Table 3.
Summary of adverse events and BCG lesion by study arm.
| Combined | Jet injector (DSJI) | Needle and syringe (NS) | p-Value | |
|---|---|---|---|---|
| Adults | n = 30 | n = 15 | n = 15 | |
| Total adverse events | 272 | 126 (46.3%) | 146 (53.7%) | p = 0.187 |
| Type of AEs, n (%) | ||||
| Injection site* | 227 (83.5%) | 108 (85.7%) | 119 (81.5%) | p = 0.414 |
| Systemic | 45 (16.5%) | 18 (14.3%) | 27 (18.5%) | |
| Moderate and severe AEs, n (% of total AEs) | 26 (9.6%) | 11 (8.7%) | 15 (10.2%) | p = 0.098 |
| Pain with injection, n (% of total AEs) | 5 (1.8%) | 2 (1.6%) | 3 (2.1%) | p = 0.564 |
| Bleeding at injection site, n (% of total AEs) | 7** (2.6%) | 3 (2.4%) | 4 (2.7%) | p = 0.454 |
| BCG lesion at 12 weeks | ||||
| Ulcer present, n (%) | 25 (83.3) | 12 (80.0%) | 13 (86.7%) | p = 0.690 |
| Scarring present, n (%) | 29 (96.7%) | 15 (100%) | 14 (93.3%) | p = 0.670 |
| Infants | n = 66 | n = 33 | n = 33 | |
| Total adverse events, n | 319 | 158 (49.5%) | 161 (50.5%) | p = 0.475 |
| Type of AEs, n (%) | ||||
| Injection site* | 279 (87.5%) | 138 (87.3%) | 141 (87.6%) | p = 0.949 |
| Systemic | 40 (12.5%) | 20 (12.7%) | 20 (12.4%) | |
| Moderate and severe AEs, n (%) | 24 (7.5%) | 11 (7.0%) | 13 (8.1%) | p = 0.325 |
| Bleeding at injection site, n (%) | 13 (4.0%)** | 7 (4.4%) | 6 (3.7%) | p = 0.665 |
| BCG lesion at 12 weeks | ||||
| Ulcer present, n (%) | 18 (27.3%) | 6 (18.2%) | 12 (36.4%) | p = 0.166 |
| Scarring present, n (%) | 41 (62.1%) | 24 (72.7%) | 17 (51.5%) | p = 0.127 |
p-Values were calculated using Fisher's exact test. % proportions are shown per column category (combined, DSJI, NS).
*
AEs were classified as “injection site reactions” if they occurred at the site of vaccine administration; all other AEs were classified as “systemic.” AEs were recorded 30 min after vaccination and throughout all study visits.
**
All cases of bleeding were mild with drops of blood only.