Table 4.

Design of postexposure efficacy study in rabbits (time-based intervention)

Treatment group	Product	No. of animals/groupa	IgG (mg/kg)		Time of treatment postchallenge (h)	Inhaled dose (LD50)		Blood collection time pointsb
			Anti-PA	Total		Target	Actual [mean ± SD (range)]	PA (by ELISA) and bacteremia	Anti-PA and TNA levels
1	AIGIV	18	14.2	364	12	200	194 ± 40 (86–256)	Prechallenge day −7	Prechallenge day −7
2	AIGIV	18	21.3	546	12	200	220 ± 43 (140–389)	Postchallenge, PTI	Postchallenge, PTI
3	AIGIV	18	14.2	364	24	200	222 ± 58 (116–397)	Postinfusion days 2, 6, 10, and 28	Postinfusion hours 1, 4, 12, 24, 48, 72, and 96
4	AIGIV	18	21.3	546	24	200	194 ± 35 (120–253)		Postinfusion days 6, 10, 21 and 28
5	Gamunex	12	0	546	12	200	182 ± 51 (124–281)

^aEqual number of males and females were used.

^bPTI, prior to infusion.