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. 2021 Jul 23;9:100178. doi: 10.1016/j.lanepe.2021.100178

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© 2021 The Authors

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

PMC Copyright notice

Fig 1 — Study cohort

* Symptomatic participants = clinical infection, PCR proven ** Asymptomatic participants before 1st vaccination = IgG against Spike S1 ≥ 35•2 BAU/ml or IgG against NCP ≥ 1•1 ratio *** Participants with symptomatic [clinical infection, PCR proven] or asymptomatic [IgG NCP ≥ 1.1 ratio] SARS-CoV-2 infection during or after vaccination period were analyzed separately for the assessment of safety and serological efficacy and are added to the pure vaccination cohort in the corresponding analysis (clinical vaccination cohort). T0 = before first vaccination; T1 = 3–4 weeks after first vaccination; T2 = 4–5 weeks after first vaccination; Analysis of humoral response included measurement of IgA and IgG antibodies against the SARS-CoV-2 S1 protein at time point T0 and additionally IgG antibodies against the novel binding domain S1/RDB of the ACE2 receptor at time point T2. At both time points, additional IgG antibodies against the SARS-CoV-2 nucleocapsid (NCP) were measured. Analysis of the cellular immune response included deep immunophenotyping by FACS analysis and interferon-gamma release assays. Patients in the FACS analysis were all included in the group of IGRA measurements (reciprocal not true). All consented participants from 4 centers adjacent to the study coordination center were selected for IGRA measurement (logistic reasons). The selection took into account the respective number of patients per group (MP/DP/KR) and vaccine type and center. One of the 4 centers with T-cell isolation did not participate in PBMC isolation and thus deep immunophenotyping. For the latter, participants were selected from all 3 groups in which a sufficient number of cells (at least 10⁷/time point and participant) was ensured for the planned analyses at least at the time points T0 and T2 before cryopreservation and after PBMC isolation (technical reasons). BNT162b2 and mRNA-1273 account for the distinct vaccine types. Different indications of numbers stand for the corresponding case numbers in the corresponding subgroups.