Table 1. Maximum Severity of Systemic and Local Reactions by Study Group and Vaccination Number.
Subjects were examined for local and systemic reactions at 24 and 48 hr after each vaccination. Systemic and local reactogenicity events were collected for 8 days after each vaccination, or until resolution in subjects who experienced ongoing solicited events. Unsolicited adverse events were collected through 21 days after the subject's last immunization. All serious adverse events were collected throughout the study period. The proportion of subjects exhibiting the most severe local or systemic reaction that occurred after any vaccination and after each of the first two vaccinations is shown for each group. There were no adverse events of severe severity reported.
Vaccine Alone | Vaccine + 250 μg CPG 7909 | Vaccine + 500 μg CPG 7909 | Placebo | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Reactogenicity | Vacc Number |
N | None n (%) |
Mild n (%) |
Mod n (%) |
N | None n (%) |
Mild n (%) |
Mod n (%) |
N | None n (%) |
Mild n (%) |
Mod n (%) |
N | None n (%) |
Mild n (%) |
Mod n (%) |
Local | Any | 8 | 1 (13) | 4 (50) | 3 (38) | 8 | 1 (13) | 1 (13) | 6 (75) | 2 | 0 (0) | 1 (50) | 1 (50) | 2 | 1 (50) | 1 (50) | 0 (0) |
1 | 8 | 1 (13) | 5 (63) | 2 (25) | 8 | 2 (25) | 1 (13) | 5 (63) | 2 | 0 (0) | 1 (50) | 1 (50) | 2 | 2 (100) | 0 (0) | 0 (0) | |
2 | 8 | 3 (38) | 3 (38) | 2 (25) | 8 | 1 (13) | 4 (50) | 3 (38) | 2 | 1 (50) | 0 (0) | 1 (50) | 2 | 1 (50) | 1 (50) | 0 (0) | |
3 | 2 | 0 (0) | 2 (100) | 0 (0) | 2 | 2 (100) | 0 (0) | 0 (0) | 0 | NA | NA | NA | 2 | 2 (100) | 0 (0) | 0 (0) | |
Systemic | Any | 8 | 1 (13) | 5 (63) | 2 (25) | 8 | 0 (0) | 1 (13) | 7 (88) | 2 | 0 (0) | 2 (100) | 0 (0) | 2 | 1 (50) | 0 (0) | 1 (50) |
1 | 8 | 1 (13) | 6 (75) | 1 (13) | 8 | 0 (0) | 1 (13) | 7 (88) | 2 | 0 (0) | 2 (100) | 0 (0) | 2 | 2 (100) | 0 (0) | 0 (0) | |
2 | 8 | 4 (50) | 3 (38) | 1 (13) | 8 | 0 (0) | 6 (75) | 2 (25) | 2 | 2 (100) | 0 (0) | 0 (0) | 2 | 1 (50) | 0 (0) | 1 (50) | |
3 | 2 | 0 (0) | 2 (100) | 0 (0) | 2 | 0 (0) | 1 (50) | 1 (50) | 0 | NA | NA | NA | 2 | 2 (100) | 0 (0) | 0 (0) |