Table 2.
Subjects with alert laboratory values
| Subject no. | Vaccine group | Alert value | Time point for alert value | Outcome |
|---|---|---|---|---|
| 3 | Cohort A | ANC = 787 cells/mm3 | Day 0 | PLT (day 0) = 223,000 cells/mm3, repeat ANC on day 10 = 3,310 cells/mm3, DENV/JE IgM (days 0 and 10) was negative |
| 12 | Cohort B | AST = 149 U/L, ALT = 181 U/L, ALT = 232 U/L, AST = 237 U/L, ALT = 289 U/L | Day 0, Day 10 post-dose 1, Day 10 post-dose 2 (DEN-4 viremia) | AST = 46 U/L, ALT = 35 U/L at end of study; see text for more details |
| 13 | Cohort B | ANC = 934 cells/mm3, PLT = 37,000 cells/mm3 | Day 0 | DENV/JE IgM ELISA (day 0) was negative, ANC (day 2) = 1,640 cells/mm3, PLT (day 2) = 304,000 cells/mm3 |
| 34 | Cohort C | ANC = 468 cells/mm3, PLT = 46,000 cells/mm3, PLT = 530,000 cells/mm3 | Day 30 post-dose 1, Day 30 post-dose 1, Day 0 pre-dose 2 | DENV PCR (day 30) was negative, ANC (day 32) = 2,740 cells/mm3, PLT (day 32) = 389,000 cells/mm3 |
| 35 | Cohort C | PLT = 17,000 cells/mm3 | Day 180 post-dose 1 (pre-dose 2) | PLT (day 183) = 318,000 cells/mm3, DENV PCR (day 180 post-dose 1) was negative, DEN (IgM) ELISA (day 183) was negative |
| 46 | Cohort C | AST = 83 U/L, AST = 153 U/L | Day 0 pre-dose 1, Day 0 pre-dose 2 | AST decreased but remained above the normal range with ALT normal until last visit, when it was twice normal |
| 19 | Control | PLT = 84,300 cells/mm3 | Day 0 | Normal at all other time points |
| 27 | Control | PLT = 75,700 cells/mm3 | Day 10 post-dose 1 | Normal at all other time points |
Alert value for ANC was < 1,000 cells/mm3. Alert value for PLT count was < 100,000 cells/mm3. Alert value for AST was > 2.5 times the upper limit of normal (i.e., > 142 U/L). Alert value for ALT was > 2.5 times the upper limit of normal (i.e., > 135 U/L).