Table 1.
Design of the HeV-sG vaccine (HeV-sG-V) efficacy study 1.
| Group | Treatment | Prime (Day 0) | Boost (Day 28) | |||
|---|---|---|---|---|---|---|
| Dose (mg) | Volume (mL) | Dose (mg) | Volume (mL) | Challenge virusa (Day 56) | ||
| Control (n = 6) | Alhydrogelb | 0 | 1 | 0 | 1 | HeV (n = 3) NiV (n = 3) |
| Single dose (n = 6) | HeV-sG-Vc | 0.3 | 3d | None | n/a |
HeV (n = 3) NiV (n = 3) |
|
Prime/boost (n = 12) |
HeV-sG-Vc | 0.1 | 1 | 0.1 | 1 |
HeV (n = 6) NiV (n = 6) |
aThe challenge virus was delivered intratracheally.
bControl was Alhydrogel diluted to contain 1.0 mg/mL Al3+ aluminum hydroxide suspension.
cHeV-sG-V contains 0.1 mg/mL HeV-sG in 1.0 mg/mL Al3+ aluminum hydroxide suspension.
dThe 3.0 mL dosing volume was administered as 3 × 1 mL injections, intramuscularly to lumbar and thighs bilaterally. The 1 mL dose was delivered as a single injection.
Total 6 groups were created from 24 AGMs—3 duplet groups, HeV or NiV-B challenge group in each duplet. The two control groups (3 subjects per group) received a placebo on days 0 and 28. The two single-dose groups (3 subjects per group) received 0.3 mg HeV-sG in 3.0 ml HeV-sG-V on day 0. The two prime/boost groups (6 subjects per group) received 0.1 mg HeV-sG in 1.0 ml HeV-sG-V on day 0 and the same quantities repeated on day 28. All subjects were challenged on day 56 with the respective HeV or NiV-B. Animals were studies for another 28 days and euthanized on day 84.