Table 2. Experimental Procedures and Schedule.
| Study Day | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Procedure | Pre | 0 | 7 | 14 | 21 | 28 | 35 | 42 | Pre | 70 | 71 | 72 | 73 | 74 | 84 |
| Clinical Observations a | X | ← X (2x daily) → | X (3x daily) X | ||||||||||||
| Body Weight b | X | ← X (weekly) → | |||||||||||||
| Vaccination c | X | X | |||||||||||||
| Blood (ELISA, TNA) d | X | X | X | X | X | X | |||||||||
| Challenge e | X | ||||||||||||||
| Blood (Hematology) f | X | X | X | X | |||||||||||
| Blood (Clin.Chem.) g | X | X | X | X | |||||||||||
| Blood (Bacteriology) h | X | X | X | X | X | X | |||||||||
| Blood (ECL) i | X | X | X | X | X | X | |||||||||
| Target Blood Volume (mL) | 5 | 5 | 5 | 5 | 8 | 2 | 4 | 2 | 4 | 9 | |||||
| Necropsy | X j | X k | |||||||||||||
aThrice daily observations performed on Days 72–74. Twice daily observations performed other days.
bBody weight obtained at randomization, on Day 0 and weekly thereafter.
cAnimals vaccinated via intramuscular injection on Day 0 or Days 0 and 28 (see Table 1).
dBlood collected and sera isolated for TNA and ELISA on Days -6, 14, 28, 42 and 65 ± 4, when moribund euthanized or at terminal euthanasia (Day 84).
eRabbits challenged with 200 x ± 50 LD50 B. anthracis (Ames) spores. The published inhalation LD50 for NZW rabbits is 1.1 x 105 spores.
fBlood collected for CBC and differential.
gBlood collected and sera isolated for clinical chemistry parameters.
hBlood collected for quantitative bacteriology.
iBlood collected and sera isolated for electrochemiluminescence assay (ECL).
jMoribund euthanized or found dead rabbits received a limited gross necropsy.
kEuthanized or found dead rabbits received a gross necropsy and select tissues collected for bacteriology or histopathology.