Table 1.
Primary series (months) | Booster schedule (months) | Study group | Month 0 | Month 0.5 | Month 1 | Month 6 | Month 12 | Month 18 | Month 30 | Month 42 | Month 52 | |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Human | 0, 1, 6 | 12, 18, 30, 42 | 7-IM | AVA | Saline | AVA | AVA | AVA | AVA | AVA | AVA | N/A |
0, 1, 6 | 18, 42 | 5-IM | AVA | Saline | AVA | AVA | Saline | AVA | Saline | AVA | N/A | |
0, 1, 6 | 42 | 4-IM | AVA | Saline | AVA | AVA | Saline | Saline | Saline | AVA | N/A | |
NHP | 0, 1, 6 | None | Human dose | AVA | No injection | AVA | AVA | No injection | No injection | Challenge (subset) | No injection | Challenge |
1:5 | AVA | No injection | AVA | AVA | No injection | No injection | Challenge (subset) | No injection | Challenge | |||
1:10 | AVA | No injection | AVA | AVA | Challenge (subset) | No injection | Challenge (subset) | No injection | Challenge | |||
1:20 | AVA | No injection | AVA | AVA | Challenge (subset) | No injection | Challenge | NA | NA | |||
1:40 | AVA | No injection | AVA | AVA | Challenge | NA | NA | NA | NA |
The human and NHP studies have been described in detail previously [9,10]. At each time point, humans received either a full dose of AVA or a saline placebo. NHP received diluted doses of AVA (undiluted, 1/5, 1/10, 1/20 or 1/40) at months 0, 1 and 6. Subsets of NHP were challenged at months 12, 30 and 52 [10,11].