SARS-CoV-19, frailty
Conditions
Interventions
Trade Name: Comirnaty
Pharmaceutical Form: Suspension for injection
Trade Name: Spikevax
Pharmaceutical Form: Suspension for injection
Trade Name: Vaxzevria
Pharmaceutical Form: Suspension for injec
Sponsors
National Institute for Public Health and the Environment
Eligibility
Sex/Gender
All
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 vaccinations not longer than 1 month in advance for the DC participants or no longer than 7 months ago for nursing home residents. • Willing to sign the Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 325 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1375
Exclusion criteria
Exclusion criteria: • Participant of the DC already received their 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Assess the SARS-CoV-2 vaccine systemic antibody responses in 52+ years old male and female persons in the DC after SARS-CoV-2 (booster) vaccinations. •Determine the kinetics and longevity of SARS-CoV-2 antibody responses based on the data at all timepoints related to frailty in 52-90 years old male and female persons in the DC. •Assess the relation of age, frailty and specific co-morbidities in 52-90 years old male and female persons with antibody responses to SARS-CoV-2 and identifying subgroups of individuals more at risk for lower vaccine responsiveness ;Secondary Objective: •Assess SARS-CoV-2 vaccine systemic antibody responses a month after the first vaccination and compare these data with those at a month after the second vaccination. •Assess possible interference of SARS-CoV-2 infection with vaccine responsiveness. •Booster dose; assess vaccine-specific (Spike-protein-specific) antibody levels pre booster and 28 days till 12 months following booster SARS-CoV-2 vaccination. Exploratory: •Assess numbers of immune cells and the inflammatory status at baseline for their association with age and vaccine responsiveness. •Comparison of antibody responses between different vaccines used. •Antibody responses to SARS-CoV-2 vaccination in a sub cohort of frail elderly living in nursing home, male and female above 50 years of age, will be determined from 6 months onwards after the second vaccination and related to those of age-matched frail persons in the DCS. ;Primary end point(s): Circulating IgG antibodies concentrations (specific for SARS-CoV-2 spike protein), at all timepoints after the second or last primary vaccination (T2-T6), and at all time points after the booster vaccination(s) (B1-D3). Antibody levels will be measured by bead-based multiplex immune assay in blood obtained by finger prick at the different time points. ;Timepoint(s) of evaluation of this end point: 1 month , 3 months, 6 months, 9 months and 1 year post last vaccinatio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Antibody levels specific for SARS-CoV-2 pre vaccination (T0) and at 1 month after the first vaccination (T1) 2. Self-reported experiences with possible SARS-CoV-2 infection from answers to a short questionnaire. 3. Virus-specific serum IgG antibody levels to SARS-CoV-2 Core N protein. 4. Integrated endpoint analysis of all antibody analysis with frailty data and data of specific co-morbidities (subgroups). Exploratory: 1. Absolute numbers of immune cells: lymphocytes, granulocytes and monocytes, in whole EDTA blood pre vaccination T0 or otherwise T1. 2. Inflammatory profiles by measuring biomarkers associated with frailty, such as CRP creatinine and cystatin C in plasma pre vaccination. 3. Antibody responses to SARS-CoV-2 vaccination in a sub cohort of older persons living in nursing homes will be determined from 6 months onwards after the second primary vaccination and related to those of age-matched frail persons in the DCS. ;Timepoint(s) of evaluation of this end point: 1. pre and 1 month after first vaccination 2. pre and 1 month after first vaccination, 1 month , 3 months, 6 months, 9 months and 1 year post last vaccination. 3. pre and 1 month after first vaccination, 1 month , 3 months, 6 months, 9 months and 1 year post last vaccination. 5. pre and 1 month, 6 months and 1 year post booster vaccination. | — |
Countries
Netherlands
Contacts
Public ContactEsther Gijsbers
National Institute for Public Health and the Environment
Outcome results
None listed