Table 3.
Logistic regression univariate and multivariate analyses of factors predicting SARS-CoV-2 breakthrough infection after full vaccination.
| SARS-CoV-2 infection | P-Value | SARS-CoV-2 infection | P-value | |
|---|---|---|---|---|
| Characteristics | Univariate Fine and Gray (95% C.I.) | Regression Fine and Graya/b HR (95% C.I.) | ||
| Prior to vaccination COVID-19 | 0.04 | |||
| • Yes | 11 (6–17) | 0.6 (0.35–1.02) | 0.06 | |
| • No | 18.4 (16–2) | |||
| Type of vaccine | 0.5 | |||
| • Moderna mRNA-1273 | 17.9 (16–20) | |||
| • Pfizer-BionTech BNT162b2 | 17.6 (14–21) | |||
| • Adenoviral vector-based | 18 (7–30) | |||
| Age (years) | 0.5 | |||
| • 18–40 years | 20.7 (14–27) | |||
| • 41–60 years | 18 (15–22) | |||
| • 61–70 years | 15 (12–19) | |||
| • >71 years | 18.4 (15–22) | |||
| Sex | 0.067 | |||
| • Male | 19.7 (15–20) | |||
| • Female | 15.5 (13–18) | 0.75 (0.58–0.96) | 0.025 | |
| Baseline disease | 0.005 | |||
| • ALL | NT | |||
| • AML | 20 (8–32) | |||
| • MDS | 19.4 (12–27) | |||
| • B cell NHL | 20.2 (15–25) | |||
| • T cell NHL | 33 (9–57) | |||
| • Plasma cell disorders | 20 (14–27) | |||
| • CLL | 29 (20–34) | 1.96 (1.37–2.79) | 0.0002 | |
| • HD | 14 (6–23) | |||
| • cMPN | 9 (3.9–14) | 0.56 (0.31–1) | 0.054 | |
| • Aplastic anemia or non-malignant disorders | 28 (7–49) | |||
| • Allo-HSCT | 13 (10–16) | |||
| • ASCT | 21 (13–28) | |||
| • CAR-T | 14 (0–28) | |||
| Disease status at vaccination | 0.2 | |||
| • Complete remission | 17.2 (15–19.7) | |||
| • Partial remission | 22.5 (16–29) | |||
| • Active disease | 17 (14–21) | |||
| Time from last treatment to COVID-19 vaccine | 0.004 | |||
| • Untreated | 21 (16–26) | |||
| • Under treatment | 22 (18–26) | |||
| • >6 months to 1 year | 16 (10–22) | |||
| • ≥1 year | 14.5 (12–1) | 0.92 (0.85–0.99) | 0.04 | |
| SCoV2-R-A at 3–6 weeks | 0.002 | NT | ||
| • Positive | 16 (14–18) | |||
| • Negative | 25 (20–30) | |||
| SCoV2-R-A in BAU/mL at 3–6 weeks | <0.0001 | NT | ||
| • >250 | 15 (12–18) | |||
| • <250 | 25 (21–28) | |||
| Corticosteroids at vaccination | 0.001 | |||
| • Yes | 24.5 (19–30) | 1.41 (1.05–1.93) | 0.02 | |
| • No | 16.7 (15–19) | |||
| Daratumumab | 0.4 | |||
| • Yes | 21 (10–33) | |||
| • No | 18 (16–20) | |||
| Venetoclax | 0.01 | ns | ||
| • Yes | 38 (14–61) | |||
| • No | 17.9 (16–19.6) | |||
| Anti-CD-20 moAb | 0.5 | |||
| • Yes | 19.5 (15–24) | |||
| • No | 17.5 (14–17.7) | |||
| Bruton’s TKI therapy | 0.07 | ns | ||
| • Yes | 26 (15–37) | |||
| • No | 17.4 (16–19.7) | |||
| TKI therapy | 0.23 | |||
| • Yes | 25 (13–37) | |||
| • No | 18 (16–19.8) | |||
| Lenalidomide | 0.02 | ns | ||
| • Yes | 25 (17–33) | |||
| • No | 17.4 (15–19) | |||
| Ruxolitinib therapy | 0.3 | |||
| • Yes | 7 (0–19) | |||
| • No | 18.2 (16–20) | |||
| Lymphocyte count < 0.5 × 109/L | 0.5 | |||
| • Yes | 16 (6–26) | |||
| • No | 18 (16–20) | |||
| Lymphocyte count < 1.0 × 109/L | 0.3 | |||
| • Yes | 20.6 (16–25) | |||
| • No | 17.4 (15–19.5) |
AL acute leukemia, MDS myelodysplastic syndrome, B-cell NHL B-cell non-Hodgkin lymphoma, MM multiple myeloma, CLL chronic lymphocytic leukemia, HD Hodgkin disease, MPN chronic myeloproliferative neoplasm, Allo-HSCT allogeneic stem cell transplantation, ASCT autologous stem cell transplantation, moAb monoclonal antibody, TKIs tyrosine kinase inhibitors, SCoV2-R-A SARS-CoV-2-reactive IgG antibodies.
aWe carry out the multivariate analysis for Omicron VOC and found that risk factors remain unchanged:
Female gender HR 0.71 (C.I. 95%, 0.53–0.95), p-value 0.024.
LLC Vs others HR 2.01 (C.I. 95%, 1.33–3.04), p-value 0.0009.
Last therapy >1 year HR 0.88 (C.I. 95%, 0.77–1.00), p-value 0.051.
Corticosteroid use HR 1.681 (C.I. 95%, 1.16–2.41), p-value 0.005.
bMultivariate analysis for symptomatic breakthrough SARS-CoV-2 infection:
LLC Vs others HR 2.5 (C.I. 95%, 1.59–3.94), p-value 0.0007.
Last therapy >1 year HR 0.82 (C.I. 95%, 0.71–0.96), p-value 0.018.
Corticosteroid use HR 1.83 (C.I. 95%, 1.2 2.8), p-value 0.005.