Table 2.
Symptoms and vaccine lesion progression.
| BCG |
Placebo |
p |
BCG |
Placebo |
p |
BCG |
Placebo |
p |
BCG |
Placebo |
p |
BCG |
Placebo |
p |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N(%) | T0 | T1 | T2 | T3 | T4 | ||||||||||
| Cough | 54(36.5) | 42(27.8) | 0.141 | 33(22.3) | 30(19.9) | 0.671 | 24(16.2) | 17(11.3) | 0.241 | 18(12.2) | 10(6.6) | 0.111 | 14(9.5) | 9(6) | 0.281 |
| Fever | 2(1.4) | 1(0.7) | 0.621 | 0(0) | 1(0.7) | 11 | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – |
| Chills | 6(4.1) | 4(2.6) | 0.531 | 1(0.7) | 2(1.3) | 11 | 0(0) | 1(0.7) | 11 | 0(0) | 1(0.7) | 11 | 0(0) | 0(0) | – |
| Fatigue | 46(31.1) | 53(35.1) | 0.461 | 24(16.2) | 22(14.6) | 0.751 | 24(16.2) | 13(8.6) | 0.0541 | 20(13.5) | 8(5.3) | 0.0171 | 16(10.8) | 15(9.9) | 0.851 |
| OR = 0.49 (0.22 – 1.05) | OR = 0.36 (0.13–0.89) | ||||||||||||||
| Coryza | 12(8.1) | 9(6.0) | 0.501 | 5(3.4) | 7(4.6) | 0.771 | 8(5.4) | 7(4.6) | 0.801 | 6(4.1) | 2(1.3) | 0.171 | 4(2.7) | 3(2.0) | 0.721 |
| Nasal Congestion | 22 (14.9) | 23 (15.2) | 11 | 8(5.4) | 11(7.3) | 0.641 | 6(4.1) | 7(4.6) | 11 | 3(2.0) | 4(2.6) | 11 | 1(0.7) | 3(2.0) | 0.621 |
| Myalgia | 23(15.5) | 28(18.5) | 0.541 | 13(8.8) | 21(13.9) | 0.201 | 4(2.7) | 12(7.9) | 0.0691 | 10(6.8) | 7(4.6) | 0.461 | 5(3.4) | 3(2.0) | 0.501 |
| Arthralgia | 14(9.5) | 15(9.9) | 11 | 3(2.0) | 11(7.3) | 0.0521 | 1(0.7) | 5(3.3) | 0.211 | 3(2.0) | 3(2.0) | 11 | 1(0.7) | 4(2.6) | 0.371 |
| Headache | 31(20.9) | 31(20.5) | 11 | 24(16.2) | 28(18.5) | 0.651 | 16(10.8) | 16(10.6) | 11 | 14(9.5) | 11(7.3) | 0.531 | 18(12.2) | 9(6.0) | 0.071 |
| Sore throat | 16(10.8) | 23(15.2) | 0.301 | 9(6.1) | 7(4.6) | 0.621 | 5(3.4) | 4(2.6) | 0.741 | 4(2.7) | 6(4.0) | 0.751 | 0(0) | 3(2.0) | 0.241 |
| Anosmia | 70(47.3) | 63(41.7) | 0.351 | 38(25.7) | 56(37.1) | 0.0351 | 32(21.6) | 37(24.5) | 0.591 | 23(15.5) | 30(19.9) | 0.371 | 16(10.8) | 26(17.2) | 0.141 |
| OR = 1.70 (1.01–2.89) | |||||||||||||||
| Ageusia | 59 (39.9) | 49 (32.5) | 0.191 | 35(23.6) | 43(28.5) | 0.361 | 25(16.9) | 31(20.5) | 0.461 | 24(16.2) | 24(15.9) | 11 | 12(8.1) | 18(11.9) | 0.341 |
| Nausea | 9(6.1) | 10(6.6) | 11 | 2(1.4) | 4(2.6) | 0.681 | 1(0.7) | 1(0.7) | 11 | 1(0.7) | 1(0.7) | 11 | 1(0.7) | 0(0) | 0.501 |
| Vomiting | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 1(0.7) | 0(0) | 0.501 | 0(0) | 0(0) | – |
| Diarrhea | 13(8.8) | 5(3.3) | 0.0541 | 3(2.0) | 4(2.6) | 11 | 4(2.7) | 1(0.7) | 0.211 | 2(1.4) | 1(0.7) | 0.621 | 2(1.4) | 0(0) | 0.241 |
| Chest pain | 11(7.4) | 7 (4.6) | 0.341 | 4(2.7) | 2(1.3) | 0.441 | 1(0.7) | 3(2.0) | 0.621 | 1(0.7) | 1(0.7) | 11 | 2(1.4) | 1(0.7) | 0.621 |
| Dyspnea | 20(13.5) | 14(9.3) | 0.281 | 12(8.1) | 4(2.6) | 0.0421 | 6(4.1) | 5(3.3) | 0.771 | 3(2.0) | 4(2.6) | 11 | 4(2.7) | 2(1.3) | 0.441 |
| OR = 0.31 (0.07 – 1.05) | |||||||||||||||
| Somnolence | 13 (8.8) | 17(11.3) | 0.571 | 8(5.4) | 5(3.3) | 0.411 | 5(3.4) | 5(3.3) | 11 | 3(2.0) | 2(1.3) | 0.681 | 3(2.0) | 3(2.0) | 11 |
| Mental confusion | 4(2.7) | 2(1.3) | 0.441 | 2(1.4) | 1(0.7) | 0.621 | 1(0.7) | 1(0.7) | 11 | 1(0.7) | 1(0.7) | 11 | 1(0.7) | 3(2.0) | 0.621 |
| Median number of symptoms | 2 | 2 | 0.451 | 1 | 1 | 0.101 | 1 | 1 | 0.981 | 0 | 0 | 0.361 | 0 | 0 | 0.881 |
| Vaccine lesion | |||||||||||||||
| Erythema | – | 122(82.4) | 1(0.7) | <0.00011 | 117(79.1) | 2(1.3) | <0.00011 | 106(71.6) | 3(2.0) | <0.00011 | 90(60.8) | 0(0) | <0.00011 | ||
| Erythema size | – | 11.4 ± 5.9 | 5.0 | 10.6 ± 4.2 | 1.0 ± 1.4 | 10.0 ± 5.1 | 3.0 ± 1.0 | 7.2 ± 3.0 | |||||||
| Papule | – | 93(62.8) | 1(0.7) | <0.00011 | 60(40.5) | 3(2.0) | <0.00011 | 55(37.2) | 1(0.7) | <0.00011 | 23(15.5) | 0(0) | <0.00011 | ||
| Papule size | – | 10.4 ± 5.4 | 5.0 | 9.2 ± 2.8 | 1.5 ± 2.1 | 9.2 ± 5.4 | 4.0 | 6.9 ± 3.9 | – | ||||||
| Pustule | – | 12(8.1) | 1(0.7) | 0.00141 | 28(18.9) | 0(0) | <0.00011 | 10(6.8) | 0(0) | 0.00081 | 6(4.1) | 0(0) | 0.0141 | ||
| Pustule size | – | 13.4 ± 6.9 | 2.5 | 11.9 ± 5.2 | – | 9.6 ± 3.3 | – | 7.0 ± 9.9 | – | ||||||
| Local Pain | – | 9(6.1) | 0(0) | 0.00161 | 6(4.1) | 0(0) | 0.0141 | 7(4.7) | 0(0) | 0.00681 | 0(0) | 0(0) | – | ||
| Pain size | – | 13.2 ± 6.3 | – | 11.0 ± 1.4 | – | 9.6 ± 4.0 | – | 8.3 ± 3.6 | 5.0 | ||||||
| Itching | – | 19(12.8) | 0(0) | <0.00011 | 11(7.4) | 0(0) | 0.00031 | 12(8.1) | 0(0) | 0.00021 | 7(4.7) | 0(0) | 0.0071 | ||
| Itching size | – | 10.1 ± 5 0.5 |
– | 10.3 ± 0.8 | – | 11.4 ± 5.7 | – | 7.0 ± 1.2 | – | ||||||
| Ulcer | – | 0(0) | 0(0) | – | 2(1.4) | 0(0) | 0.241 | 6(4.1) | 0(0) | 0.0141 | 7(4.7) | 0(0) | 0.0071 | ||
| Ulcer size | – | 15 ± 0 | – | 8.7 ± 2.5 | – | 7.4 ± 1.4 | – | ||||||||
| Crust | – | 3(2.0) | 0(0) | 0.121 | 13(8.8) | 0(0) | <0.00011 | 19(12.8) | 0(0) | <0.00011 | 33(22.3) | 0(0) | <0.00011 | ||
| Crust size | – | 25 ± 0 | – | 8.9 ± 2.4 | – | 9.6 ± 1.6 | – | 7.0 ± 2.0 | – | ||||||
| Scar | – | 0(0) | 0(0) | – | 1(0.7) | 0(0) | 0.501 | 4(2.7) | 2(1.3) | 0.441 | 33(22.3) | 0(0) | <0.00011 | ||
| Scar size | – | 10 | – | 11.7 ± 11.7 | 3.0 ± 0 | 6.7 ± 2.0 | – | ||||||||
| Peeling | – | 2(1.4) | 0(0) | 0.241 | 12(8.1) | 0(0) | 0.00021 | 16(10.8) | 0(0) | <0.00011 | 32(21.6) | 0(0) | <0.00011 | ||
| Peeling size | – | 12 | – | 11.0 ± 2.5 | – | 10.1 ± 5.5 | – | 7.6 ± 3.0 | – | ||||||
| Vesicle | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | ||
| Lymphadenopathy | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | 0(0) | 0(0) | – | ||
| Lesion size overall | – | 10.6 ± 6.4 | 3.3 ± 1.5 | 10.5 ± 4.2 | 3.8 ± 1.5 | 9.7 ± 4.9 | 3.3 ± 1.0 | 6.8 ± 2.9 | 2.0 | ||||||
Legend: 1Wilcoxon rank sum test; p = p-value; BCG = Bacillus Calmette-Guérin; N = number of participants.