Table 2.
Characteristics of patients with breakthrough SARS-CoV-2 infection.
| Characteristics | SARS-CoV-2 infection (n = 266) |
|---|---|
| Prior COVID-19, n/n evaluable (%) | 14/129 (10.8) |
| Type of 1st and 2nd vaccines, n/n evaluable (%) | |
| • Moderna mRNA-1273 | 189/1086 (17.4) |
| • Pfizer-BioNTech BNT162b2 | 68/410 (16.6) |
| • Adenoviral vector-based | 9/55 (16.4) |
| Type of 3rd vaccines before SARS-CoV-2 breakthrough, n evaluable (%) | 185 (69) |
| • Moderna mRNA-1273 | 133 (71.8) |
| • Pfizer-BioNTech BNT162b2 | 50 (27) |
| • Adenoviral vector-based | 2 (1) |
| Likely SARS-CoV-2 variantsa, n (%) | |
| • Alfa or Beta | 18 (6.7) |
| • Delta | 45 (17) |
| • Omicron | 203 (76.3) |
| Age (years), median (range) | 62 (19–97) |
| • 16–40 years, n/n evaluable (%) | 32/167 (19.1) |
| • 41–60 years, n/n evaluable (%) | 97/551 (17.6) |
| • 61–70 years, n/n evaluable (%) | 60/407 (14.7) |
| • >71 years, n/n evaluable (%) | 77/426 (18) |
| Male, n (%)/n evaluable (%) | 165/871 (18.9) |
| Baseline disease, n/n evaluable (%) | |
| • AML | 9/50 (18) |
| • ALL | 0/5 (0) |
| • MDS | 22/117 (18.8) |
| • B cell NHL | 49/260 (18.8) |
| • T cell NHL | 5/15 (33.3) |
| • Plasma cell disorders | 32/164 (19.5) |
| • CLL | 44/155 (26.8) |
| • HD | 9/65 (13.8) |
| • cMPN | 12/127 (9.4) |
| • Aplastic anemia | 0/4 (0) |
| • Non-malignant disorders | 5/17 (29) |
| • Allo-HSCT | 53/429 (12.3) |
| • ASCT | 23/121 (19) |
| • CAR-T | 3/22 (13.6) |
| Immunosuppressant drugs at vaccination, n /n evaluable (%) | 64/322 (19.8) |
| Corticosteroids at vaccination, n /n evaluable (%) | 65/278 (23.3) |
| Daratumumab, n /n evaluable (%) | 11/52 (21.1) |
| Venetoclax, n /n evaluable (%) | 6/16 (37.5) |
| Anti-CD-20 moAb, n /n evaluable (%) | 50/270 (18.5) |
| • <6 months before 1st vaccine dose | 22/97 (22.6) |
| • 6 to 1 year before 1st vaccine dose | 4/25 (16) |
| • >1 year before 1st vaccine dose | 24/148 (16.2) |
| BTK inhibitor therapy, n /n evaluable (%) | 17/67 (25.3) |
| TKI therapy, n /n evaluable (%) | 12/49 (24.5) |
| Lenalidomide, n /n evaluable (%) | 31/129 (24) |
| Ruxolitinib therapy, n /n evaluable (%) | 1/15 (6) |
| Timing and characteristics of breakthrough SARS-CoV-2 infection | |
| SARS-CoV-2 infection after 2 vaccine doses and before booster/s, n (%) | 76 (30) |
| • Median time, days (range) | 158 (7–391) |
| SARS-CoV-2 infection after 3 vaccine doses and before the 4th dose, n (%) | 165 (62) |
| • Median time, days (range) | 121 (1–280) |
| SARS-CoV-2 infection after 4 vaccine doses, n (%) | 25 (8) |
| • Median time, days (range) | 24 (1–115) |
| Number of evaluable SARS-CoV-2 infections after each serological time point, n (%) | |
| • After 3–6 weeks from 2 doses | 240 (90) |
| • After 3 months from 2 doses | 207 (77.8) |
| • After 6 months from 2 doses | 166 (62) |
| • After 1 year from 2 doses | 37 (14) |
| SCoV2-R-A detection at 3–6 weeks, n /n evaluable (%) | 170/240 (70.8) |
| Median SCoV2-R-A titer at 3–6 weeks, BAU/mL (range) | 202 (0–10400) |
| SCoV2-R-A detection at 3 months, n /n evaluable (%) | 137/200 (68.5) |
| Median SCoV2-R-A titer at 3 months, BAU/mL (range) | 99 (0–15846) |
| SCoV2-R-A detection at 6 months, n /n evaluable (%) | 120/161 (74) |
| Median SCoV2-R-A titer at 6 months, BAU/mL (range) | 302 (0–48856) |
| SCoV2-R-A detection at 1 year, n /n evaluable (%) | 27/37 (73) |
| Median SCoV2-R-A titer at 1 year, BAU/mL (range) | 1017 (0–6423) |
| Symptomatic SARS-CoV-2 infection, n /n evaluable (%) | 145/266 (54.5) |
| Pneumonia, n /n evaluable (%) | 49/266 (18.4) |
| Hospital admission, n /n evaluable (%) | 48/266 (18) |
| Oxygen requirement, n /n evaluable (%) | 36/266 (13.5) |
| ICU admission, n /n evaluable (%) | 5/266 (1.9) |
| COVID-related Death, n /n evaluable (%) | 5/266 (1.9) |
| All-cause mortality at median follow-up, n /n evaluable (%) | 12/266 (4.5) |
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, Anti-N SARS-CoV-2 nucleocapsid antibodies, ICU intensive care unit.
aAccording to the Spanish epidemiological data regarding the predominance of each SARS-CoV-2 variant during the time of the study period, we considered Alfa or Beta VOC the episodes of SARS-CoV-2 infection diagnosed between April 1, 2021 and July 26, 2021, Delta VOC between July 27, 2021 and Omicron between December 27, 2021 to July 31, 2022.