Table 1.
Cohort | Single-dose cohorts | Two-dose cohorts | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Age 21–55 | Age 56–80 | Age 21–55 | Age 56–80 | ||||||||||
Variable | Cohort A 1 µg | Cohort B 5 µg | Cohort C 10 µg | Cohort D1 7.5 µg | Pooled placebo cohorts A–D1 | Cohort D2 7.5 µg | Cohort D2 Placebo | Cohort E 5 µg | Cohort F 3 µg | Pooled placebo cohorts E–F | Cohort G 5 µg | Cohort H 3 µg | Pooled placebo cohorts G–H |
Number of participants | 5 | 10 | 5 | 5 | 10 | 5 | 2 | 12 | 12 | 8 | 12 | 12 | 8 |
Sex—n (%) | |||||||||||||
Male | 3 (60) | 6 (60) | 2 (40) | 4 (80) | 8 (20) | 5 (100) | 1 (50) | 8 (67) | 10 (83) | 5 (63) | 11 (92) | 8 (67) | 7 (88) |
Female | 2 (40) | 4 (40) | 3 (60) | 1 (20) | 2 (20) | 0 (0) | 1 (50) | 4 (33) | 2 (17) | 3 (38) | 1 (8) | 4 (33) | 1 (13) |
Race—n (%)b | |||||||||||||
Asian | 5 (100) | 10 (100) | 5 (100) | 4 (80) | 10 (100) | 5 (100) | 2 (100) | 11 (92) | 10 (83) | 7 (88) | 12 (100) | 12 (100) | 7 (88) |
White | 0 (0) | 0 (0) | 0 (0) | 1 (20) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 1 (13) | 0 (0) | 0 (0) | 1 (13) |
American Indian or Alaskan Native | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Other | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Hispanic Ethnic Group—n (%)b | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Age (years)c | |||||||||||||
Mean (SD) | 35 (9.17) | 39.5 (7.15) | 41.4 (12.48) | 40.4 (10.41) | 33.5 (8.72) | 64 (5.61) | 61.5 (6.36) | 34.5 (8.33) | 38 (9.34) | 39.1 (7.95) | 62.3 (4.63) | 61.7 (3.77) | 63.3 (5.70) |
Median [range] | 32.0 [28–50] | 40.0 [29–51] | 44.0 [24–55] | 47.0 [24–48] | 34.5 [21–46] | 64.0 [57–70] | 61.5 [57–66] | 35.5 [21–47] | 35.0 [22–51] | 37.0 [30–51] | 62.0 [56–70] | 61.5 [56–68] | 64.5 [56–71] |
N total number of subjects in each dose cohort, n number of subjects contributing to the summary, SD standard deviation.
aPercentages may not total 100 because of rounding.
bRace and ethnic group were reported by the participant.
cThe age of the participants was the age at the time of screening.