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COVID-19 vaccine in patients with CLL
variables (e.g., white blood cell count and absolute lym- phocyte count), then LASSO tends to select one variable from this set and ignore the others. This helps to avoid selection bias and poor predictive performance in relative- ly small datasets17 and is therefore very useful in medical applications.20,21
Results
A total of 400 patients with CLL were recruited into the trial from nine medical institutes in Israel between December 2020 and February 2021. Our vaccine response analysis is based on the data obtained from 373 patients after excluding the following patients: 14 patients whose serology tests were taken too early (<12 days after the sec- ond dose), one patient who had received the Moderna vac- cine, nine patients whose antibody tests were not collected and three patients who were infected by SARS-CoV-2 after vaccination. Blood samples were analyzed 2-3 weeks (median 19 days; range, 12-53) after the patients had received the second dose of the vaccine.
The median age of the entire cohort was 70 years old (range, 40-89), and 222 (58.9%) were male. The median time since diagnosis of CLL was 83 months for the whole
cohort, and 66 months and 97 months in patients with or without a serological response, respectively. (Table 1)
Side effects of the vaccine
Figure 1 and Online Supplementary Table S1 provide details of adverse events following administration of the BNT162b2 mRNA COVID-19 vaccine to patients with CLL. Patients were asked about the development of fever, rash, pain at the site of injection or generalized muscle pain. Of the 331 patients who answered the questionnaire, 180 (54.4%) reported no side effects following the two doses of the vaccine. All side effects that were reported were either grade 1 (41.7%) and/or grade 2 (4%). The most frequent was local pain at the site of injection, which was reported by 32.3% of the cohort. The most frequent grade 2 side effects were pain and fever, reported by 4.3% and 3.6% of the patients, respectively. Other side effects of interest noted by the investigators included one case of facial numb- ness lasting for 12 h, which resolved without sequelae. In the open question of the questionnaire 12 patients reported fatigue, and eight complained of headache. Two patients developed autoimmune hemolytic anemia, which was detected on the day of the serology test at 18 and 35 days after the second vaccine with hemoglobin levels of 5.6 mg/dL and 4.71 mg/dL, respectively. Both patients were in
Table 1. Clinical and demographic parameters and efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia.
Variable
Median age in years (range) ≤ 70 years, n (%)
> 70 years, n (%)
Sex, n (%) Female Male
Median time since CLL diagnosis in months (range)
Binet Stage,* n (%) A
B C
Diabetes mellitus, n (%) No
Yes
Ischemic heart disease, n (%) No
Yes
Hypertension, n (%) No
Yes
R-CIRS, median (range) <6, n (%)
≥6, n (%)
Lymphadenopathy, n (%) No
Yes
Splenomegaly, n (%) No
Yes
Serological response
Total Odds ratio (95% CI)
n=373
<0.001 165 0.65 (0.43-0.98) 0.04
151 1 (ref)
222 0.99 (0.65-1.5) 0.96
<10-4
113 1 (ref)
29 0.41 (0.18-1.1) 0.06
9 0.41 (0.1-1.6) 0.19
296 1 (ref)
77 0.761 (0.45-1.27) 0.3
319 1 (ref)
54 0.7521 (0.41-1.36) 0.35
239 1 (ref)
134 0.8885 (0.58-1.36) 0.59
P-value
Positive n=160 (43%)
69 (40-88) 99 (48%) 61 (37%)
65 (43%) 95 (43%)
66 (1-362)
75 (66%) 13 (45%) 4 (44%)
131 (44%) 29 (38%)
140 (44%) 20 (37%)
105 (44%) 55 (41%)
4 (0-11) 84 (48%) 54 (36%)
41 (41%) 32 (38%)
47 (39%)
11 (31%)
Negative n=213 (57%)
71 (44-89) 109 (52%) 104 (63%)
86 (57%) 127 (57%)
97 (3-341)
38 (34%) 16 (55%) 5 (56%)
165 (56%) 48 (62%)
179 (56%) 34 (63%)
134 (56%) 79 (59%)
5 (0-19) 91 (52%) 98 (64%)
60 (59%) 53 (62%)
73 (61%)
24 (69%)
208 1 (ref)
0.004 152 0.5969 (0.38-0.93) 0.02
101 1 (ref)
85 0.8836 (0.49-1.6) 0.68
120 1 (ref)
35 0.7119 (0.32-1.59) 0.41
175 1 (ref)
*Binet stage is at time of vaccination only for treatment-naïve patients.95% CI:95% confidence interval;CLL:chronic lymphocytic leukemia;CIRS:Cumulative Illness Rating Scale.
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