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ID
Source
Brief title
Health condition
not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assess the relation of frailty in 73-79 years old male and female persons with antibody responses to both vaccine pneumococcal polysaccharide serotypes and the Influenza virus vaccine strains by measuring HI titers pre and 4-6 weeks post vaccination.
Secondary outcome
• Determine the persistence of antibody responses to PPV23 related to frailty in older persons till 2 years post vaccination.
• Assess baseline numbers of immune cell subsets as well as the inflammatory status at baseline and integration of these data for their association with frailty and vaccine
• Assessment of inter-individual differences in biological ageing of the immune system with specific frailty characteristics or morbidities that are related to low vaccine responses. subgroups of individuals more at risk for lower vaccine responsiveness can be identified.
• Monitoring possible inference of infection with COVID-19 on vaccine responsiveness by measuring virus-specific serum IgG antibodies to COVID-19
Background summary
With ageing there is a decline in the functioning of the immune system, making older people more vulnerable for infections and resulting in a smaller boost of the immune system in response to vaccination. Since there is great heterogeneity in the rate at which immune function declines, it is important to identify elderly at risk for low vaccination responses and thus at higher risk for infection. We hypothesize that frailty in older individuals might underly low responses to the 23-valent polysaccharide pneumococcal vaccination (PPV23) that will be implemented in the National immunization program in autumn this year for elderly 73-79 years of age.
To study this hypothesis, we will capitalize on the infrastructure and data provided by the ongoing longitudinal Doetinchem Cohort Study (DCS) (NL63779.041.17), which includes available frailty data of all participants, to assess the immune response to PPV23 and the yearly Influenza vaccine in relation to frailty. In the DCS, persons originally 20-59 years of age at study start, have been followed for over 30 years (N>3700). Various frailty parameters have been assessed in these participants. Based on these, a frailty score (index) has been determined by using the most recent information on 36 frailty-related “health deficits”, i.e. specific (co)morbidities, tests of physical (dys)functioning and cognition . Because of these data the DCS provides a unique opportunity to get insight into factors contributing to vaccine immunogenicity in older persons. Recent data from a sub-cohort of the DCS aged 60-80 years revealed that lingering inflammation is associated with frailty. Therefore frailty may be linked to reduced immune function and vaccination responses.
Study objective
We hypothesize that frailty in older individuals might underly low responses to the 23-valent polysaccharide pneumococcal vaccination (PPV23) that will be implemented in the National immunization program in autumn this year for elderly 73-79 years of age.
Study design
Visit T0 (-4 till 0 week pre vaccination); Visit T1 (4-6 weeks post vaccination); Visit T2 (10-11 months post vaccination); Visit T3 (22-24 months post vaccination)
Intervention
venapunction
Inclusion criteria
• Participant in round 6 of the Doetinchem Cohort study and born between 1941-1947
• Willing to receive the PPV23 vaccine in 2020
• Have signed Informed Consent.
Exclusion criteria
• Having had a previous pneumococcal vaccination
• Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine.
• Receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) daily corticosteroids (locally applied including inhaled steroids are acceptable) within 2 weeks of study entry.
• Repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the last month.
• Receipt of a recent organ- or bone marrow transplant during the last 5 years .
• Have an anatomical or functional asplenia.
• Receipt of blood products or immunoglobulin, within one month of the study entry.
• Known or suspected coagulation disorder that in the opinion of the investigator would contraindicate against receiving an intramuscular injection or undergo frequent blood sampling.
• Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV).
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8812 |
| Other | METC Utrecht : METC 20-510 |