virale infectziekten (niet meer in te vullen boven) Determine differences in vaccine response in the pre-elderly age group (50-65 years of age) to the MenACWY-TT and VZV vaccine.
Conditions
Interventions
200 (+/- 10) participants receive one vaccination againt MenACWY-TT (Nimenrix -
GSK). The vaccination is performed intramuscularly in the upper arm at the
start of the study. Blood samples are drawn
Sponsors
RIVM
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, participants must meet all of the following criteria: * General good health * 50-65 years of age * Provision of written informed consent; * Adherent to protocol and available during the study period.
Exclusion criteria
Exclusion criteria: Any of the following criteria will exclude a participant from this study:, * Antibiotic use 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; * Known or suspected allergy to any of the vaccine components (by medical history); * Occurrence of serious adverse event after other vaccination (by medical history); * Known or suspected immune deficiency; * History of any neurologic disorder, including epilepsy;* Known or suspected coagulation disorder; * Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling; * Hormone use, such as post-menopausal hormone or contraceptive pills, within the last 3 months; * Serious surgery within the last 3 months; * Previous vaccination with the MenC, MenC-TT, or MenACWY-TT vaccine. (for the MenACWY-TT study group ) * Previous meningococcal episode (MenACWY-TT study group) * Previous vaccination with VZV vaccine (for the VZV study group) * Previous Varicella Zoster episode (VZV study group) * Vaccination with DT, DT-IPV, TdaP or T within the past 5 years (for the MenACWY-TT study group) * Any vaccination within a month before enrollment; * Pregnant at the start of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is to determine differences in vaccine response in the pre-elderly age group (50-65) to the MenACWY-TT and VZV vaccine. Primary parameters to determine these differences will be: o MenACWY-TT: Meningococcal specific Serum bactericidal antibody (SBA) levels after vaccination o VZV: memory T cell reponses against VZV after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| * Determine biomarkers associated with the immunesenescence process and correlate these to the vaccine response. o Cytokine levels in serum (for instance: IL-6, TNF*, IL-1*, IL-10, IL-1ra, IL-17 and IFN*) o Biochemical parameters (for instance: DHEAs, CRP, RF, Vitamin D, cortisol) o CMV IgG levels in serum o Total IgG, IgM, and IgA levels * To determine MenACWY specific IgG, IgM, IgA, IgG-subclasses and avidity in serum; * To determine VZV specific IgG responses in serum * To determine general health status of the participant using a short questionnaire * Explorative: To determine Meningococcal specific B cell responses * Explorative: To determine Tetanus specific B and T cell responses * Explorative: determine additional interesting biomarkers o miRNA o mRNA AID * Explorative: Phenotyping of the total immuun cell subsets using PBMCs and counting of different lymphocyte subsets * Explorative: Varicella Zoster specific B cell responses | — |
Countries
Netherlands
Outcome results
None listed