Table 3. Summary of post-immunization laboratory abnormalities by parameter and grade for subjects in both cohorts by true and mock groups over all five immunizations.

	Cohort 1				Cohort 2
	True Immunized N = 13		Mock Immunized N = 4		True Immunized N = 12		Mock Immunized N = 4
Lab test (units)	Grade 1 n (%)	Grade 2 n (%)	Grade 1 n (%)	Grade 2 n (%)	Grade 1 n (%)	Grade 2 n (%)	Grade 1 n (%)	Grade 2 n (%)
Any immunization
ALP (U/L)	1 (7.7)	0	1 (25)	0	0	0	0	0
ALT (U/L)	6 (46.2)	0	2 (50)	1 (25)	4 (33.3)	1 (8.3)	1 (25)	0
AST (U/L)	3 (23.1)	2 (15.4)	1 (25)	1 (25)	3 (25)	1 (8.3)	0	0
BUN (mg/dL)	4 (30.8)	2 (50)	2 (50)	0	1 (8.3)	0	2 (50)	0
Creatinine (mg/dL)	3 (23.1)	1 (7.7)	2 (50)	0	3 (25)	0	2 (50)	0
Eosinophils (cells/uL)	1 (7.7)	1 (7.7)	0	0	2 (16.7)	0	0	0
Hemoglobin (g/dL)	0	3 (23.1)	2 (50)	0	0	0	0	0
Lymphocytes (cells/uL)	3 (23.1)	3 (23.1)	1 (25)	3 (75)	2 (16.7)	0	0	0
Neutrophils (cells/uL)	3 (23.1)	2 (15.4)	1 (25)	1 (25)	0	0	0	0
Platelets (10x3/uL)	1 (7.7)	2 (15.4)	1 (25)	0	0	0	0	0
Total bilirubin (mg/dL)	2 (15.4)	0	0	0	1 (8.3)	0	0	0
WBC (10x3/uL)	5 (38.5)	1 (7.7)	1 (25)	1 (25)	3 (25)	0	0	0

Column header counts and denominators are the number of subjects who received at least one immunization.

Subjects with at least one abnormal lab within 7 days of any immunization are presented.

A subject is counted once per row.

No Grade 3 or 4 severity lab abnormalities were reported.