Table 1.

Summary of three clinical studies of smallpox vaccine LC16m8.

Study	Saito [6]		Nishiyama [7]a		Kennedy [8]
Country	Japan		Japan		USA
Study design	Clinical study, open-label		Post-marketing surveillance		Clinical trial phase I/II, randomized, double-blind
Race	Asian (100%)		Asian (100%)		Native American (1%), Asian (6%), African American (2%), Pacific Islander (1%), Caucasian (88%), Multiracial (2%)
Vaccine	LC16m8		LC16m8		LC16m8	Dryvax
Vaccination status	Naive	Vaccinated	Naive	Vaccinated	Naive	Naive
Number of participants	1529	1692	196	71	125	28
Number of punctures	5	10	5	10	15	15
Major cutaneous reaction (“take”) (%)	94.4	86.6	94.4	81.7	100	86b
Serious adverse events	No	No	No	No	No	No
Weak or mild adverse events (%)c	22.4	6.6	27.0	5.6	82	68
Swollen axillary lymph nodes (%)	15.5	3.5	25.5	2.8	37	46
Swollen cervical lymph nodes (%)	0.4	0.2	–d	–	–	–
Fever (%)	2.6	1.4	1.0e	2.8e	–	–

Three studies are summarized based on data from references [6], [7], [8].

^aThe vaccination history of one participant in the Nishiyama study was unknown.

^bSee text.

^cRate for local reactogenicity in the Kennedy 2011 study.

^dNot described.

^eFever was recorded for two participants for both Naive and Vaccinated groups.