The main objective of this study is to determine differences in vaccine responses in the pre-elderly age group (50-65 years of age) to a primary immunization with vaccine antigens to which no or (very) low pre-vaccination antibody levels and memory…
ID
Source
Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
virale infectziekten (niet meer in te vullen boven)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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
Background summary
The world population is ageing. In 2060 about 30% of the population is
predicted to be above 65 years, compared to 17.4% in 2010. Population ageing
has implications for the medical conditions, as with age the vulnerability for
chronic diseases and severe infections increases. Prevention of infectious
diseases by immunization of the elderly population is a prerequisite to
establish healthy ageing.
Due to the demographic changes in the future population, vaccination programmes
need to shift to a life-course scheme. Childhood vaccinations remain extremely
important to induce immunity, but it is also necessary to maintain immunity
afterwards, before reaching old age. Immunization of elderly is challenging,
due to changes in the immune system with age, which cause difficulties to
respond to vaccination (immunesenescence). It is suggested that immunization
against antigens has to be established before the onset of immunesenescence,
most probably in the 5th or 6th decade of life. Using this strategy, the
protection of elderly against infectious diseases might be improved. Biomarkers
that predict low vaccination responses earlier in life might also help to
protect the aged population, since precautions can be taken before the onset of
immunesenescence.
The vaccin against Meningococcal A,C,W and Y will be adminstered to part of the
participants. This vaccin is used, because the immunity in the adults and
elderly population against Meningococcal is very low at this moment.
Differences in response will be measured in this pre-elderly study groep at the
serological and cellular aspects. Moreover, cellular immunity against the
Varicella Zoster vaccin will be studied in a different study group of
pre-elderly persons. Implementation of the Varicella Zoster vaccin into the
Dutch National Program at this moment is toppic of fierce debate, since the
vaccin is not causing optimal protection in elderly persons. The results of
this study will contribute to the knowledge connected to immunsenescence and
possibly help to set up and effective vaccinescheme for the future.
Study objective
The main objective of this study is to determine differences in vaccine
responses in the pre-elderly age group (50-65 years of age) to a primary
immunization with vaccine antigens to which no or (very) low pre-vaccination
antibody levels and memory cells exist. The MenACWY-TT (against Meningococcal
ACWY) and VZV (against Varicella Zoster) vaccines will be used to study these
differences. Moreover, biomarkers that predict the responsiveness of
pre-elderly persons will be explored.
Study design
Longitudinal intervention study, explorative biomarker study
Intervention
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 pre-vaccination and 7 days, 28
days, and 1 year after vaccination. Optional: participants will be asked to
participate in a folllow-up study with blood samples drawn 5 and/or 8 years
after vaccination.
50 (+/- 10) participants receive one vaccin against Varicella Zoster (Zostavax
- Sonifi Pasteur). The vaccination is performed subcutaneously in the upper arm
at the start of the study. Blood samples are drawn pre-vaccination and 14 days,
28 days, and 1 year after vaccination. Optional: participants will be asked to
participate in a follow-up study with a blood sample drawn 8 years after
vaccination.
Study burden and risks
Participants will benefit from participating in this study by receiving an
additional vaccination against Meningococcal A,C, W and Y or Varicella Zoster.
From the public health perspective, participation in this study will contribute
to improvement of the National Vaccination Prgramm, by improving knowledge of
vaccination response at pre-elderly age. Vaccination and venapunctures are
unpleasant at the moment of injection, however, they are low risk invasive
procedures. Nimenrix and Zostavax are registered vaccines in the Netherlands.
Adverse reactions to the vaccines may occur but they are expected to be mainly
local and transient. Severe allergic reactions to one of the vaccine components
are unlikely to occur. As a compensation for the vaccination and the
venapunctures, all participants will receive a total of ¤25,- in vouchers. If
participants are participating in the follow-up study, they will receive a
voucher of ¤15 for every extra timepoint.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3720BA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3720BA
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000967-42-NL |
| Other | NL4518 |
| CCMO | NL48510.100.14 |
| OMON | NL-OMON25211 |