Table 1. Treatment assignments.
The table depicts the number of subjects in each group and the treatment regimen, dose, and dose timing for each group. One hundred subjects were enrolled across three study sites and randomly assigned to one of five treatment groups for a total goal of 20 subjects in each of the five groups. An additional five subjects were screened and enrolled to replace five subjects who withdrew from the study for reasons other than dose-limiting toxicity before day 21. A total of 105 subjects were enrolled, as shown in the table.
| Group |
Treatment assignment |
Route | Volume |
Timing
of injections |
N = 100* | N = 105† |
| 1 | 20 μg of H5-VLP + 2.5 of μg GLA-AF |
ID | 0.2 ml | Days 0 and 21 | 20 | 20 |
| 2 | 20 μg of H5-VLP + 2.5 μg of GLA-AF |
IM | 0.2 ml | Days 0 and 21 | 20 | 23 |
| 3 | 20 μg of
H5-VLP alone |
ID | 0.2 ml | Days 0 and 21 | 20 | 22 |
| 4 | 20 μg of H5-VLP + 1 mg of alhydrogel‡ |
IM | 0.2 ml | Days 0 and 21 | 20 | 20 |
| 5 | 90 μg of
influenza virus vaccine, H5N1 (Sanofi Pasteur) |
IM | 1.0 ml | Days 0 and 21 | 20 | 20 |
*Planned enrollment.
†Total including replacements.
‡Al+3 content of 1 mg of alhydrogel = 0.5 mg.