Table 1.
Patient characteristics.
| Characteristics | (n = 1551) |
|---|---|
| Prior COVID-19, n (%) | 129 (8.3) |
| • Median time from COVID-19 to vaccination, days (range) | 203 (11–422) |
| Serological status prior to vaccination, n (%) | |
| • Positive | 64 (4) |
| • Negative | 485 (31) |
| • Not tested | 1002 (65) |
| Type of 1st and/or 2nd vaccine dose, n (%) | |
| • Moderna mRNA-1273 | 1086 (70) |
| • Pfizer-BioNTech BNT162b2 | 410 (26) |
| • Adenoviral vector-based | 55 (4) |
| Type of 3rd vaccine, n (%) | 1275 (82%) |
| • Moderna mRNA-1273 | 910 (71.3) |
| • Pfizer-BioNTech BNT162b2 | 361 (28) |
| • Adenoviral vector-based | 4 (0.7) |
| Age (years), median (range) | 63 (16–97) |
| • 18–40 years, n (%) | 167 (11) |
| • 41–60 years, n (%) | 551 (35.5) |
| • 61–70 years, n (%) | 407 (26) |
| • >71 years, n (%) | 426 (27.5) |
| Male, n (%) | 871 (56.2) |
| Baseline disease, n (%) | |
| • AML | 50 (3.2) |
| • ALL | 5 (0.3) |
| • MDS | 117 (7.5) |
| • B cell NHL | 260 (16.8) |
| • T cell NHL | 15 (1) |
| • Plasma cell disorders | 164 (10.6) |
| • CLL | 155 (10) |
| • HD | 65 (4.2) |
| • cMPN | 127 (8.2) |
| • Aplastic anemia | 4 (0.3) |
| • Non-malignant disorders | 17 (1) |
| • Allo-HSCT | 429 (27.7) |
| • ASCT | 121 (7.8) |
| • CAR-T | 22 (1.4) |
| Status disease at vaccination, n (%) | |
| • Complete remission | 823 (59.3) |
| • Partial remission | 179 (11.5) |
| • Active disease | 453 (29.2) |
| Time last treatment to COVID-19 vaccine, months (range) | |
| • Untreated | 252 (16.2) |
| • Active treatment | 441 (28.4) |
| • ≥6 months to 1 year | 148 (9.5) |
| • ≥1 year | 710 (45.8) |
| Immunosuppressant drugs at vaccination, n (%) | 322 (20.8) |
| Corticosteroids at vaccination, n (%) | 278 (17.9) |
| Daratumumab, n (%) | 52 (3.4) |
| Venetoclax, n (%) | 16 (1) |
| Anti-CD-20 moAb, n (%) | 270 (17.4) |
| • <6 months before 1st vaccine dose | 97 (6.3) |
| • 6 to 1 year before 1st vaccine dose | 25 (1.6) |
| • >1 year before 1st vaccine dose | 148 (9.5) |
| BTK inhibitor therapy, n (%) | 67 (4.3) |
| TKI therapy, n (%) | 49 (3.2) |
| Lenalidomide maintenance, n (%) | 129 (8.3) |
| Ruxolitinib therapy, n (%) | 15 (1) |
| Blood count before vaccination (×109/mL) | |
| • Absolute neutrophile counts, median (range) | 3.1 (0–46.7) |
| • Absolute lymphocyte counts, median (range) | 1.73 (0.14–262.1) |
| • Absolute lymphocyte counts <1 × 109/L | 288 (18.6) |
| Median time between 1st and 2nd vaccine doses, median days (range) | 28 (17–115) |
| Time from 2nd dose to first serologies, median days (range) | 21 (12–62) |
| Serological response at 3 weeks after 2 doses, n (%) | |
| • Positive | 1092 (70.4) |
| • negative | 306 (19.7) |
| • Not available | 153 (10) |
| Third vaccine dose given, n (%) | 1284 (82.8) |
| Time from 2nd dose to 3rd dose, days (range) | 168 (31–538) |
| Median follow-up after 3 doses, days (range) | 189 (0–302) |
| Serological response after 3 doses, n (%) | |
| • Positive | 251 (19) |
| • negative | 72 (5.6) |
| • Not available | 961 (75) |
| Forth vaccine dose, n (%) | 430 (27.7) |
| Time from 3rd dose to 4th dose, days (range) | 159 (31–266) |
| Median follow-up after 4 doses, days (range) | 12 (0–95) |
| SCoV2-R-A detection at 3–6 weeks after 2 vaccine doses, n/evaluable (%) | 1090/1398 (78) |
| • Antibody titers in BAU/mL, n (%) | 1250 (89) |
| SCoV2-R-A detection at 3 months after 2 vaccine doses, n (%) | 922/1174 (78) |
| • Antibody titers in BAU/mL, n (%) | 1070 (91) |
| SCoV2-R-A detection at 6 months after full vaccination, n (%) | 842/1023 (82) |
| • Antibody titers in BAU/mL, n (%) | 900 (88) |
| SCoV2-R-A detection at 1 year after full vaccination, n (%) | 740/849 (87) |
| • Antibody titers in BAU/mL, n (%) | 820 (97) |
| Breakthrough COVID-19, n (%) | 266 (17) |
| Median time from 2 doses of vaccine to SARS-CoV-2 infection, days (range) | 86 (7–391) |
| Median follow-up whole cohort, days (range) | 388 (47–561) |
| All-cause mortality at median follow-up, n (%) | 89 (5.7) |
PCR polimerase chain reaction, AML acute myeloid leukemia, ALL acute lymphoblastic leukemia, MDS myelodysplastic syndrome, B-cell NHL B-cell non-Hodgkin lymphoma, T cell NHL T cell non-hodgkin lymphoma, CLL chronic lymphocytic leukemia, HD Hodgkin disease, MPN chronic myeloproliferative neoplasm, Allo-HSCT allogeneic stem cell transplantation, ASCT autologous stem cell transplantation, CAR-T T-cell chimeric antigen receptor, moAb monoclonal antibody, BTK inhibitor Bruton’s tyrosine kinase inhibitor, TKIs tyrosine kinase inhibitors, SCoV2-R-A SARS-CoV-2-reactive IgG antibodies.