Table 3.
Local BCG injection site reactions, by prior BCG vaccination history.
| Total BCG (Stage 1 & 2) | BCG-naïve | BCG-revaccination | p-value | |
|---|---|---|---|---|
| n = 3379 | n = 1127 | n = 2252 | ||
| Pain | 1549 (45.8%) | 399 (35.4%) | 1150 (51.0%) | <0.001 |
| None | 1830 (54.2%) | 728 (64.6%) | 1102 (49.0%) | |
| Grade 1 | 1262 (37.4%) | 312 (27.7%) | 950 (42.1%) | 0.2a |
| Grade 2 | 268 (7.9%) | 82 (7.3%) | 186 (8.3%) | |
| Grade 3 | 16 (0.5%) | 4 (0.4%) | 12 (0.5%) | |
| Grade 4 | 3 (0.1%) | 1 (0.1%) | 2 (0.1%) | |
| Onset, days | 2 (1–3) | 2 (1–3) | 2 (1–3) | 0.5 |
| Duration, days | 5 (2–9) | 3 (2–9) | 5 (3–9) | <0.001 |
| Tenderness | 2312 (68.4%) | 797 (70.6%) | 1515 (67.3%) | 0.04 |
| None | 1067 (31.6%) | 330 (29.3%) | 737 (32.7%) | |
| Grade 1 | 1686 (49.9%) | 610 (54.1%) | 1076 (47.8%) | <0.001a |
| Grade 2 | 484 (14.3%) | 161 (14.3%) | 323 (14.3%) | |
| Grade 3 | 139 (4.1%) | 25 (2.2%) | 114 (5.1%) | |
| Grade 4 | 3 (0.1%) | 1 (0.1%) | 2 (0.1%) | |
| Onset, days | 2 (1–3) | 2 (1–3) | 2 (1–2) | 0.8 |
| Duration, days | 8 (4–14) | 7 (3–14) | 8 (4–13) | 0.5 |
| Erythema | 3101 (91.7%) | 976 (86.6%) | 2125 (94.4%) | <0.001 |
| None | 278 (8.3%) | 151 (13.4%) | 127 (5.6%) | |
| Grade 1 | 2997 (88.7%) | 954 (84.7%) | 2043 (90.7%) | 0.05a |
| Grade 2 | 99 (2.9%) | 21 (1.9%) | 78 (3.5%) | |
| Grade 3 | 5 (0.2%) | 1 (0.1%) | 4 (0.2%) | |
| Grade 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Onset, days | 2 (1–2) | 2 (1–2) | 2 (1–2) | <0.001 |
| Mean [SD] | 2.1 [2.4] | 2.5 [3.3] | 2.0 [1.8] | |
| Duration, days | 13 (10–14) | 14 (10–30) | 13 (10–14) | <0.001 |
| Mean [SD] | 22.2 [26.5] | 28.4 [31.1] | 19.4 [23.6] | |
| Maximal diameter, cm | 1.5 (1.0, 2.0) | 1.0 (1.0, 2.0) | 1.5 (1.0, 2.4) | <0.001 |
| Mean [SD] | 1.9 [1.4] | 1.7 [1.4] | 2.0 [1.4] | |
| Swelling | 2539 (75.1%) | 725 (64.3%) | 1814 (80.5%) | <0.001 |
| None | 840 (24.9%) | 402 (35.7%) | 438 (19.5%) | |
| Grade 1 | 2243 (66.3%) | 635 (56.3%) | 1608 (71.4%) | 0.6a |
| Grade 2 | 282 (8.3%) | 87 (7.7%) | 195 (8.7%) | |
| Grade 3 | 14 (0.4%) | 3 (0.3%) | 11 (0.5%) | |
| Grade 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Onset, days | 2 (1–3) | 2 (1–3) | 2 (1–3) | <0.001 |
| Mean [SD] | 2.8 [3.5] | 3.3 [3.6] | 2.7 [3.4] | |
| Duration, days | 10 (5–14) | 11 (4–21) | 9 (5–13) | <0.001 |
| Mean [SD] | 14.1 [17.6] | 18.8 [22.6] | 12.3 [14.7] | |
| Maximal diameter, cm |
1.0 (0.5, 2.0) |
1.0 (0.7, 2.0) |
1.0 (0.5, 2.0) |
0.5 |
| Total BCG (Stage 1 & 2) | BCG-naïve | BCG-revaccination | ||
| |
n = 3122 |
n = 1018 |
n=2104 |
|
| Itch* | 1535 (49.2%) | 472 (46.4%) | 1063 (50.5%) | |
| None | 1587 (50.8%) | 546 (53.6%) | 1041 (49.5%) | |
| Grade 1 | 1474 (47.2%) | 441 (43.2%) | 1033 (49.1%) | 0.001a |
| Grade 2 | 61 (2.0%) | 31 (3.1%) | 30 (1.4%) | |
| Grade 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Grade 4 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Onset, days | 3 (2–7) | 4 (2–7) | 3 (2–7) | 0.2 |
| Duration, days | 10 (5–20) | 10 (5–15) | 10 (5–20) | 0.5 |
BCG recipients in Stage 1 and Stage 2. Data are presented as n (%) or median (interquartile range), unless otherwise specified.
*Itch evaluated in 6-month follow-up questionnaire.
ap-value comparing reaction severity Grades 1 to 4, between BCG-naïve and BCG-revaccination groups.