Table 1.
Participant Characteristics
| Characteristic | Biojector active | Electroporation Active | Biojector placebo | Electroporation placebo | P value | Total |
|---|---|---|---|---|---|---|
| Planned enrollment | 38 | 38 | 8 | 8 | 92 | |
| Actual enrollmenta | 43 | 41 | 8 | 8 | 100 | |
| Sex | ||||||
| Male | 31 (72.1) | 33 (80.5) | 5 (62.5) | 7 (87.5) | .56 | 76 |
| Female | 12 (27.9) | 8 (19.5) | 3 (37.5) | 1 (12.5) | 24 | |
| Ethnicity/race | ||||||
| White, non-Hispanic | 2 (4.7) | 1 (2.4) | 0 (0) | 0 (0) | NA | 3 |
| African or African-American, non-Hispanic | 41 (95.4) | 39 (95.1) | 8 (100) | 8 (100) | 96 | |
| Hispanic | 0 (0) | 0 (0) | 0 (0) | 0 | 0 | |
| Other | 0 (0) | 1 (2.4) | 0 (0) | 0 (0) | 1 | |
| Age, y | 26 (18–47) | 29 (18–48) | 22 (18–43) | 27 (20–39) | .40 | 27 (18–48) |
| Body mass index, kg/m2 | 22.1 (18.3–30.1) | 21.9 (18.0–32.7) | 23.0 (19.8–26.6) | 20.7 (18.3–24.7) | .50 | 21.9 (18.0–32.7) |
| Vaccinations received | ||||||
| 1st (PV-G/placebo; month 0) | 43 (100) | 41 (100) | 8 (100) | 8 (100) | 100 | |
| 2nd (PV-G/placebo; month 1) | 40 (93.0) | 41 (100) | 8 (100) | 8 (100) | 97 | |
| 3rd (MVA-CMDR/placebo; month 3) | 38 (88.4) | 36 (87.8) | 7 (87.5) | 8 (100) | 89 | |
| 4th (MVA-CMDR/placebo; month 6) | 37 (86.0) | 36 (87.8) | 7 (87.5) | 8 (100) | 88 | |
| All | 37 (86.0) | 36 (87.8) | 7 (87.5) | 8 (100) | 88 |
Data are n. (%) of participants or median (range). Fisher’s exact test used for comparisons by sex; Wilcoxon rank sum test used for age and body mass comparisons.
Abbreviation: NA, not applicable.
aReplacements were allowed until enrollment was closed at each site.