Table 2.
Study Injections and Baseline Demographic Characteristics in the Full Analysis Set
| Interval | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7 d | 14 d | 28 d | 56 d | ||||||||||
| Study Injections and Characteristics | Group 9 | Groups 1 and 10a | Group 5 | Group 6 | Group 7 | Placebo | Group 2 | Group 4 | Group 8 | Placebo | Group 3 | ||
| Study injections | |||||||||||||
| Dose 1 | MVA | Placebo | MVA | MVA | Ad26 | Ad26 | Placebo | MVA | Ad26 | hdAd26 | Placebo | MVA | Placebo |
| Dose 2 | Ad26 | Placebo | Ad26 | MVA | Ad26 | hdMVA | Placebo | Ad26 | MVA | hdMVA | Placebo | Ad26 | Placebo |
| Boosterb | None | None | Ad26 | Ad26 | MVA | Ad26 | None | Ad26 | Ad26 | hdAd26 | None | Ad26 | None |
| Participants, no. | 15 | 3 | 30 | 9 | 9 | 14 | 11 | 15 | 15 | 15 | 9 | 15 | 3 |
| Female sex, no. (%) | 6 (40) | 3 (100) | 6 (20) | 3 (33) | 6 (67) | 4 (29) | 7 (64) | 8 (53) | 6 (40) | 8 (53) | 2 (22) | 9 (60) | 2 (67) |
| Age, median (range), y | 28 (21–43) | 26 (25–28) | 26 (19–47) | 34 (20–48) | 39 (20–49) | 36.5 (23–50) | 25 (22–37) | 29 (20–50) | 35 (20–49) | 37 (24–50) | 27 (21–48) | 32 (21–50) | 21 (19–26) |
| Race, no. (%) | |||||||||||||
| White | 6 (40) | 1 (33) | 15 (50) | 7 (78) | 5 (56) | 9 (64) | 6 (55) | 8 (53) | 8 (53) | 9 (60) | 4 (44) | 7 (47) | 2 (67) |
| Black/AA | 7 (47) | 2 (67) | 12 (40) | 2 (22) | 4 (44) | 4 (29) | 5 (46) | 6 (40) | 6 (40) | 4 (27) | 4 (44) | 7 (47) | 1 (33) |
| Asian | 0 | 0 | 3 (10) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7) | 0 | 0 | 0 |
| Multiple | 2 (13) | 0 | 0 | 0 | 0 | 1 (7) | 0 | 1 (7) | 1 (7) | 0 | 0 | 1 (7) | 0 |
| Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7) | 0 | 0 | 0 |
| BMI, median (range)c | 24.3 (20.1–32.1) | 29.1 (27.5–32.4) | 27.1 (20.5–34.7) | 25.9 (22.3–34.6) | 29.9 (20.6–34.6) | 26.4 (20.6–34.5) | 24.9 (20.6–28.8) | 26.0 (22.5–33.0) | 24.3 (18.6–34.7) | 30.0 (22.4–33.7) | 27.5 (21.7–33.7) | 25.9 (19.7–33.8) | 25.3 (23.4–29.9) |
Abbreviations: Ad26, Ad26.ZEBOV; AA, African/American; BMI, body mass index; hdAd26, high-dose Ad26; hdMVA, high-dose MVA; MVA, MVA-BN-Filo.
aThis column combines groups 1 (MVA,Ad26 [dose 1, dose 2], [Ad26 booster]) and 10 (MVA,Ad26).
bBooster at day 360.
cBMI calculated as weight in kilograms divided by height in meters squared.