Table 1.

Design of the Sm-TSP-2/Al mouse potency assay in which groups of 10 BALB/c mice are vaccinated by the doses of adjuvant, Clinical Drug Substance, and Clinical Drug Product below to estimate the median Effective Dose or ED₅₀ and relative potency at release and pre-defined post-release timepoints.

Group	Formulation	Dose (μg)a		Volume (mL)
		Sm-TSP-2	Alhydrogel®
1	Adjuvant	–	400	0.500
2	Clinical Drug Substance	50	–	0.023
3	Clinical Drug Product	50	400	0.500
4	Clinical Drug Product	28.57	228.56	0.286
5	Clinical Drug Product	16.33	130.64	0.163
6	Clinical Drug Product	9.33	74.64	0.093
7	Clinical Drug Product	5.33	42.64	0.053
8	Clinical Drug Product	3.05	24.4	0.031
9	Clinical Drug Product	1.74	13.92	0.017
10	Clinical Drug Product	0.99	7.92	0.010
11	Immunizability Controlb	9.33	74.64	0.093

^aThe symbol “--” means not applicable.

^bThe term “immunizability control” refers to vaccination using Formulated Reference Standard (Reference Standard drug substance formulated with Alhydrogel®) and is used to determine variation in the immune response from different “lots” of animals sent to the vivarium. No comparisons are made to the antibody values generated by this group with the clinical drug product.