SARS-CoV-2 neutralizing antibody | Per-protocol analysis | Intention-to-treat analysis | ||||
---|---|---|---|---|---|---|
0–14 group (n = 256) | 0–21 group (n = 247) | 0–28 group (n = 241) | 0–14 group (n = 270) | 0–21 group (n = 270) | 0–28 group (n = 269) | |
Primary analysis | Â | Â | Â | Â | Â | |
 GMT (95% CI) | 98.4 (88.4–108.4)a | 134.4 (123.1–145.7)b | 145.5 (131.3–159.6)b | 93.5 (83.7–103.3)a | 122.0 (110.7–133.2)b | 129.8 (116.2–143.4)b |
Seroconversion (GMT ≥ 16) |  |  |  |  | ||
 No, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 14 (5.2) | 23 (8.5) | 28 (10.4) |
 Yes, n (%) | 256 (100.0) | 247 (100.0) | 241 (100.0) | 256 (94.8)a | 247 (91.5)ab | 241 (89.6)b |
 Crude OR (95% CI) | – | – | – | 1.0 | 0.6 (0.3–1.2) | 0.5(0.2–0.9) |
 Adjusted OR (95% CI) | – | – | – | 1.0 | 0.6 (0.3–1.2) | 0.5(0.3–1.0) |
Secondary analysis | Â | Â | Â | Â | Â | |
 GMT ≥ 32 |  |  |  |  |  | |
  No, n (%) | 34 (13.3) | 9 (3.6) | 10 (4.1) | 48 (17.8) | 32 (11.8) | 38 (14.1) |
  Yes, n (%) | 222 (86.7)a | 238 (96.4)b | 231 (95.9)b | 222 (82.2) | 238 (88.2) | 231 (85.9) |
  Crude OR (95% CI) | 1.0 | 4.1 (1.9–8.6) | 3.5 (1.7–7.3) | 1.0 | 1.6 (1.0–2.6) | 1.3 (0.8–2.1) |
  Adjusted OR (95% CI) | 1.0 | 4.1 (1.9–8.8) | 3.6 (1.7–7.6) | 1.0 | 1.7 (1.0–2.7) | 1.4 (0.8–2.2) |
 GMT ≥ 64 |  |  |  |  |  | |
  No, n (%) | 100 (39.1) | 38 (15.4) | 46 (19.1) | 114 (42.2) | 61 (22.6) | 74 (27.5) |
  Yes, n (%) | 156 (60.9)a | 209 (84.6)b | 195 (80.9)b | 156 (57.8)a | 209 (77.4)b | 195 (72.5)b |
  Crude OR (95% CI) | 1.0 | 3.5(2.3–5.4) | 2.7(1.8–4.1) | 1.0 | 2.5(1.7–3.6) | 1.9 (1.3–2.8) |
  Adjusted OR (95% CI) | 1.0 | 3.5 (2.7–5.8) | 2.7 (1.8–4.1) | 1.0 | 2.5 (1.7–3.7) | 1.9 (1.4–2.8) |
 GMT ≥ 128 |  |  |  |  |  | |
  No, n (%) | 175 (68.4) | 109 (44.1) | 117 (48.5) | 189 (70.0) | 132 (48.9) | 145 (53.9) |
  Yes, n (%) | 81 (31.6)a | 138 (55.9)b | 124 (51.5)b | 81 (30.0)a | 138 (51.1)b | 124 (46.1)b |
  Crude OR (95% CI) | 1.0 | 2.7 (1.9–3.9) | 2.3 (1.6–3.3) | 1.0 | 2.44 (1.7–3.5) | 2.0 (1.4–2.8) |
  Adjusted OR (95% CI) | 1.0 | 2.7 (1.9–3.9) | 2.3 (1.6–3.4) | 1.0 | 2.43 (1.7–3.5) | 2.1 (1.4–3.0) |
 GMT ≥ 256 |  |  |  |  |  | |
  No, n (%) | 233 (91.0) | 210 (85.0) | 199 (82.6) | 247 (91.5) | 233 (86.3) | 227 (84.4) |
  Yes, n (%) | 23 (9.0)a | 37 (15.0)b | 42 (17.4)b | 23 (8.5)a | 37 (13.7) ab | 42 (15.6)b |
  Crude OR (95% CI) | 1.0 | 1.8 (1.0–3.1) | 2.1 (1.2–3.7) | 1.0 | 1.7 (1.0–3.0) | 2.0 (1.2–3.4) |
  Adjusted OR (95% CI) | 1.0 | 1.8 (1.0–3.2) | 2.3 (1.3–4.0) | 1.0 | 1.8 (1.0–3.1) | 2.1 (1.2–3.6) |