Table 3.
Study # | Group | Treatment | Dosage 1 (µg) |
Dosage 2 (µg) |
Dosage 3 (µg) |
Total Dosage (µg) |
---|---|---|---|---|---|---|
1a | 1 | gV3526/CpG | 0.02 | 0.02 | ND | 0.04 |
2 | gV3526/CpG | 0.04 | 0.04 | ND | 0.08 | |
3 | gV3526/ CpG + AlOH | 0.04 | 0.04 | ND | 0.08 | |
4 | gV3526/CpG | 0.4 | 0.4 | ND | 0.8 | |
5 | gV3526/ CpG + AlOH | 0.4 | 0.4 | ND | 0.8 | |
6 | gV3526/ CpG | 0.2 | 0.2 | ND | 0.4 | |
7 | gV3526/ CpG + AlOH | 0.2 | 0.2 | ND | 0.4 | |
8 | gV3526/ CpG | 0.1 | 0.1 | ND | 0.2 | |
9 | gV3526/CpG + AlOH | 0.1 | 0.1 | ND | 0.2 | |
2b | 10 | gV3526/ CpG | 0.27 | 0.27 | 0.27 | 0.81 |
11 | gV3526/ CpG + AlOH | 0.27 | 0.27 | 0.27 | 0.81 | |
12 | gV3526/ CpG | 0.15 | 0.25 | 0.4 | 0.8 | |
13 | gV3526/ CpG + AlOH | 0.15 | 0.25 | 0.4 | 0.8 | |
14 | C-84 | 4 | 4 | 4 | 12 | |
15 | PCMc | 0 | 0 | 0 | 0 |
All vaccinations were performed via the IM route.
Study #1 dosages were administered on days 0 and 28.
Study #2 dosages were administered on days 0, 7 and 28.
PCM was administered on days 0 and 28.
To achieve IM dosages of 0.1, 0.2, and 0.4 µg gV3526, both hind limb muscles were injected with 0.05 mL of inoculum (gV3526, BDS Lot 225). IM vaccination with three escalating dosages (0.15, 0.25, 0.4 µg) and three fixed dosages (0.27 µg) were also administered by injecting both hind limb muscles with 0.05 mL of inoculum.