TABLE 1.
Humoral and T-cellular response rates 6 months (T3) after the 1st vaccination.
Variable | Category | 3x BNT162b2 | 2x BNT162b2, 1x 1273 | 2x 1273, 1x BNT162b2 | 3x 1273 | 2x mRNA, 1x vector | p_Value | 2x mRNA |
Patient number | N | 57 | 22 | 16 | 63 | 8 | 67 | |
Humoral response | ||||||||
IgG-Ab or IgA-Ab SpikeS1 positive | n of total n (%) | 17/57 (29.8%) | 8/22 (36.4%) | 8/16 (50%) | 31/63 (49.2%) | 1/8 (12.5%) | 0.092 | 11/67 (16.4%) |
IgG-Ab Spike S1 positive | n of total n (%) | 12/57 (21.1%) | 6/22 (27.3%) | 7/16 (43.8%) | 29/63 (46%) | 1/8 (12.5%) | 0.025 | 10/67 (14.9%) |
RBD positive | n of total n (%) | 11/57 (19.3%) | 5/22 (22.7%) | 3/16 (18.8%) | 20/63 (31.7%) | 1/8 (12.5%) | 0.464 | 6/67 (9%) |
IgA-Ab SpikeS1 positive | n of total n (%) | 12/57 (21.1%) | 6/22 (27.3%) | 4/16 (25%) | 21/63 (33.3%) | 1/8 (12.5%) | 0.524 | 7/67 (10.4%) |
Interferon-γ release assay (IGRA)—T-cellular response | ||||||||
IGRA positive | n of total n (%) | 1/16 (6.2%) | 0/7 (0%) | 0/0 (0%) | 6/16 (37.5%) | 1/7 (14.3%) | 0.06 | 5/25 (20%) |
Humoral vaccination responses were assessed as positive when de novo production of the anti-SpikeS1 IgG and (anti-SpikeS1 IgA or IgG endpoint of the original DIA-Vacc study)/or IgA or IgG protein or anti-RBD IgG subunit was above positivity level. A positive T-cellular response to vaccination as assessed by interferon-γ release assay (IGRA) turned from a negative result on T0 to positive on T3, respectively (≥100 mIU/ml, as being recommended by the manufacturers). For this evaluation, all participants with asymptomatic* or documented symptomatic** COVID-19 disease before and during vaccination up to T3 (6 months) were excluded.
BNT162b2 = BNT162b2-mRNA or tozinameran or brand name Comirnaty; 1273 = 1273-mRNA or brand name Spikevax.
*Asymptomatic COVID-19 disease definition–neither knowledge nor symptoms of COVID-19 disease, but IgG-antibody reaction to nucleocapsid (T0, T2, or T3) or the Spike protein subunit S1 (only T0) of the SARS-CoV-2 virus is positive.
**Symptomatic COVID-19 disease definition–SARS-CoV-2 PCR positive patients with clinical symptoms.