Vaccination of older persons against Sars-Cov-2 and cellular immunogenicity for long term protection (participating in the Doetinchem Cohort Study)

Vaccination of older persons against Sars-Cov-2 and cellular immunogenicity for long term protection (participating in the Doetinchem Cohort Study) - VOCAAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54152

Enrollment

160

Registered

2021-03-11

Start date

2021-03-26

Completion date

Unknown

Last updated

2026-07-20

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

Conditions

Immuunsysteem corona prevention

Interventions

None listed

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results