Strengthening memory immunity in the aged population by vaccinating pre-elderly

Conditions: vaccin, pre-elderly, immunesenescence, ageing, biomarkers

Registration Number: NL-OMON25211

Lead Sponsor: RIVM, UMCG

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

Good general health;

-50-65 years of age;

Exclusion Criteria

-Antibiotic use or fever (>38 ᵒC) within 14 days of enrollment;

-Present evidence of serious disease(s) demanding immunosuppressive medical
treatment, like corticosteroids, that might interfere with the results of the study within
the last 3 months;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine differences in vaccine response in the pre-elderly age group (50-65) to the<br>MenACWY-TT and VZV vaccine. Primary parameters to determine these differences<br>will be:<br /> <br>-MenACWY-TT: Meningococcal specific serum bactericidal antibody (SBA) levels pre-vaccination (T0) and 7 days (T1), 28 days (T2), and 1 year (T3) post-vaccination.<br /> <br>-VZV: memory T cell responses against VZV pre-vaccination (T0) and 14 days<br>(T1), 28 days (T2), and 1 years (T3) post-vaccination.

Secondary Outcome Measures

Name	Time	Method
-Determine biomarkers associated with the immunesenescence process and correlate<br>these to the vaccine response.<br /> <br>-To determine Meningococcal specific IgG, IgM, IgA, IgG-subclasses and avidity;<br /> <br>-To determine VZV specific IgG responses in serum<br /> <br>-To determine general health status of the participant using a short questionnaire<br /> <br>-Explorative: To determine Meningococcal specific B cell responses<br /> <br>-Explorative: To determine Tetanus specific B and T cell responses<br>