The vaccine administered in this study is used to prevent meningococcal disease caused by the bacteria Neisseria meningitidis group A,C,W,Y (Nimenrix) and Herpes Zoster disease caused by the Varicella zoster virus (Zostavax).
Conditions
Interventions
Trade Name: Nimenrix
Product Name: Nimenrix
Product Code: Nimenrix
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: Zostavax
Product Name: Zostavax
Product Code: Zostav
Sponsors
National Institute for Public Health and the Environment (RIVM)
Eligibility
Sex/Gender
All
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. 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 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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; • Known or suspected coagulation disorder; • Hormone use, such as post-menopausal hormone or contraceptive pills, within the last 3 months; • History of any neurologic disorder, including epilepsy; • Previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling; • 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 • Previous Varicella Zoster episode (VZV study group) • Vaccination with DT, DT-IPV, TdaP or T within the past 10 years (for the MenACWY-TT study group) • Any vaccination within a month before enrollment; • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to determine differences in vaccine response in the pre-elderly age group (50-65 years) to a primary immunization with vaccine antigens to which no or (very) low prevaccination antibody levels and memory cells exist. Moreover, biomarkers that predict the responsiveness of pre-elderly persons will be explored.;Secondary Objective: See E.5.2 Secondary end points;Primary end point(s): 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 . o VZV: memory T cell reponses against VZV;Timepoint(s) of evaluation of this end point: MenACWY-TT study group: T0: first visit (informed consent, pre-vaccinatie bloodsample, vaccination, filling in short health questionnaire) T1: second visit, 7 days after T0 (blood sampling) T2: third visit, 28 days after T0 (blood sampling) T3: fourth visit, 1 yr after T0 (blood sampling, filling in short health questionnaire) Optional: T4+T5 Men: 5 and/or 8 yrs after T0 (blood sampling) VZV studygroup: T0: first visit (informed consent, pre-vaccinatie bloodsample, vaccination, filling in short health questionnaire) T1: second visit, 14 days after T0 (blood sampling) T2: third visit, 28 days after T0 (blood sampling) T3: 1 year after T0 (blood sampling, filling in short health questionnaire) Optional: T4 VZV: 8 years after T0 (blood sampling) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Determine biomarkers associated with the immunesenescence process and correlate these to the vaccine response. oCytokine levels in serum (for instance: IL-6, TNFa, IL-1ß, IL-10, IL-1ra, IL-17 and IFN?) oBiochemical parameters (for instance: DHEAs, CRP, RF, Vitamin D, cortisol) oCMV IgG levels in serum oTotal IgG, IgM, and IgA levels •To determine MenACWY specific IgG, IgM, IgA, IgG-subclasses and avidity in serum; •To determine Meningococcal specific B cell responses •To determine Tetanus specific B and T cell responses •To determine VZV specific IgG responses in serum •To determine general health status of the participant using a short questionnaire • Explorative: determine additional interesting biomarkers omiRNA omRNA AID •Explorative: Phenotyping of the total B and T cell subsets using PBMCs and counting of different lymphocyte subsets •Explorative: Varicella Zoster specific B cell responses;Timepoint(s) of evaluation of this end point: MenACWY-TT study group: T0: first visit (informed consent, pre-vaccinatie bloodsample, vaccination, filling in short health questionnaire) T1: second visit, 7 days after T0 (blood sampling) T2: third visit, 28 days after T0 (blood sampling) T3: fourth visit, 1 yr after T0 (blood sampling, filling in short health questionnaire) Optional: T4+T5 Men: 5 and/or 8 yrs after T0 (blood sampling) VZV studygroup: T0: first visit (informed consent, pre-vaccinatie bloodsample, vaccination, filling in short health questionnaire) T1: second visit, 14 days after T0 (blood sampling) T2: third visit, 28 days after T0 (blood sampling) T3: 1 year after T0 (blood sampling, filling in short health questionnaire) Optional: T4 VZV: 8 years after T0 (blood sampling) | — |
Countries
Netherlands
Contacts
Public ContactAnnemarie Buisman
National Institute for Public Health and the Environment (RIVM)
Outcome results
None listed