Table 1.
Volunteers given | Dose cohort (log10PFU) | No. of volunteers | No. of viremic | Number of volunteers with indicated sign:
|
|||||
---|---|---|---|---|---|---|---|---|---|
Systemic illnessa | Headache | Rash | Fever | Neutropeniac | Elevated ALTd | ||||
Initial LGT/DEN4 | 3.0 | 20 | 0 | 0 | 5 | 0 | 0 | 1 | 0 |
Initial placebo | 8 | 0 | 0 | 3 | 0 | 1b | 1 | 0 | |
Boost LGT/DEN4 | 3.0 | 19 | 1 | 0 | 3 | 0 | 0 | 0 | 0 |
Boost placebo | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Systemic illness is defined as ≥2 of the following symptoms lasting ≥2 days: headache, malaise, vomiting, arthralgia/malaise, nausea, or photophobia. There was no significant difference between vaccines and placebo recipients in the occurrence of any of the individual solicited symptoms used to define systemic illness. All solicited adverse events were mild or moderate in severity.
Fever occurred on study day 40; maximum temperature was 101.5°F.
Neutropenia is defined as an absolute neutrophil count of <1500 cells/mm3.
Elevated ALT level is defined as any value above the upper limit of normal (for males, >72U/L; for females, >52 U/L).