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Vaccination, Immunity and Aging Research

Vaccine immunogenicity in Dutch frail versus non-frail older individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23996
Enrollment
200
Registered
2020-08-03
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

RIVM
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
• 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

Contacts

Public ContactLinde Woudstra

RIVM

linde.woudstra@rivm.nl0031 030 2744079

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)