Table 2.
EU-COVAT-1-AGED – Visit Schedule Part B
| Visit number | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| Procedure | Screening, enrolment, baseline 4th dose | Immune response evaluation | Follow-up | Follow-up | End of study |
| Day ± window | 0 | 14 ±2 days after 4th dose | 3 months ± 3 days after 4th dose | 6 months ± 3 days after 4th dose | 12 months ± 3 days after 4th dose |
| Screening for eligibility | |||||
| Informed consenta | X | ||||
| Demographics and medical historyf | X | ||||
| Eligibility check | X | ||||
| Baseline procedures | |||||
| Concomitant medication review | X | X | |||
| Physical exam | X | Xb | |||
| Vital signs | X | Xb | |||
| Immunogenicity | |||||
| Anti-RBD and anti-N IgG (ELISA) | X | X | X | ||
| Neutralising activity (wild-type)c | X | X | X | ||
| Neutralising activity (VOC)c | X | X | X | ||
| Cellular response (qPCR assay)c | X | X | |||
| Biobankingd | X | X | X | X | X |
| IMP administration | |||||
| Vaccinationg | X | ||||
| Safety | |||||
| AE/SAEe | X | X | X | X | X |
AE adverse events, SAE serious adverse event
aInformed consent must be obtained before obtaining consent for biobanking and secondary data use, and any other procedure to be undertaken.
bWill be performed at visit 2 only upon SAE
cSamples taken from all subjects, analysis performed in a subgroup only. Analysis will be performed in all samples if additional funding becomes available.
dFor secondary use defined in informed consent; also optional at visit 1 and visit 2: at trial site and upon agreement of trial participant additional blood collection for biobanking of peripheral blood mononuclear cells (PBMC) as per informed consent
eSolicited AEs are recorded by trial participant till Day 7 and records will be collected at visit 2 (Day 14) by trial staff and captured in eCRF; unsolicited AEs are recorded by trial investigator until the end of trial as described in this protocol
fMedical history includes information on prior SARS-CoV-2 infection and COVID-19 disease if applicable; name of SARS-CoV-2 variant should be documented if known
gAdministration of 4th vaccination dose after blood sampling for immunogenicity and cellular immunity during visit 1. Trial participant is observed for any adverse reaction for at least 15 min or according to standard of care upon vaccination