Table 2.
Day 90 CD4 + response group | Day 90 CD8 + response group | ||||||
---|---|---|---|---|---|---|---|
Responder | Hypo-responder | p-value | Responder | Hypo-responder | p-value | ||
Number of participants, n (%) | 399 (86.4) | 63 (13.6) | 330 (73.5) | 119 (26.5) | |||
Baseline characteristics | |||||||
Age at enrollment, median [Q1,Q3] | 66 [52,71] | 72 [58,78] | 0.002 | 64 [52,70] | 68 [54,76] | 0.015 | |
Age group, n (%) | |||||||
<65 | 192 (89.7) | 22 (10.3) | <0.001 | 166 (77.9) | 47 (22.1) | 0.001 | |
65–74 | 123 (91.8) | 11 (8.2) | 101 (77.7) | 29 (22.3) | |||
≥75 | 84 (73.7) | 30 (26.3) | 63 (59.4) | 43 (40.6) | |||
Sex, n (%) | |||||||
Male | 186 (83.0) | 38 (17.0) | 0.059 | 154 (71.6) | 61 (28.4) | 0.451 | |
Female | 213 (89.5) | 25 (10.5) | 176 (75.2) | 58 (24.8) | |||
Vaccine type, n (%) | |||||||
BNT162b2 | 184 (76.7) | 56 (23.3) | <0.001 | 130 (57.0) | 98 (43.0) | <0.001 | |
mRNA-1273 | 208 (97.7) | 5 (2.3) | 194 (91.5) | 18 (8.5) | |||
ChAdOx1+mRNA | 7 (77.8) | 2 (22.2) | 6 (66.7) | 3 (33.3) | |||
Days between first and second dose, median [Q1,Q3] | 33 [22,35] | 23 [21,27] | <0.001 | 35 [22,35] | 23 [21,28] | <0.001 | |
Days from first vaccine to third study visit, median [Q1,Q3] CCI, n (%) | 91 [88,95] | 91 [89,92] | 0.922 | 91 [88,95] | 91 [88,95] | 0.348 | |
0 | 313 (89.2) | 38 (10.8) | 0.004 | 264 (77.2) | 78 (22.8) | 0.005 | |
1–2 | 72 (79.1) | 19 (20.9) | 55 (63.2) | 32 (36.8) | |||
>2 | 14 (70.0) | 6 (30.0) | 11 (55.0) | 9 (45.0) | |||
Comorbidities in the previous 5 years, n | |||||||
Myocardial infarction | 5 | <5* | 0.587 | <5* | <5* | 0.193 | |
Congestive heart failure | 11 | <5* | 0.694 | 8 | 5 | 0.343 | |
Peripheral vascular disease | <5* | <5* | 0.521 | <5* | <5* | 1.000 | |
Cerebrovascular disease | 16 | <5* | 0.733 | 15 | <5* | 0.423 | |
Dementia | |||||||
Chronic pulmonary disease | 11 | 7 | 0.006 | 11 | 7 | 0.274 | |
Rheumatological disease | 5 | 5 | 0.006 | 8 | <5* | 0.456 | |
Peptic ulcer disease | <5* | 1.000 | <5* | 1.000 | |||
Mild liver disease | 6 | <5* | 0.299 | <5* | 5 | 0.034 | |
Diabetes without chronic complications | 13 | <5* | 0.269 | 11 | 6 | 0.407 | |
Diabetes with chronic complications | <5* | 0.136 | <5* | 0.265 | |||
Hemiplegia or paraplegia | |||||||
Any malignancy, including leukemia and lymphoma | 46 | 9 | 0.531 | 32 | 20 | 0.045 | |
Moderate or severe liver disease | <5* | <5* | 0.445 | <5* | <5* | 0.059 | |
Metastatic solid tumor | <5* | <5* | 0.254 | <5* | <5* | 0.460 | |
AIDS/HIV | 7 | <5* | 0.353 | 6 | <5* | 0.705 | |
Renal disease | <5* | <5* | 0.521 | <5* | <5* | 0.612 | |
Organ transplantation | 23 | <5* | 1.000 | 13 | 13 | 0.010 | |
Day 90 immune response | |||||||
Serological vaccine responder group, n (%) | |||||||
Hypo | 27 (75.0) | 9 (25.0) | 0.006 | 16 (44.4) | 20 (55.6) | <0.001 | |
Moderate | 83 (79.0) | 22 (21.0) | 65 (64.4) | 36 (35.6) | |||
High | 286 (89.9) | 32 (10.1) | 247 (79.9) | 62 (20.1) | |||
Total SARS CoV-2 Spike IgG Antibodies (AU/mL ·105), median [Q1,Q3] | 2.96 [1.08,4.58] | 1.14 [0.48,2.40] | <0.001 | 3.45 [1.54,4.65] | 1.02 [0.44,2.43] | <0.001 | |
Post day 90 | |||||||
Breakthrough Infection, n (%) | |||||||
Yes | 119 (87.5) | 17 (12.5) | 0.766 | 98 (73.1) | 36 (26.9) | 0.907 | |
No | 280 (85.9) | 46 (14.1) | 232 (73.7) | 83 (26.3) | |||
Follow-up days, median [Q1,Q3] | 228 [196,258] | 264 [242,266] | <0.001 | 217 [195,257] | 250 [236,272] | <0.001 |
*Groups with small numbers (<5 participants per cell) where there is the potential that individual participants could be identified or be able to identify themselves have been edited to maintain participant confidentiality.