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.

GroupTreatment
assignment
RouteVolumeTiming of
injections
N = 100*N = 105
120 μg of H5-VLP +
2.5 of μg GLA-AF
ID0.2 mlDays 0 and 212020
220 μg of H5-VLP +
2.5 μg of GLA-AF
IM0.2 mlDays 0 and 212023
320 μg of H5-VLP
alone
ID0.2 mlDays 0 and 212022
420 μg of H5-VLP +
1 mg of alhydrogel
IM0.2 mlDays 0 and 212020
590 μg of influenza
virus vaccine, H5N1
(Sanofi Pasteur)
IM1.0 mlDays 0 and 212020

*Planned enrollment.

†Total including replacements.

‡Al+3 content of 1 mg of alhydrogel = 0.5 mg.