Table 2.
Solicited adverse reactions for 7 days after first or second vaccinations, and unsolicited adverse reactions until day 56, graded by US Food and Drug Administration criteria in phase 1
| 5 μg group (n=20) | 10 μg group (n=20) | 15 μg group (n=20) | 20 μg group (n=20) | 25 μg group (n=16)* | Placebo group (n=20)† | p value | |
|---|---|---|---|---|---|---|---|
| Solicited adverse reactions | |||||||
| Any | 12 (60%) | 16 (80%) | 19 (95%) | 19 (95%) | 16 (100%) | 1 (5%) | <0·0001 |
| Grade 3 | 0 | 3 (15%) | 6 (30%) | 8 (40%) | 6 (38%) | 0 | 0·0005 |
| Injection site adverse reactions | |||||||
| Any | 8 (40%) | 14 (70%) | 16 (80%) | 19 (95%) | 14 (88%) | 1 (5%) | <0·0001 |
| Grade 3 | 0 | 0 | 0 | 1 (5%) | 0 | 0 | 1·0 |
| Pain | 6 (30%) | 13 (65%) | 14 (70%) | 18 (90%) | 12 (75%) | 1 (5%) | <0·0001 |
| Redness | 3 (15%) | 4 (20%) | 9 (45%) | 8 (40%) | 9 (56%) | 0 | 0·0012 |
| Swelling | 1 (5%) | 0 | 2 (10%) | 3 (15%) | 5 (31%) | 0 | 0·046 |
| Induration | 0 | 1 (5%) | 3 (15%) | 6 (30%) | 6 (38%) | 0 | 0·0019 |
| Itch | 2 (10%) | 1 (5%) | 3 (15%) | 5 (25%) | 3 (19%) | 0 | 0·19 |
| Systemic adverse reactions | |||||||
| Any | 10 (50%) | 15 (75%) | 18 (90%) | 19 (95%) | 16 (100%) | 0 | <0·0001 |
| Grade 3 | 0 | 3 (15%) | 6 (30%) | 7 (35%) | 5 (31%) | 0 | 0·0013 |
| Fever | 1 (5%) | 13 (65%) | 17 (85%) | 19 (95%) | 16 (100%) | 0 | <0·0001 |
| Headache | 5 (25%) | 5 (25%) | 9 (45%) | 11 (55%) | 9 (56%) | 0 | 0·0004 |
| Fatigue or malaise | 8 (40%) | 8 (40%) | 7 (35%) | 6 (30%) | 9 (56%) | 0 | 0·0024 |
| Joint pain | 1 (5%) | 5 (25%) | 1 (5%) | 5 (25%) | 2 (13%) | 0 | 0·046 |
| Muscle pain | 3 (15%) | 8 (40%) | 3 (15%) | 5 (25%) | 5 (31%) | 0 | 0·022 |
| Chills | 0 | 3 (15%) | 0 | 7 (35%) | 2 (13%) | 0 | 0·0006 |
| Nausea | 3 (15%) | 2 (10%) | 2 (10%) | 1 (5%) | 2 (13%) | 0 | 0·60 |
| Diarrhoea | 1 (5%) | 2 (10%) | 4 (20%) | 2 (10%) | 2 (13%) | 0 | 0·40 |
| Vomiting | 1 (5%) | 0 | 1 (5%) | 1 (5%) | 2 (13%) | 0 | 0·38 |
| Unsolicited adverse reactions‡ | |||||||
| Any | 18 (90%) | 20 (100%) | 19 (95%) | 19 (95%) | 16 (100%) | 12 (60%) | 0·0003 |
| Fever | 0 | 0 | 0 | 1 (5%) | 0 | 0 | 1·0 |
| Low lymphocyte count | 11 (55%) | 20 (100%) | 17 (85%) | 18 (90%) | 15 (94%) | 2 (10%) | <0·0001 |
| Grade 3 | 0 | 2 (10%) | 4 (20%) | 3 (15%) | 2 (13%) | 0 | 0·14 |
| CRP increased | 2 (10%) | 2 (10%) | 2 (10%) | 1 (5%) | 2 (13%) | 1 (5%) | 0·97 |
| Injection site discomfort | 1 (5%) | 0 | 0 | 0 | 0 | 0 | 1·0 |
| Neutrophil decreased | 0 | 2 (10%) | 2 (10%) | 5 (25%) | 2 (13%) | 0 | 0·065 |
| Cough | 0 | 0 | 1 (5%) | 2 (10%) | 0 | 0 | 0·43 |
| URI | 2 (10%) | 2 (10%) | 0 | 1 (5%) | 1 (6%) | 2 (10%) | 0·87 |
| UTI | 2 (10%) | 2 (10%) | 1 (5%) | 3 (15%) | 2 (13%) | 1 (5%) | 0·97 |
| Albuminuria | 0 | 3 (15%) | 2 (10%) | 2 (10%) | 1 (6%) | 1 (5%) | 0·72 |
Data are n (%). CRP=C-reactive protein. URI=upper respiratory tract infection. UTI=urinary tract infection.
*
Four participants withdrew.
†
Participant data taken from all five blocks.
‡
Until day 56 related to investigational vaccine.