Monitoring immunogenicity of SARS-Cov-2 vaccination in Dutch middle-aged and older individuals (participating in the Doetinchem Cohort Study)
Phase 4
Recruiting
- Conditions
- immuunsysteemcoronaprevention10047438
- Registration Number
- NL-OMON54058
- Lead Sponsor
- Ministerie van Volksgezondheid, Welzijn en Sport (VWS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1700
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
* DCS Participant already received his second SARS-CoV-2 vaccination more than
1 month before signing the ICF, so sampling at T2 and further is not possible.
* participants living in a nursing home already received both primary
SARS-CoV-2 vaccinations
more than 7 months before signing ICF.
* Incapacitated participants
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month<br /><br>till 12 months following the second SARS-CoV-2 vaccination and post booster<br /><br>vaccinations. Vaccine responses will be related to age, sex, co-morbidities and<br /><br>frailty characteristics.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month<br /><br>after the first SARS-CoV-2 vaccination. In addition, the possible interference<br /><br>of infection with SARS-CoV-2 in vaccine responsiveness will be determined by<br /><br>measuring serum antibodies to SARS-CoV-2 virus core protein N.<br /><br><br /><br>Exploratory endpoints: Cellular and serological biomarkers before vaccination<br /><br>will be identified and related to antibody responses to vaccination.<br /><br>Potentially, differences between vaccines might be assessed depending on the<br /><br>vaccines to be used in this age group of study participants in Doetinchem. In<br /><br>addition, antibody responses to SARS-CoV-2 vaccination in a frail sub cohort of<br /><br>older persons living in nursing homes will be determined from 6 months onwards<br /><br>after the last vaccination and related to those of age-matched persons in the<br /><br>DCS.</p><br>