The primary objective is to assess quantitative antibody responses and functional T-cell and memory B-cell responses to SARS-CoV-2 vaccines in blood of older individuals 64-90 years of age at 28 days after the second vaccination. These response will…
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Brief title
Condition
- Other condition
- Viral infectious disorders
Synonym
Health condition
Immuunsysteem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are vaccine-specific (Spike-protein-specific) antibody
levels in serum, functional T-cell responses and memory B-cell immunity at a
month following the second SARS-CoV-2 vaccination.
Secondary outcome
The secondary aims are to address the function and longevity of the antibody
responses following vaccination (which includes IgG avidity maturation, Ig
isotype differentiation, local mucosal immunity (IgA and IgG) in nose or saliva
and virus neutralization against prevailing SARS-Cov-2 viruses), and in-depth
cellular (B/T) immunity in the long term. In addition, the possible effects of
a past SARS-Cov-2 infection on vaccine response will be determined by measuring
serum antibodies to SARS-CoV-2 virus core proteins. Vaccine responses will be
related to age and frailty. Altogether, this will provide better insight in the
immune responsiveness and immune protection of older persons and ways to
improve vaccination strategies within this specific age group to protect them
from severe SARS-CoV-2 disease.
Exploratory endpoints: Numbers of immune cells and serological biomarkers as
well as composition of gut microbiome before vaccination will be assessed.
These are potential predictors, alone or in combination with frailty, of
antibody responses to vaccination.
Background summary
Vaccination against SARS-CoV-2 is the most effective way to end the current
pandemic, although systemic immune responses induced by the various vaccines
may vary considerably in amplitude, longevity and quality per person. In
addition, with ageing there is a decline in the functioning of the immune
system, making older people more vulnerable to infections and prone to lower
responses to vaccination. We will assess the induction of immune responses to
vaccination in older men and women of 64-90 years of age. In addition we will
investigate whether age, and frailty or underlying lingering inflammation in
these individuals might underly lower immune responses to the SARS-CoV-2
vaccines.
To study this, we will capitalize on the infrastructure and data provided by
the ongoing longitudinal Doetinchem Cohort Study (DCS) (NL63779.041.17). In
particular, we will build on a sub study done in 2016/2017, named Immune System
and Ageing (ISA), in which a frailty index, an extensive phenotyping of cells
and the concentration of inflammatory markers have been documented per person
in a subcohort of the DCS. Because of the availability of these data the
ISA/DCS subcohort provides a unique opportunity to further study immune
function by assessing SARS-CoV-2 vaccine immunogenicity in older persons.
Study objective
The primary objective is to assess quantitative antibody responses and
functional T-cell and memory B-cell responses to SARS-CoV-2 vaccines in blood
of older individuals 64-90 years of age at 28 days after the second
vaccination. These response will be compared with those in younger age groups
(NL76440.041.21).
Study design
Longitudinal observational study.
Study burden and risks
The burden associated with participation involves collection of blood samples
by both venapunction performed by a research nurse (T2 and T4) and by
fingerpricks (T0, T1 and T3) performed by the participant at home. Mucosal
lining fluid (MLF) will be sampled or saliva will be collected by a research
nurse (T2 and T4). In addition, participants will be asked to fill in a brief
questionnaire at each timepoint. They will also be asked to collect one stool
sample before vaccination, which is optional. In case of a SARS-CoV-2 booster
vaccination, participants will be invited to participate in an extension of the
study consisting of 3 additional venipuncture blood samples, 1 additional
finger prick blood sample, 3 additional nasal mucosal lining fluid samples and
4 additional questionnaires. The potential risks of blood sampling are
considered minimal. The results of the study may contribute to a better control
of SARS-CoV-2 disease in older persons.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
• Having participated the ISA study (part of the Doetinchem Cohort Study).
• Willing to receive the SARS-CoV-2 vaccine.
• Willing to give the Informed Consent.
Exclusion criteria
A potential subject will be excluded from participation in this study when a
person already received the second primary SARS-CoV-2 vaccination more than a
month earlier and has not signed the ICF at T0, T1 or T2.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2021-002363-22 |
| EudraCT | EUCTR2021-002363-22-NL |
| CCMO | NL76719.041.21 |