E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
De vaccinaties toegediend in de studie worden gebruikt om
meningokokkenziekte veroorzaakt door Neisseria meningitidis groep
A,C,W,Y (Nimenrix) en Herpes Zoster veroorzaakt door het herpes zoster
virus (Zostavax) te voorkomen. |
|
E.1.1.1 | Medical condition in easily understood language |
Meningococcal disease
Herpes Zoster |
Meningokokkenziekte
Gordelroos |
|
E.1.1.2 | Therapeutic area | Health Care [N] - Environment and Public Health [N06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Het doel van de studie is om verschillen in vaccinatie reactie aan te
tonen op middelbare leeftijd (50-65 jaar) na een primaire immunisatie
met een vaccin antigeen waartegen geen of (hele) lage pre-vaccinatie
antistofwaarden en geheugencellen aanwezig zijn. Biomarkers die de
vaccinatiereactie voorspellen zullen worden onderzocht. |
|
E.2.2 | Secondary objectives of the trial |
See E.5.2 Secondary end points |
Zie E.5.2 Secondary end points |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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 |
|
E.5.1.1 | 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) |
|
E.5.2 | 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, TNFα, IL-1β, IL-10, IL-1ra,
IL-17 and IFNγ)
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 |
|
E.5.2.1 | 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) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Meningococcal responses will be compared with the JIM (NL44863.100.13) and JIM2 (NL6874.100.19)study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Meningococcal responses will be compared with the JIM (NL44863.100.13) and JIM2 (NL6874.100.19)study |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 9 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |