Table 1.
Patient characteristics.
| Characteristics | Allo-SCT (n = 429) | ASCT (n = 121) | CAR-T (n = 22) |
|---|---|---|---|
| COVID-19 pre-vaccination, n (%) | 37 (8.5) | 9 (7.4) | 0 |
| Serology pre-vaccination, n (%) | 237 (55) | 35 (29) | 16 (72.7) |
| • Positive, n (%) | 16 (6.7) | 7 (20) | 0 |
| Type of vaccine, n (%) | |||
| • Moderna mRNA-1273 | 349 (81.3) | 87 (72) | 20 (90) |
| • Pfizer-BioNTech BNT162b2 | 71 (16.6) | 24 (20) | 2 (10) |
| • Adenoviral vector-based | 9 (2.1) | 9 (8) | 0 |
| 3rd vaccine and type, n (%) | 357 (83.2) | 106 (87.6) | 19 (86.4) |
| • Moderna mRNA-1273 | 64 (18) | 29 (27) | 4 (21) |
| • Pfizer-BioNTech BNT162b2 | 292 (82) | 75 (73) | 15 (79) |
| • Adenoviral vector-based | 0 | 0 | 0 |
| Age (years), median (range) | 55 (16-78) | 61 (19-79) | 59 (26-78) |
| • 18–40 years, n (%) | 91 (21.2) | 9 (7.4) | 3 (13.6) |
| • 41–60 years, n (%) | 205 (47.8) | 49 (40.5) | 15 (68.3) |
| • 61–70 years, n (%) | 107 (24.9) | 50 (41.4) | 3 (13.6) |
| • >71 years, n (%) | 26 (6.1) | 13 (10.7) | 1 (4.5) |
| Male, n (%) | 246 (57.3) | 69 (57) | 13 (59) |
| Baseline disease, n (%) | |||
| • AML | 151 (35.2) | 5 (4.1) | |
| • MDS | 58 (13.5) | ||
| • NHL | 68 (15.8) | 26 (21.4) | 13 (59.2) |
| • MM | 11 (2.5) | 73 (60.4) | 7 (31.8) |
| • CLL | 8 (2) | 1 (4.5) | |
| • HD | 42 (9.8) | 17 (14.1) | |
| • MPN | 27 (6.3) | ||
| • ALL | 49 (11.4) | 1 (4.5) | |
| • Others | 15 (3.5) | ||
| Status disease at vaccination, n (%) | |||
| • Complete remission | 387 (90.2) | 87 (71.8) | 17 (77.3) |
| • Partial remission | 13 (3) | 22 (18.2) | 2 (9.1) |
| • Not responding | 29 (6.8) | 12 (10) | 3 (13.6) |
| Median time from transplant to COVID-19 vaccine, months (range) | 33 (2–317) | 36 (3–305) | 9.6 (4.4–23.5) |
| • <6 months | 55 (12.8) | 13 (10.7) | 3 (13.6) |
| • ≥6 months to 1 year | 57 (13.3) | 14 (11.6) | 9 (40.9) |
| • ≥1 year | 317 (73.9) | 94 (77.7) | 10 (45.5) |
| CAR-T cell type | |||
| • Axi-cell | 11 | ||
| • Tisa-cell | 4 | ||
| • Anti-BCMA | 5 | ||
| • Academic anti-CD19 | 2 | ||
| Conditioning Regimen, n (%) | |||
| • Melphalan | 73 (60) | ||
| • BEAM | 48 (40) | ||
| • BUCY | 12 (2.8) | ||
| • TBF | 144 (3.6) | ||
| • TBI-based | 40 (9.3) | ||
| • FluBuCy | 41 (9.6) | ||
| • FluBu | 123 (8.7) | ||
| • FluMel | 37 (8.6) (9) | ||
| • FluCy | 7 (1.6) | ||
| • Others | 25 (5.8) | ||
| Allo-SCT, n (%) | |||
| • HLA identical sibling donor | 170 (39.6) | ||
| • URD | 146 (34) | ||
| • Haplo-identical family donor | 106 (24.7) | ||
| • UCBT | 6 (1.7) | ||
| Donor/recipient HLA mismatch, n (%) | 132 (30.7) | ||
| GvHD prophylaxis | |||
| • Post-Cy based | 218 (50.8) | ||
| • Sirolimus based | 152 (35.4) | ||
| • CNI based | 277 (64.6) | ||
| ATG-based conditioning regimen, n (%) | 24 (5.5) | ||
| Conditioning regimen intensity, n (%) | |||
| • MAC | 175 (40.8) | ||
| • RIC | 253 (59.2) | ||
| IS drugs at vaccination, n (%) | 164 (38.2) | 36 (29.8) | 0 |
| IS without corticosteroids, n (%) | 123 (28.7) | 17 (14) | 0 |
| Corticosteroids at vaccination, n (%) | 36 (8.4) | 40 (33) | 0 |
| Active GvHD at vaccination, n (%)* | 121 (28.2) | ||
| • Acute GvHD | 8 (1.9) | ||
| • Chronic GvHD | 113 (26.3) | ||
| Lenalidomide maintenance, n (%) | 3 (0.7) | 150 (41.3) | |
| Ruxolitinib as GvHD therapy | 24 (5.6) | ||
| Blood count before vaccination (x109/mL) | |||
| • Absolute neutrophile counts, median (range) | 2.92 (0.06–11.57) | 2.7 (0.44–15.4) | .12 0.5–6.3) |
| • Absolute lymphocyte counts, median (range) | 1.95 (0.28–19.4) | 1.49 (0.65–5.4) | 1.27 (0.44–4.6) |
| Time from 2° dose to first serologies, median days (range) | 21 (15–51) | 22 (15–53) | 22 (20–46) |
| Median time between 1st and 2nd vaccine doses, median days (range) | 28 (18–88) | 28 (20–76) | 28 (28–31) |
| Time from 2nd dose to 3rd dose, days (range) | 161 (31–390) | 149 (69–538) | 182 (122–253) |
| Median follow-up after 3 doses, days (range) | 187 (9–289) | 194 (8–302) | 172 (36–268) |
| Forth vaccine dose, n (%) | 130 (30.3) | 50 (41) | 7 (31.8) |
| Time from 3rd dose to 4th dose, days (range) | 160 (108–246) | 161 (151–266) | 155 (147–259) |
| Median follow-up after 4 doses, days (range) | 39 (1–143) | 42 (15–107) | 47 (0–86) |
| SARS-CoV-2-S-RA detection at 3-6 weeks after 2 vaccine doses, n/evaluable (%) | 295/373 (79) | 93/112 (83) | 12/21 (57) |
| • Available antibody titers in BAU/mL, n (%) | 309 (82) | 101 (90) | 20 (91) |
| SARS-CoV-2-S-RA detection at 3 months after 2 vaccine doses, n/evaluable (%) | 270/321 (84) | 76/91 (83) | 10/17 (59) |
| • Available antibody titers in BAU/mL, n (%) | 303 (94.3) | 80 (88) | 17 (100) |
| SARS-CoV-2-S-RA detection at 6 months after full vaccination, n/evaluable (%) | 240/262 (92) | 65/75 (86.6) | 13/21 (62) |
| • Available antibody titers in BAU/mL, n (%) | 256 (98) | 53 (81) | 18 (100) |
| SARS-CoV-2-S-RA detection at 1 year after full vaccination, n/evaluable (%) | 210/217 (97) | 52/60 (87) | 9/16 (56) |
| • Available antibody titers in BAU/mL, n (%) | 217 (100) | 59 (98) | 16 (100) |
| COVID-19 after vaccination, n (%) | 53 (12.4) | 23 (19) | 3 (13.6) |
| Median time from 2nd dose of vaccine to SARS-CoV-2 infection, days (range) | 405 (15–517) | 398 (171–477) | 368 (368–420) |
| All-cause mortality n (%) | 9 (2.1) | 5 (4.1) | 0 |
| Median time from vaccination to death, days (range) | 235 (15–286) | 325 (104–416) | |
| Median follow-up from 1st dose, days (range) | 380 (49-517) | 380 (66–561) | 402 (219–436) |
AML means acute myeloid leukemia, MDS myelodysplastic syndrome, NHL non-Hodgkin lymphoma, MM multiple myeloma, CLL chronic lymphocytic leukemia, HD Hodgkin disease, MPN chronic myeloproliferative neoplasm, ALL acute lymphoblastic leukemia, BEAM BCNU, etoposide, cytarabine and melphalan, TBF thiotepa, fludarabine and busulphan, TBI total body irradiation, FluBuCy fludarabine, busulphan and cyclophosphamide, FluMel fludarabine and melphalan, Allo-HSCT allogeneic stem cell transplantation, URD adult unrelated donor, UCBT umbilical cord blood transplantation, Post-Cy post-transplant cyclophosphamide, CNI calcineurin inhibitor, ATG anti-thymocyte globulin, MAC myeloablative conditioning, RIC reduced intensity conditioning, IS Immunosuppressors, GvHD graft versus host disease, SARS-CoV-2-S-RA SARS-CoV-2-reactive antibody.
*121 recipients had active GvHD at the time of vaccination, of them 46 (38%) had mild GvHD with no IS requirement whereas 49 (40%) and 26 (21%) were on IS w/o or with corticosteroids, respectively.