Table 2.
Safety profile.
| LD PepGNP-Dengue (n = 10) |
LD vehicle-GNP (n = 3) |
HD PepGNP-Dengue (n = 10) |
HD vehicle-GNP (n = 3) |
|
|---|---|---|---|---|
| Solicited local adverse eventa | ||||
| Grade 1 | 10 (100%) | 3 (100%) | 10 (100%) | 3 (100%) |
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (33%) |
| Solicited systemic adverse eventb | ||||
| Grade 1 | 6 (60%) | 3 (100%) | 8 (80%) | 2 (67%) |
| Grade 2 | 3 (30%) | 0 (0%) | 4 (40%) | 0 (0%) |
| Grade 3 | 0 (0%) | 0 (0%) | 1 (10%) | 0 (0%) |
| Unsolicited local reactionc | ||||
| Grade 1 | 9 (90%) | 3 (100%) | 10 (100%) | 2 (67%) |
| Unsolicited systemic reactionc | ||||
| Grade 1 | 8 (80%) | 2 (67%) | 10 (100%) | 3 (100%) |
| Grade 2 | 3 (30%) | 1 (33%) | 2 (20%) | 2 (67%) |
| Grade 3 | 0 (0%) | 0 (0%) | 1 (10%) | 0 (0%) |
| Adverse event of special interestc | 0 (0%) | 0 (0%) | 3 (30%) | 1 (33%) |
| Serious adverse eventc | 0 (0%) | 1 (33%) | 0 (0%) | 0 (0%) |
| Deathc | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Includes participants with at least one clinical or laboratory adverse event. Data are n (%).
LD = low dose; HD = high dose; GNP = gold nanoparticles.
a
Within 7 days of any injection.
b
Within 14 days of any injection.
c
During the 180-day study follow-up.