Specific B-cell Memory After a Single Dose or Booster MenC Conjugate Vaccination: a Pilot Study in Adults

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: NeisVac‐C Pharmaceutical Form: Trade Name: Meningovax A+C Pharmaceutical Form: CONDITION: Bacterial meningitis is caused by several pathogens such as Hib, Streptococcus pneumoniae and MenC. A MenC conjugate vaccination was introduced into the National Vaccination Program at the age of 14 months in 2002. In the following years it will become clear how effective MenC vaccination is in the long term. Long term protection is based on memory after vaccination or natural infection. In the Netherlands MenC memory is induced by a single vaccination. PRIMARY OUTCOME: Main Objective: How long does B‐cell memory persist after a single conjugate MenC vaccination in adults and which cells are involved? Primary end point(s): 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 Objective: 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? INCLUSION CRITERIA: Participants have to fulfil all of the following criteria, and will be screened for these after signing the informed consent: ‐ Good general health; ‐ Provision of written informed consent; ‐ Adherent to protocol, and available during the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 7bef3f52f206f9e54c6e9a4badcee1cd8a150f3f
First added on: Aug 21, 2024