conjugate vaccine at a young age and to
1. determine whether the MenC-specific antibody response after vaccination with
a tetravalent MenACWY-TT vaccine is not inferior to MenC specific antibody
responses after vaccination with the monovalent MenC-TT conjugate vaccine.
2. determine whether there is an age-dependent difference in the primary
response to MenA, MenW and MenY after vaccination with the tetravalent vaccine,
as was previously found for MenC.
3. determine the appropriate age for a tetravalent MenACWY-TT conjugate
vaccination after priming with MenC-TT at young age.
Study design
Intervention study.
Intervention
Participants will receive the vaccination with either the registered
tetravalent vaccine (Nimenrix; 0,5mL) or the registered monovalent (NeisVac-C*;
0,5 mL) at the first visit. Blood and saliva samples will be drawn prior to the
vaccination (T0), 1 month (T1) and 1 year (T2) after the vaccination.
Study burden and risks
Participants benefit from participating in the study by receiving an additional
MenACWY-TT or MenCC-TT 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. Nimenrix and NeisVac-C*
are registered vaccinations 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 ¤25,- in vouchers.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Participants are 10-, 12, and 15-year old children who have received a primary vaccination with a single dose of MenC-PS conjugated (MenC-TT) vaccine NeisVac-C* either during the mass catch-up campaign in 2002 (group 4 and 5) or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP; group 1,2 and 3).
Furthermore, participants have to fulfil all of the following criteria:
- Provision of written informed consent by both parents and (if child is 12 or 15 years old; see Annex 3) child
- Good general health
- Received all regular vaccines according to Dutch NIP
- Adherent to protocol, and available during the study period.
Exclusion criteria
Any of the following criteria at the start of the study will exclude a volunteering child from participation:
- 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 (immunosuppressive) medical treatment that might interfere the results of the study within the last 3 months (like corticosteroids, 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 MenC-TT 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
- Former received a tetravalent MenACWY vaccine
- Received vaccination in the past month
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 | EUCTR2013-001823-38-NL |
| CCMO | NL44863.100.13 |
| OMON | NL-OMON19891 |