|- candidate number||3871|
|- NTR Number||NTR1419|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-aug-2008|
|- Secondary IDs||LTR138 Laboratory for Vaccine Preventable Diseases (LTR)|
|- Public Title||Specific B-cell Memory After a Single Dose or Booster MenC Conjugate Vaccination: a Pilot Study in Adults|
|- Scientific Title||Specific B-cell Memory After a Single Dose or Booster MenC Conjugate Vaccination: a Pilot Study in Adults|
|- ACRONYM||B-cell Memory After MenC Vaccination|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Infectious diseases, MenC polysaccharide-protein conjugate vaccination, Memory B cells, Meningitis|
|- Inclusion criteria||1. Good general health; |
2. Provision of written informed consent;
3. Adherent to protocol, and available during the study period
|- Exclusion criteria||1. Severe acute (infectious) illness of fever (>38.5°C) within 2 weeks before vaccination;|
2. Present evidence of serious disease(s) demanding medical treatment that might interfere the results of the study;
3. Known or suspected allergy to any of the vaccine components (by medical history);
4. Known or suspected immune deficiency;
5. History of any neurologic disorder, including epilepsy;
6. Previous administration of plasma products (including immunoglobulins) within the last 6 months;
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-mei-2007|
|- planned closingdate||1-dec-2008|
|- Target number of participants||21|
|- Interventions||- One group receives a primary MenC conjugate vaccination (Neisvac-C). |
- The other two groups receive either a conjugate MenC (Neisvac-C) or polysaccharide MenC booster vaccination (Meningovax A+C).
Blood will be drawn before and several time points after vaccination.
|- Primary outcome||- How long does B-cell memory persist after a single conjugate MenC vaccination in adults and which cells are involved?|
|- Secondary outcome||- How long do serum SBA titers persist in time after a single vaccination with the conjugate MenC vaccine?|
- Despite decline of antibody concentrations in the years after vaccination, do memory B-cells persist?
- Antibody kinetics, it is important to follow the rise of antibody titers after vaccination:
o How long will it take before serum IgG antibodies are detectable and/or rise after primary- or booster vaccination?
o What is the avidity of serum IgG antibodies compared to the primary and booster vaccination?
- In what time period after primary vaccination with MenC are memory B-cells formed and how rapidly do memory B-cells expand after booster vaccination?
- Are there differences (antibody titer levels, IgG subclass distribution and serum antibody avidity) in booster responses between a booster vaccination using the conjugate MenC vaccine or plain serogroup C capsular polysaccharide .
|- Timepoints||Study Calendar: |
Day 0: Pre-vaccination blood sample (20-30ml)
Day 0: Vaccination with MenC conjugate vaccine or Men(A)C polysaccharide vaccine
Day 1: Blood sampling (20-30ml)
Day 3: Blood sampling (20-30ml)
Day 5: Blood sampling (20-30ml)
Day 7: Blood sampling (20-30ml)
Day 9: Blood sampling (20-30ml)
Day 11: Blood sampling (20-30ml)
Day 14: Blood sampling (20-30ml)
Day 28: Blood sampling (20-30ml)
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||PhD G. Berbers|
|- CONTACT for SCIENTIFIC QUERIES||PhD G. Berbers|
|- Sponsor/Initiator ||National Institute for Public Health and the Environment (RIVM), Laboratory for Vaccine Preventable Diseases (LTR)|
(Source(s) of Monetary or Material Support)
|National Institute of Public Health and Environmental Protection (RIVM), Laboratory for Vaccine Preventable Diseases (LTR)|
|- Brief summary||We will evaluate the kinetics of circulating antibodies, investigating the
presence of MenC specific plasma and memory B lymphocytes and antibody
production after polyclonal stimulation of peripheral blood mononuclear
cells (PBMC) in vitro. Vaccine responses after a single or multiple MenC
vaccinations (booster with MenC conjugate or with polysaccharide vaccine)
will be compared with natural immunity without previous vaccinations. It
will be interesting to investigate if the polysaccharide vaccine is capable
of inducing a booster response. And if so, it will be of interest to
characterize this response and compare it to the booster response induced
by the conjugate vaccine.
|- Main changes (audit trail)|
|- RECORD||25-aug-2008 - 29-sep-2008|