| Characteristic . | Placebo N = 45 . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . | ||
| Mean age, year (range) | 35.5 (19–50) | 36.1 (21–50) | 36.2 (23–49) | 37.0 (19–50) | 35.9 (23–50) | 35.1 (21–49) | 37.6 (24–50) |
| Female sex, n (%) | 32 (71.1) | 36 (81.8) | 31 (68.9) | 32 (72.7) | 30 (68.2) | 26 (59.1) | 29 (65.9) |
| Race, n (%) | |||||||
| White | 26 (57.8) | 22 (50.0) | 26 (57.8) | 26 (59.1) | 31 (70.5) | 30 (68.2) | 28 (63.6) |
| African American | 16 (35.6) | 19 (43.2) | 16 (35.6) | 15 (34.1) | 12 (27.3) | 13 (29.5) | 13 (29.5) |
| Other | 3 (6.7) | 3 (6.8) | 3 (6.7) | 3 (6.8) | 1 (2.3) | 1 (2.3) | 3 (6.8) |
| Mean time from initial diagnosis of HSV-2 to randomization, years (range) | 8.0 (1–31) | 10.7 (1–30) | 9.0 (1–30) | 10.7 (1–33) | 11.2 (2–31) | 9.1 (1–30) | 11.7 (2–33) |
| Mean number of episodes in last 12-month period without suppression (range)a | 5.2 (3–9) | 5.1 (3–9) | 5.3 (39) | 5.4 (3–9) | 4.6 (3–8) | 5.5 (3–9) | 4.9 (3–9) |
| Ever on suppressive therapy before study entry, n (%) | 25 (55.6) | 28 (63.6) | 29 (64.4) | 28 (63.6) | 32 (72.7) | 29 (65.9) | 26 (59.1) |
| Current treatment with antiviral suppression therapy, n (%)b | 8 (17.8) | 10 (22.7) | 5 (11.1) | 10 (22.7) | 10 (22.7) | 12 (27.3) | 9 (20.5) |
| History of oral lesions or HSV-1 diagnoses, n (%) | 11 (24.4) | 8 (18.2) | 11 (24.4) | 13 (29.5) | 11 (25.0) | 8 (18.2) | 12 (27.3) |
| Characteristic . | Placebo N = 45 . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . | ||
| Mean age, year (range) | 35.5 (19–50) | 36.1 (21–50) | 36.2 (23–49) | 37.0 (19–50) | 35.9 (23–50) | 35.1 (21–49) | 37.6 (24–50) |
| Female sex, n (%) | 32 (71.1) | 36 (81.8) | 31 (68.9) | 32 (72.7) | 30 (68.2) | 26 (59.1) | 29 (65.9) |
| Race, n (%) | |||||||
| White | 26 (57.8) | 22 (50.0) | 26 (57.8) | 26 (59.1) | 31 (70.5) | 30 (68.2) | 28 (63.6) |
| African American | 16 (35.6) | 19 (43.2) | 16 (35.6) | 15 (34.1) | 12 (27.3) | 13 (29.5) | 13 (29.5) |
| Other | 3 (6.7) | 3 (6.8) | 3 (6.7) | 3 (6.8) | 1 (2.3) | 1 (2.3) | 3 (6.8) |
| Mean time from initial diagnosis of HSV-2 to randomization, years (range) | 8.0 (1–31) | 10.7 (1–30) | 9.0 (1–30) | 10.7 (1–33) | 11.2 (2–31) | 9.1 (1–30) | 11.7 (2–33) |
| Mean number of episodes in last 12-month period without suppression (range)a | 5.2 (3–9) | 5.1 (3–9) | 5.3 (39) | 5.4 (3–9) | 4.6 (3–8) | 5.5 (3–9) | 4.9 (3–9) |
| Ever on suppressive therapy before study entry, n (%) | 25 (55.6) | 28 (63.6) | 29 (64.4) | 28 (63.6) | 32 (72.7) | 29 (65.9) | 26 (59.1) |
| Current treatment with antiviral suppression therapy, n (%)b | 8 (17.8) | 10 (22.7) | 5 (11.1) | 10 (22.7) | 10 (22.7) | 12 (27.3) | 9 (20.5) |
| History of oral lesions or HSV-1 diagnoses, n (%) | 11 (24.4) | 8 (18.2) | 11 (24.4) | 13 (29.5) | 11 (25.0) | 8 (18.2) | 12 (27.3) |
Abbreviations: HSV-1, herpes simplex virus type 1.
aDuring year before initiation of suppressive therapy for those on suppressive therapy.
bTreatment with antiviral suppression therapy at the time of screening (all subjects discontinued antiviral therapy at least 7 days before the baseline swab collection period).
| Characteristic . | Placebo N = 45 . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . | ||
| Mean age, year (range) | 35.5 (19–50) | 36.1 (21–50) | 36.2 (23–49) | 37.0 (19–50) | 35.9 (23–50) | 35.1 (21–49) | 37.6 (24–50) |
| Female sex, n (%) | 32 (71.1) | 36 (81.8) | 31 (68.9) | 32 (72.7) | 30 (68.2) | 26 (59.1) | 29 (65.9) |
| Race, n (%) | |||||||
| White | 26 (57.8) | 22 (50.0) | 26 (57.8) | 26 (59.1) | 31 (70.5) | 30 (68.2) | 28 (63.6) |
| African American | 16 (35.6) | 19 (43.2) | 16 (35.6) | 15 (34.1) | 12 (27.3) | 13 (29.5) | 13 (29.5) |
| Other | 3 (6.7) | 3 (6.8) | 3 (6.7) | 3 (6.8) | 1 (2.3) | 1 (2.3) | 3 (6.8) |
| Mean time from initial diagnosis of HSV-2 to randomization, years (range) | 8.0 (1–31) | 10.7 (1–30) | 9.0 (1–30) | 10.7 (1–33) | 11.2 (2–31) | 9.1 (1–30) | 11.7 (2–33) |
| Mean number of episodes in last 12-month period without suppression (range)a | 5.2 (3–9) | 5.1 (3–9) | 5.3 (39) | 5.4 (3–9) | 4.6 (3–8) | 5.5 (3–9) | 4.9 (3–9) |
| Ever on suppressive therapy before study entry, n (%) | 25 (55.6) | 28 (63.6) | 29 (64.4) | 28 (63.6) | 32 (72.7) | 29 (65.9) | 26 (59.1) |
| Current treatment with antiviral suppression therapy, n (%)b | 8 (17.8) | 10 (22.7) | 5 (11.1) | 10 (22.7) | 10 (22.7) | 12 (27.3) | 9 (20.5) |
| History of oral lesions or HSV-1 diagnoses, n (%) | 11 (24.4) | 8 (18.2) | 11 (24.4) | 13 (29.5) | 11 (25.0) | 8 (18.2) | 12 (27.3) |
| Characteristic . | Placebo N = 45 . | GEN-003 (µg of antigens/µg of adjuvant) . | |||||
|---|---|---|---|---|---|---|---|
| 30/25 N = 44 . | 30/50 N = 45 . | 30/75 N = 44 . | 60/25 N = 44 . | 60/50 N = 44 . | 60/75 N = 44 . | ||
| Mean age, year (range) | 35.5 (19–50) | 36.1 (21–50) | 36.2 (23–49) | 37.0 (19–50) | 35.9 (23–50) | 35.1 (21–49) | 37.6 (24–50) |
| Female sex, n (%) | 32 (71.1) | 36 (81.8) | 31 (68.9) | 32 (72.7) | 30 (68.2) | 26 (59.1) | 29 (65.9) |
| Race, n (%) | |||||||
| White | 26 (57.8) | 22 (50.0) | 26 (57.8) | 26 (59.1) | 31 (70.5) | 30 (68.2) | 28 (63.6) |
| African American | 16 (35.6) | 19 (43.2) | 16 (35.6) | 15 (34.1) | 12 (27.3) | 13 (29.5) | 13 (29.5) |
| Other | 3 (6.7) | 3 (6.8) | 3 (6.7) | 3 (6.8) | 1 (2.3) | 1 (2.3) | 3 (6.8) |
| Mean time from initial diagnosis of HSV-2 to randomization, years (range) | 8.0 (1–31) | 10.7 (1–30) | 9.0 (1–30) | 10.7 (1–33) | 11.2 (2–31) | 9.1 (1–30) | 11.7 (2–33) |
| Mean number of episodes in last 12-month period without suppression (range)a | 5.2 (3–9) | 5.1 (3–9) | 5.3 (39) | 5.4 (3–9) | 4.6 (3–8) | 5.5 (3–9) | 4.9 (3–9) |
| Ever on suppressive therapy before study entry, n (%) | 25 (55.6) | 28 (63.6) | 29 (64.4) | 28 (63.6) | 32 (72.7) | 29 (65.9) | 26 (59.1) |
| Current treatment with antiviral suppression therapy, n (%)b | 8 (17.8) | 10 (22.7) | 5 (11.1) | 10 (22.7) | 10 (22.7) | 12 (27.3) | 9 (20.5) |
| History of oral lesions or HSV-1 diagnoses, n (%) | 11 (24.4) | 8 (18.2) | 11 (24.4) | 13 (29.5) | 11 (25.0) | 8 (18.2) | 12 (27.3) |
Abbreviations: HSV-1, herpes simplex virus type 1.
aDuring year before initiation of suppressive therapy for those on suppressive therapy.
bTreatment with antiviral suppression therapy at the time of screening (all subjects discontinued antiviral therapy at least 7 days before the baseline swab collection period).
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