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

Phase 4

Completed

• Conditions: bacterial meningitis; spotted fever; 10004018

• Registration Number: NL-OMON30102
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Good general health;
- Provision of written informed consent;
- Adherent to protocol, and available during the study period.

Exclusion Criteria

- 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 year;
- Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Characterization of the memory B-cell response after MenC (conjugate)<br /><br>vaccination, using Luminex bead based array technology, serum bactericidal<br /><br>antibody assay (SBA), FACS analysis and ELISPOT assay.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>niet van toepassing</p><br>