To assess achieved immunity against COVID-19 across the different age groups in The Netherlands by testing a representative part of the Dutch population for the presence of SARS-Cov-2 specific antibodies in serum
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess achieved immunity against COVID-19 over time across the different age
groups in The Netherlands by testing a representative part of the Dutch
population for the presence of SARS-Cov-2 specific antibodies in serum
Secondary outcome
To assess the quantity and quality (i.e. antibody functionality and avidity) of
the antibodies raised against SARS-CoV-2 in a representative part of the Dutch
population, and to identify subgroups (including risk groups) with different
levels of immunity against COVID-19
To assess the development of immunity during and after the first pandemic wave
and the period thereafter
To assess the existence of cross-reactive antibodies against established
coronavirus infections in the past
To asses the antibodies in the mucosal fluid
Background summary
The first person infected with the novel coronavirus, SARS-CoV-2, that
presented with COVID-19 disease, emerged on November 2019 in Wuhan, China.
Since then, the virus has spread worldwide, with new cases emerging every day.
The first COVID-19 case in the Netherlands was confirmed on February 27, 2020.
At this moment, the scope of undetected spread of the virus, the fraction of
immune persons due to recent infection, and the course of further spread within
the Netherlands is largely unknown. Since, the spreads rapidly, laboratory
testing of all suspected cases is not feasible anymore. The sera, collected in
the previous PIENTER 3 study, provides an unique opportunity to function as
baseline for antibody levels against SARS-CoV-2 of the Dutch population prior
to the COVID-19 pandemic. In the present study proposal, PIENTER 3
participants, that had previously indicated that they could be approached for a
follow-up study, will be asked to donate a finger prick blood sample by
self-sampling and fill in a questionnaire at different time points during and
after the coronavirus pandemic in the Netherlands. Additionally, at the start
of the second sampling round, we will invite subjects who are more evenly
spread over the Netherlands. This follow-up sampling will obtain insight in the
obtained humoral immunity against SARS-CoV-2 during this first pandemic wave in
the Netherlands. This is important to monitor the status of the generated
immunity against SARS-CoV-2 as well as to identify possible gaps among
different age groups in The Netherlands, to identify risk groups that are not
immune. Furthermore, data from this study can contribute to the evaluation of
recently implemented intervention measurements by policy makers and to take
decisions for new measurements needed). In addition, it may provide clues how
the pandemic will evolve; can we get the pandemic under control, can we
stabilize it, or can we expect a new pandemic period?
Study objective
To assess achieved immunity against COVID-19 across the different age groups in
The Netherlands by testing a representative part of the Dutch population for
the presence of SARS-Cov-2 specific antibodies in serum
Study design
The present study is an observational, longitudinal prospective study in a
representative part of the Dutch population (age 1-93 years). A total of
approximately 6000 persons will be approached, that previously participated in
the PIENTER 3 study (2016/17) and had indicated that they could be approached
for a follow-up study. Additionally, at the start of the second sampling
moment, we will invite a selection of 27200 persons who are more spread over
the Netherlands and also contain 1-2 years olds. Participants will be asked to
donate a finger prick blood sample by self-sampling and fill in a questionnaire
at different time points during and after the coronavirus pandemic in the
Netherlands. The intention is to collect samples in 8500 participants over a
time period of 18 months, with a maximum of 6 different sampling time points,
guided by the epidemiology of the pandemic (reporting rates). The first
timepoint for sampling will be as soon as possible, thereafter sampling moments
will be chosen based on epidemiological information. The study has been
elongated to a max of 15 round, and extra participants were invited. As of
round 8 a subgroup will collect mucosal fluid.
Study burden and risks
The study is designed to include a representative sample of the Dutch
population aged 1-93 years. The main objective can only be investigated in case
all age groups are invited.
Blood collection by fingerpick is a standard procedure which is generally
accepted. The sensation of a fingerprick can be discomfortable for some
participants. The risk of blood collection is considered minimal. The risk of
mucosal fluid is considered minimal. There are no personal benefits for the
participants of the study. We will inform the participants of their personal
test results (if we find antibodies against SARS-CoV-2 in their blood), however
with the notice that the results cannot tell if they are protected against
SARS-CoV-2, and that we also don't know how long the antibodies will last. By
joining this study the participants contribute to the public health related to
the current coronavirus pandemic.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Subject previously participated in the PIENTER 3 study (2016/17), and had
indicated that they could be approached for a follow-up study, or subjects from
a random age-stratified sample from the Netherlands
Exclusion criteria
not applicable
Design
Recruitment
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 |
|---|---|
| CCMO | NL73474.100.20 |
| Other | NL8473 |