Assess whether COVID-19 in 73-79 year old male and female persons is related to low antibody responses to PPV23 by measuring IgG, IgM and IgA antibody concentrations to all 23 vaccine pneumococcal polysaccharide serotypes pre- and post- vaccination…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vaccinatie tegen pneumokokken (bacterële infectie), en tegen griep (virale infecties), immuunsysteem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pneumococcal serotype- specific serum IgG antibody concentrations (GMCs)
pre-vaccination and four weeks post PPV23 vaccination measured by bead-based
multiplex immune assay.
Secondary outcome
Influenza vaccine strain-specific serum IgG antibody titers (GMTs) will be
measured pre- vaccination and four weeks post-influenza vaccination by
Hemagglutinin Inhibition (HI) assay
Pneumococcal serotype-specific IgM and IgA antibody titers in serum pre- and
post-vaccination
Health status assessment will be done by questionnaires.
Exploratory:
Cross-reactive antibodies against other previous coronaviruses infections
COVID-19 details, including, onset, symptoms and severity
Background summary
SARS-CoV-2 infections have a profound impact on the immune system, which may
hamper subsequent immune reactions against novel challenges. Currently it is
unknown how the observed SARS-CoV-2 induced immune suppression will affect
responses against primary or secondary infections, but also vaccinations. As
vaccination is the prime prevention measure to protect elderly against other
(respiratory) infections, there is an urgent need to investigate whether
previous SARS-CoV-2 infection influence subsequent vaccination responses. We
hypothesize that previous SARS-CoV-2 infection will lead to lower vaccination
response in older adults.
To study this hypothesis, we will investigate the immune/antibody response to
pneumococcal vaccination in older adults with and without previous proven
SARS-CoV-2 infection. As of autumn 2020 all inhabitants of the Netherlands
73-79 of age will be offered a 23-valent polysaccharide pneumococcal vaccine
(PPV23). We will invite persons with proven SARS-CoV-2 infection and an aged
sex matched control group of individuals to participate in a study where blood
will be collected before and after (pneumococcal) vaccination. In individuals
who receive the influenza virus vaccination at the same time, also the antibody
response against influenza will be measured.
The aim of the study is to identify whether (severe) COVID-19 disease will have
long-lasting effects on subsequent vaccination responses in older adults.
Study objective
Assess whether COVID-19 in 73-79 year old male and female persons is related to
low antibody responses to PPV23 by measuring IgG, IgM and IgA antibody
concentrations to all 23 vaccine pneumococcal polysaccharide serotypes pre- and
post- vaccination. Subsequent analyses will be performed comparing vaccine
responses stratified by age, sex and co-morbidities.
Assess whether COVID-19 in 73-79 years old male and female persons is related
to low antibody responses to Influenza vaccine strains by measuring HI titers
pre and post vaccination by comparing vaccine responses in ex-COVID-19 patients
with age and sex matched controls. Subsequent analyses will be performed
comparing vaccine responses to frailty stratifying by age and sex.
Assess potentially cross-reactive antibodies against other coronaviruses.
Identify parameters of the immune system, specific morbidities and/or other
specific health related parameters that correlate with low vaccine
responsiveness.
Study design
Longitudinal observational study
Study burden and risks
The burden associated with participation involves self collection of blood
samples by finger stick (300 ul per timepoint). In addition, the subject will
be asked to fill in two questionnaires. The potential risks are considered
minimal. The results of the study may contribute to a better control of
respiratory diseases 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
-Born between 1941-1947 (73-79 years of age)
-COVID-19 group: Having had a proven (SARS-CoV-2 PCR test positive) COVID-19
infection at least 1 month before study entry
-Control group: Have not had a positive SARS-CoV-2 PCR test
-Willing to receive the PPV23 vaccine
-Be capacitated
-Have signed Informed Consent
Exclusion criteria
-Having had a previous pneumococcal vaccination (PCV or the 23-valent
pneumococcal polysaccharide vaccine (PPV23)).
Design
Recruitment
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 |
|---|---|
| CCMO | NL75268.041.20 |