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

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2006-002358-31-NL
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-17
• Study Completion: 2007-12-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Any of the following criteria will exclude a volunteer from participation, at the start of the study:
- 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 6 months;
- Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: How long does B-cell memory persist after a single conjugate MenC vaccination in adults and which cells are involved?;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?;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.