This study has been transitioned to CTIS with ID 2024-513640-29-00 check the CTIS register for the current data. The aim of this study is to investigate the immune response to a primary and a booster immunization with a tetravalent MenACWY-TT…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional antibody levels against MenA, MenC, MenW and MenY are measured using
the serum bactericidal antibody (SBA) assay.
Secondary outcome
* To compare SBA levels of >=8 (persistence of vaccine induced protective
antibody levels) at 1 month and 1 year within the two age groups and 1 month
and 1 year after the booster vaccination in the booster-subcohort
* To determine serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels
at 1 month and 1 year and compare between the two age groups and 1 month and 1
year after the booster vaccination in the booster-subcohort
* To determine serum IgG antibody levels against tetanus, the carrier protein
for both vaccines, at 1 month and 1 year and compare within the two age groups
and 1 month and 1 year after the booster vaccination in the booster-subcohort
* To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1
month and 1 year and compare between the two age groups and 1 month and 1 year
after the booster vaccination in the booster-subcohort
* To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at
1 month and 1 year and compare between the two age groups and 1 month and 1
year after the booster vaccination in the booster-subcohort
* To determine long-term persistence of functional serum antibody (IgG, IgA and
IgM) titers (GMTs)/levels (GMCs) 5 years after primary vaccination
* To determine salivary MenA-PS, MenC-PS, MenW-PS and MenY-PS-specific IgG, IgA
and IgM levels after primary and booster vaccination.
* To compare the serum MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA
and IgM levels and SBA titers from this study to the results found in the
StimulAge study (NL48510.100.14)
* To compare the salivary MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG,
IgA and IgM levels from this study to the results found in the StimulAge study
(NL48510.100.14)
* Explorative: to determine an immune cell profile by phenotyping white blood
cells by using flow cytometry in combination with the determination of a
complete blood count (CBC) pre-vaccination.
* Explorative: to investigate the relation between the baseline immune cell
profile and vaccine outcome.
* Explorative: to investigate the relation between the baseline frailty status
(based on the Tilburg frailty index and the handgrip strength test) and vaccine
outcome.
*Explorative: to investigate the relation between monocyte and lymphocyte
function in a subgroup of male and female participants at baseline and vaccine
outcome.
* Explorative: during the course of the study, it could be possible that
additional (frailty-related) immune parameters, such as serum biomarkers or
immune function/cellular responsiveness, turn out to be of interest. These
parameters will then be measured using the most suitable laboratory tests
available.
Background summary
Neisseria meningitides is a gram-negative diplococcal bacterium and is normally
a commensal bacterium in the nasopharynx. However, it can be a devastating
pathogen when it enters the blood stream causing invasive meningococcal
disease. A substantial proportion of disease burden is in adults and the
elderly show the highest case fatality rate by meningococci. Protecting the
increasing elderly population against infectious diseases is essential to
maintain healthy ageing. Vaccination of the elderly population might be
beneficial for the individual by direct protection and, in addition, prevent
spread of disease, leading to herd immunity. However, due to immunesenescence
and waning efficacy of vaccines in elderly, it is challenging to maintain
immunity after vaccination at a later age. Studies evaluating the efficacy and
long-term persistence of antibodies after a primary immunization with
MenACWY-TT conjugate vaccine in the elderly population are crucial but lacking.
Also, no studies including a booster meningococcal vaccination have been
conducted in this age group.
Study objective
This study has been transitioned to CTIS with ID 2024-513640-29-00 check the CTIS register for the current data.
The aim of this study is to investigate the immune response to a primary and a
booster immunization with a tetravalent MenACWY-TT conjugate vaccine in older
persons aged 65-85 years of age.
Study design
Longitudinal intervention study
Intervention
Participants will receive a registered tetravalent MenACWY-TT conjugate vaccine
(Nimenrix) intramuscularly in the upper arm at the first visit. Blood and
saliva samples will be collected prior to (T0), at 1 month (T1), 1 year (T2), 2
years (T3) and 5 years (T5) after vaccination. Half of the participants (n=140)
will also receive a booster meningococcal vaccination with the tetravalent
MenACWY-TT conjugate vaccine at the 1 year timepoint (T2). Blood and saliva
samples will collected from these participants at 1 month (T3), 1 year (T4) and
5 years (T5) after the booster vaccination. At T4 and T5, samples will also be
collected from the participants who only received a single vaccination. During
the T5 visit, only blood samples are drawn, no saliva samples.
During the first visit (T0), participants are asked to fill in a short
questionnaire and to perform a handgrip strength test to determine the frailty
status of said individual.
Study burden and risks
Participants benefit from participating in the study by receiving one or two
MenACWY-TT vaccinations. From the public health perspective, participation in
this study will contribute to the improvement of the national immunization
program (NIP). Vaccination and venepunctures might be unpleasant. However, they
are low risk invasive procedures. Nimenrix is a registered vaccine. Mild
adverse reactions to one of the vaccine components may occur, but reactions 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 venepunctures, all participants will receive a total of
¤25,- in vouchers.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Participants eligible for this study are Dutch older persons 65-85 years of
age, of moderate to good general health with regard to age, who did not receive
a MenACWY-TT vaccine before.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Antibiotic use within 14 days of enrolment
* Severe acute infectious illness or fever above 38.0 °C within 14 days before
vaccination;
* Present evidence of serious diseases either demanding regular use of oral
immunosuppressive medical treatment, like corticosteroids, that might interfere
with the results of the study within the last 3 months or demanding acute use
of high dose oral immunosuppressive that might interfere with the results of
the study within the last 2 weeks;
* Known or suspected allergy to any of the vaccine components (by medical
history);
* Occurrence of a serious adverse event after other vaccination by medical
history;
* Known or suspected immune deficiency;
* Known or suspected coagulation disorder;
* Oral hormone use, such as postmenopausal hormones, within the last 3 months;
* History of one of the following neurological disorders: multiple sclerosis,
Parkinson*s disease, or epilepsy;
* Previous administration of plasma-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;
* Previous confirmed or suspected meningococcal disease;
* Any vaccination within a month before enrolment.
Presence of in-and exclusion criteria will be checked by interviewing the
participant during the first phone call. In addition, presence of in-and
exclusion criteria will be checked at the first study visit again, prior to
signing the informed consent.
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 |
|---|---|
| EU-CTR | CTIS2024-513640-29-00 |
| EudraCT | EUCTR2019-001301-24-NL |
| CCMO | NL72728.100.20 |
| OMON | NL-OMON20287 |