Monitoring immunogenicity of SARS-Cov-2 vaccination in Dutch middle-aged and older individuals (participating in the Doetinchem Cohort Study)

Monitoring immunogenicity of SARS-Cov-2 vaccination in Dutch middle-aged and older individuals (participating in the Doetinchem Cohort Study) - VIDO

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54058

Enrollment

1700

Registered

2021-02-26

Start date

2021-03-09

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

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Having participated in round 6 of the Doetinchem Cohort study or living in a nursing home • Willing to receive the SARS-CoV-2 vaccine or received the vaccination not longer than 1 month in advance for the DC participants or not longer than 7 months ago for nursing home residents. • Willing to sign the Informed Consent.

Exclusion criteria

Exclusion criteria: * participants living in a nursing home already received both primary SARS-CoV-2 vaccinations more than 7 months before signing ICF. * Incapacitated participants

Design outcomes

Primary

Measure	Time frame
Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month till 12 months following the second SARS-CoV-2 vaccination and post booster vaccinations. Vaccine responses will be related to age, sex, co-morbidities and frailty characteristics.	—

Secondary

Measure	Time frame
Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month after the first SARS-CoV-2 vaccination. In addition, the possible interference of infection with SARS-CoV-2 in vaccine responsiveness will be determined by measuring serum antibodies to SARS-CoV-2 virus core protein N. Exploratory endpoints: Cellular and serological biomarkers before vaccination will be identified and related to antibody responses to vaccination. Potentially, differences between vaccines might be assessed depending on the vaccines to be used in this age group of study participants in Doetinchem. In addition, antibody responses to SARS-CoV-2 vaccination in a frail sub cohort of older persons living in nursing homes will be determined from 6 months onwards after the last vaccination and related to those of age-matched persons in the DCS.	—

Measure

Time frame

Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month after the first SARS-CoV-2 vaccination. In addition, the possible interference of infection with SARS-CoV-2 in vaccine responsiveness will be determined by measuring serum antibodies to SARS-CoV-2 virus core protein N. Exploratory endpoints: Cellular and serological biomarkers before vaccination will be identified and related to antibody responses to vaccination. Potentially, differences between vaccines might be assessed depending on the vaccines to be used in this age group of study participants in Doetinchem. In addition, antibody responses to SARS-CoV-2 vaccination in a frail sub cohort of older persons living in nursing homes will be determined from 6 months onwards after the last vaccination and related to those of age-matched persons in the DCS.

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Countries

Netherlands

Outcome results