Table 2. Open in new tab Viral Shedding...

Time point	Placebo N = 45	GEN-003 (µg of antigens/µg of adjuvant)
Viral Shedding Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)^a	555/2396 (23.2)	325/2387 (13.6)	431/2465 (17.5)	349/2406 (14.5)	465/2386 (19.5)	648/2387 (27.1)	452/2387 (18.9)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^a	535/2411 (22.2)	259/2297 (11.3)	230/2136 (10.8)	218/2337 (9.3)	247/2254 (11.0)	362/2263 (16.0)	186/2180 (8.5)
	Rate ratio (95% CI)^b	0.98 (0.76–1.26)	0.82 (0.49–1.36)	0.64 (0.45–0.92)	0.63 (0.37–1.10)	0.56 (0.36–0.88)	0.58 (0.38–0.89)	0.45 (0.16–0.79)
	Within-group P value^c	.88	.44	.02	.11	.01	.01	.01
Month 6	N	NA	38	38	41	40	38	39
	Proportion (%)^a	NA	241/2039 (11.8)	179/2067 (8.7)	308/2246 (13.7)	251/2124 (11.8)	297/2045 (14.5)	165/2091 (7.9)
	Rate ratio (95% CI)^b	NA	0.92 (0.66–1.29)	0.54 (0.29–1.01)	0.94 (0.61–1.45)	0.61 (0.43–0.87)	0.55 (0.40–0.77)	0.41 (0.26–0.63)
	Within-group P value^c	NA	.62	.05	.78	.01	.0004	<.0001
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^a	NA	154/1944 (7.9)	217/1952 (11.1)	112/2145 (5.2)	303/2056 (14.7)	186/2021 (9.2)	176/2041 (8.6)
	Rate ratio (95% CI)^b	NA	0.64 (0.35–1.17)	0.69 (0.37–1.31)	0.34 (0.19–0.61)	0.79 (0.50–1.25)	0.38 (0.25–0.57)	0.43 (0.23–0.82)
	Within-group P value^c	NA	.15	.25	.0003	.32	<.0001	.01
Viral Lesion Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)	207/1271 (16.3)	117/1245 (9.4)	115/1276 (9.0)	178/1234 (14.4)	187/1236 (15.1)	156/1236 (12.6)	155/1233 (12.6)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^d	77/1239 (6.2)	59/1191 (5.0)	71/1143 (6.2)	89/1208 (7.4)	66/1206 (5.5)	46/1182 (3.9)	58/1151 (5.0)
	Rate ratio (95% CI)^e	0.38 (0.23–0.63)	0.55 (0.34–0.91)	0.67 (0.37–1.23)	0.50 (0.26–0.95)	0.36 (0.17–0.73)	0.30 (0.16–0.59)	0.41 (0.20–0.87)
	Within-group P value^c	.0002	.02	.19	.03	.005	.0005	.02
Month 6	N	NA	39	38	41	40	38	39
	Proportion (%)^d	NA	115/1094 (10.5)	41/1053 (3.9)	86/1148 (7.5)	54/1135 (4.8)	67/1059 (6.3)	78/1085 (7.2)
	Rate ratio (95% CI)^e	NA	1.22 (0.82–1.82)	0.43 (0.19–0.99)	0.51 (0.28–0.93)	0.32 (0.18–0.58)	0.51 (0.30–0.85)	0.57 (0.34–0.95)
	Within-group P value^c	NA	.32	.05	.03	.0001	.01	.03
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^d	NA	79/1000 (7.9)	40/1002 (4.0)	76/1089 (7.0)	66/1068 (6.2)	46/1043 (4.4)	71/1060 (6.7)
	Rate ratio (95% CI)^e	NA	0.95 (0.54–1.66)	0.42 (0.18–0.96)	0.46 (0.23–0.92)	0.42 (0.21–0.83)	0.35 (0.18–0.71)	0.53 (0.31–0.89)
	Within-group P value^c	NA	.85	.04	.03	.01	.003	.02

Time point

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

Viral Shedding Rate

Baseline

Proportion (%)^a

555/2396 (23.2)

325/2387 (13.6)

431/2465 (17.5)

349/2406 (14.5)

465/2386 (19.5)

648/2387 (27.1)

452/2387 (18.9)

Immediate postvaccination period

Proportion (%)^a

535/2411 (22.2)

259/2297 (11.3)

230/2136 (10.8)

218/2337 (9.3)

247/2254 (11.0)

362/2263 (16.0)

186/2180 (8.5)

Rate ratio (95% CI)^b

0.98
(0.76–1.26)

0.82
(0.49–1.36)

0.64
(0.45–0.92)

0.63
(0.37–1.10)

0.56
(0.36–0.88)

0.58
(0.38–0.89)

0.45
(0.16–0.79)

Within-group P value^c

.88

.44

.02

.11

.01

Month 6

Proportion (%)^a

241/2039 (11.8)

179/2067 (8.7)

308/2246 (13.7)

251/2124 (11.8)

297/2045 (14.5)

165/2091 (7.9)

Rate ratio (95% CI)^b

0.92
(0.66–1.29)

0.54
(0.29–1.01)

0.94
(0.61–1.45)

0.61
(0.43–0.87)

0.55
(0.40–0.77)

0.41
(0.26–0.63)

Within-group P value^c

.62

.05

.78

.01

.0004

<.0001

Month 12

Proportion (%)^a

154/1944 (7.9)

217/1952 (11.1)

112/2145 (5.2)

303/2056 (14.7)

186/2021 (9.2)

176/2041 (8.6)

Rate ratio (95% CI)^b

0.64
(0.35–1.17)

0.69
(0.37–1.31)

0.34
(0.19–0.61)

0.79
(0.50–1.25)

0.38
(0.25–0.57)

0.43
(0.23–0.82)

Within-group P value^c

.15

.25

.0003

.32

<.0001

.01

Viral Lesion Rate

Baseline

Proportion (%)

207/1271 (16.3)

117/1245 (9.4)

115/1276 (9.0)

178/1234 (14.4)

187/1236 (15.1)

156/1236 (12.6)

155/1233 (12.6)

Immediate postvaccination period

Proportion (%)^d

77/1239 (6.2)

59/1191 (5.0)

71/1143 (6.2)

89/1208 (7.4)

66/1206 (5.5)

46/1182 (3.9)

58/1151 (5.0)

Rate ratio (95% CI)^e

0.38
(0.23–0.63)

0.55
(0.34–0.91)

0.67
(0.37–1.23)

0.50
(0.26–0.95)

0.36
(0.17–0.73)

0.30
(0.16–0.59)

0.41
(0.20–0.87)

Within-group P value^c

.0002

.02

.19

.03

.005

.0005

.02

Month 6

Proportion (%)^d

115/1094 (10.5)

41/1053 (3.9)

86/1148 (7.5)

54/1135 (4.8)

67/1059 (6.3)

78/1085 (7.2)

Rate ratio (95% CI)^e

1.22
(0.82–1.82)

0.43
(0.19–0.99)

0.51
(0.28–0.93)

0.32
(0.18–0.58)

0.51
(0.30–0.85)

0.57
(0.34–0.95)

Within-group P value^c

.32

.05

.03

.0001

.01

.03

Month 12

Proportion (%)^d

79/1000 (7.9)

40/1002 (4.0)

76/1089 (7.0)

66/1068 (6.2)

46/1043 (4.4)

71/1060 (6.7)

Rate ratio (95% CI)^e

0.95
(0.54–1.66)

0.42
(0.18–0.96)

0.46
(0.23–0.92)

0.42
(0.21–0.83)

0.35
(0.18–0.71)

0.53
(0.31–0.89)

Within-group P value^c

.85

.04

.03

.01

.003

.02

Time point	Placebo N = 45	GEN-003 (µg of antigens/µg of adjuvant)
Viral Shedding Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)^a	555/2396 (23.2)	325/2387 (13.6)	431/2465 (17.5)	349/2406 (14.5)	465/2386 (19.5)	648/2387 (27.1)	452/2387 (18.9)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^a	535/2411 (22.2)	259/2297 (11.3)	230/2136 (10.8)	218/2337 (9.3)	247/2254 (11.0)	362/2263 (16.0)	186/2180 (8.5)
	Rate ratio (95% CI)^b	0.98 (0.76–1.26)	0.82 (0.49–1.36)	0.64 (0.45–0.92)	0.63 (0.37–1.10)	0.56 (0.36–0.88)	0.58 (0.38–0.89)	0.45 (0.16–0.79)
	Within-group P value^c	.88	.44	.02	.11	.01	.01	.01
Month 6	N	NA	38	38	41	40	38	39
	Proportion (%)^a	NA	241/2039 (11.8)	179/2067 (8.7)	308/2246 (13.7)	251/2124 (11.8)	297/2045 (14.5)	165/2091 (7.9)
	Rate ratio (95% CI)^b	NA	0.92 (0.66–1.29)	0.54 (0.29–1.01)	0.94 (0.61–1.45)	0.61 (0.43–0.87)	0.55 (0.40–0.77)	0.41 (0.26–0.63)
	Within-group P value^c	NA	.62	.05	.78	.01	.0004	<.0001
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^a	NA	154/1944 (7.9)	217/1952 (11.1)	112/2145 (5.2)	303/2056 (14.7)	186/2021 (9.2)	176/2041 (8.6)
	Rate ratio (95% CI)^b	NA	0.64 (0.35–1.17)	0.69 (0.37–1.31)	0.34 (0.19–0.61)	0.79 (0.50–1.25)	0.38 (0.25–0.57)	0.43 (0.23–0.82)
	Within-group P value^c	NA	.15	.25	.0003	.32	<.0001	.01
Viral Lesion Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)	207/1271 (16.3)	117/1245 (9.4)	115/1276 (9.0)	178/1234 (14.4)	187/1236 (15.1)	156/1236 (12.6)	155/1233 (12.6)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^d	77/1239 (6.2)	59/1191 (5.0)	71/1143 (6.2)	89/1208 (7.4)	66/1206 (5.5)	46/1182 (3.9)	58/1151 (5.0)
	Rate ratio (95% CI)^e	0.38 (0.23–0.63)	0.55 (0.34–0.91)	0.67 (0.37–1.23)	0.50 (0.26–0.95)	0.36 (0.17–0.73)	0.30 (0.16–0.59)	0.41 (0.20–0.87)
	Within-group P value^c	.0002	.02	.19	.03	.005	.0005	.02
Month 6	N	NA	39	38	41	40	38	39
	Proportion (%)^d	NA	115/1094 (10.5)	41/1053 (3.9)	86/1148 (7.5)	54/1135 (4.8)	67/1059 (6.3)	78/1085 (7.2)
	Rate ratio (95% CI)^e	NA	1.22 (0.82–1.82)	0.43 (0.19–0.99)	0.51 (0.28–0.93)	0.32 (0.18–0.58)	0.51 (0.30–0.85)	0.57 (0.34–0.95)
	Within-group P value^c	NA	.32	.05	.03	.0001	.01	.03
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^d	NA	79/1000 (7.9)	40/1002 (4.0)	76/1089 (7.0)	66/1068 (6.2)	46/1043 (4.4)	71/1060 (6.7)
	Rate ratio (95% CI)^e	NA	0.95 (0.54–1.66)	0.42 (0.18–0.96)	0.46 (0.23–0.92)	0.42 (0.21–0.83)	0.35 (0.18–0.71)	0.53 (0.31–0.89)
	Within-group P value^c	NA	.85	.04	.03	.01	.003	.02

Table 2.

Open in new tab

Viral Shedding and Lesion Rates

Time point		Placebo N = 45	GEN-003 (µg of antigens/µg of adjuvant)
Time point		Placebo N = 45	30/25 N = 44	30/50 N = 45	30/75 N = 44	60/25 N = 44	60/50 N = 44	60/75 N = 44
Viral Shedding Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)^a	555/2396 (23.2)	325/2387 (13.6)	431/2465 (17.5)	349/2406 (14.5)	465/2386 (19.5)	648/2387 (27.1)	452/2387 (18.9)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^a	535/2411 (22.2)	259/2297 (11.3)	230/2136 (10.8)	218/2337 (9.3)	247/2254 (11.0)	362/2263 (16.0)	186/2180 (8.5)
	Rate ratio (95% CI)^b	0.98 (0.76–1.26)	0.82 (0.49–1.36)	0.64 (0.45–0.92)	0.63 (0.37–1.10)	0.56 (0.36–0.88)	0.58 (0.38–0.89)	0.45 (0.16–0.79)
	Within-group P value^c	.88	.44	.02	.11	.01	.01	.01
Month 6	N	NA	38	38	41	40	38	39
	Proportion (%)^a	NA	241/2039 (11.8)	179/2067 (8.7)	308/2246 (13.7)	251/2124 (11.8)	297/2045 (14.5)	165/2091 (7.9)
	Rate ratio (95% CI)^b	NA	0.92 (0.66–1.29)	0.54 (0.29–1.01)	0.94 (0.61–1.45)	0.61 (0.43–0.87)	0.55 (0.40–0.77)	0.41 (0.26–0.63)
	Within-group P value^c	NA	.62	.05	.78	.01	.0004	<.0001
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^a	NA	154/1944 (7.9)	217/1952 (11.1)	112/2145 (5.2)	303/2056 (14.7)	186/2021 (9.2)	176/2041 (8.6)
	Rate ratio (95% CI)^b	NA	0.64 (0.35–1.17)	0.69 (0.37–1.31)	0.34 (0.19–0.61)	0.79 (0.50–1.25)	0.38 (0.25–0.57)	0.43 (0.23–0.82)
	Within-group P value^c	NA	.15	.25	.0003	.32	<.0001	.01
Viral Lesion Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)	207/1271 (16.3)	117/1245 (9.4)	115/1276 (9.0)	178/1234 (14.4)	187/1236 (15.1)	156/1236 (12.6)	155/1233 (12.6)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^d	77/1239 (6.2)	59/1191 (5.0)	71/1143 (6.2)	89/1208 (7.4)	66/1206 (5.5)	46/1182 (3.9)	58/1151 (5.0)
	Rate ratio (95% CI)^e	0.38 (0.23–0.63)	0.55 (0.34–0.91)	0.67 (0.37–1.23)	0.50 (0.26–0.95)	0.36 (0.17–0.73)	0.30 (0.16–0.59)	0.41 (0.20–0.87)
	Within-group P value^c	.0002	.02	.19	.03	.005	.0005	.02
Month 6	N	NA	39	38	41	40	38	39
	Proportion (%)^d	NA	115/1094 (10.5)	41/1053 (3.9)	86/1148 (7.5)	54/1135 (4.8)	67/1059 (6.3)	78/1085 (7.2)
	Rate ratio (95% CI)^e	NA	1.22 (0.82–1.82)	0.43 (0.19–0.99)	0.51 (0.28–0.93)	0.32 (0.18–0.58)	0.51 (0.30–0.85)	0.57 (0.34–0.95)
	Within-group P value^c	NA	.32	.05	.03	.0001	.01	.03
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^d	NA	79/1000 (7.9)	40/1002 (4.0)	76/1089 (7.0)	66/1068 (6.2)	46/1043 (4.4)	71/1060 (6.7)
	Rate ratio (95% CI)^e	NA	0.95 (0.54–1.66)	0.42 (0.18–0.96)	0.46 (0.23–0.92)	0.42 (0.21–0.83)	0.35 (0.18–0.71)	0.53 (0.31–0.89)
	Within-group P value^c	NA	.85	.04	.03	.01	.003	.02

Time point		Placebo N = 45	GEN-003 (µg of antigens/µg of adjuvant)
Time point		Placebo N = 45	30/25 N = 44	30/50 N = 45	30/75 N = 44	60/25 N = 44	60/50 N = 44	60/75 N = 44
Viral Shedding Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)^a	555/2396 (23.2)	325/2387 (13.6)	431/2465 (17.5)	349/2406 (14.5)	465/2386 (19.5)	648/2387 (27.1)	452/2387 (18.9)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^a	535/2411 (22.2)	259/2297 (11.3)	230/2136 (10.8)	218/2337 (9.3)	247/2254 (11.0)	362/2263 (16.0)	186/2180 (8.5)
	Rate ratio (95% CI)^b	0.98 (0.76–1.26)	0.82 (0.49–1.36)	0.64 (0.45–0.92)	0.63 (0.37–1.10)	0.56 (0.36–0.88)	0.58 (0.38–0.89)	0.45 (0.16–0.79)
	Within-group P value^c	.88	.44	.02	.11	.01	.01	.01
Month 6	N	NA	38	38	41	40	38	39
	Proportion (%)^a	NA	241/2039 (11.8)	179/2067 (8.7)	308/2246 (13.7)	251/2124 (11.8)	297/2045 (14.5)	165/2091 (7.9)
	Rate ratio (95% CI)^b	NA	0.92 (0.66–1.29)	0.54 (0.29–1.01)	0.94 (0.61–1.45)	0.61 (0.43–0.87)	0.55 (0.40–0.77)	0.41 (0.26–0.63)
	Within-group P value^c	NA	.62	.05	.78	.01	.0004	<.0001
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^a	NA	154/1944 (7.9)	217/1952 (11.1)	112/2145 (5.2)	303/2056 (14.7)	186/2021 (9.2)	176/2041 (8.6)
	Rate ratio (95% CI)^b	NA	0.64 (0.35–1.17)	0.69 (0.37–1.31)	0.34 (0.19–0.61)	0.79 (0.50–1.25)	0.38 (0.25–0.57)	0.43 (0.23–0.82)
	Within-group P value^c	NA	.15	.25	.0003	.32	<.0001	.01
Viral Lesion Rate
Baseline	N	44	44	45	44	44	44	44
	Proportion (%)	207/1271 (16.3)	117/1245 (9.4)	115/1276 (9.0)	178/1234 (14.4)	187/1236 (15.1)	156/1236 (12.6)	155/1233 (12.6)
Immediate postvaccination period	N	45	43	40	43	44	42	41
	Proportion (%)^d	77/1239 (6.2)	59/1191 (5.0)	71/1143 (6.2)	89/1208 (7.4)	66/1206 (5.5)	46/1182 (3.9)	58/1151 (5.0)
	Rate ratio (95% CI)^e	0.38 (0.23–0.63)	0.55 (0.34–0.91)	0.67 (0.37–1.23)	0.50 (0.26–0.95)	0.36 (0.17–0.73)	0.30 (0.16–0.59)	0.41 (0.20–0.87)
	Within-group P value^c	.0002	.02	.19	.03	.005	.0005	.02
Month 6	N	NA	39	38	41	40	38	39
	Proportion (%)^d	NA	115/1094 (10.5)	41/1053 (3.9)	86/1148 (7.5)	54/1135 (4.8)	67/1059 (6.3)	78/1085 (7.2)
	Rate ratio (95% CI)^e	NA	1.22 (0.82–1.82)	0.43 (0.19–0.99)	0.51 (0.28–0.93)	0.32 (0.18–0.58)	0.51 (0.30–0.85)	0.57 (0.34–0.95)
	Within-group P value^c	NA	.32	.05	.03	.0001	.01	.03
Month 12	N	NA	36	36	39	38	37	38
	Proportion (%)^d	NA	79/1000 (7.9)	40/1002 (4.0)	76/1089 (7.0)	66/1068 (6.2)	46/1043 (4.4)	71/1060 (6.7)
	Rate ratio (95% CI)^e	NA	0.95 (0.54–1.66)	0.42 (0.18–0.96)	0.46 (0.23–0.92)	0.42 (0.21–0.83)	0.35 (0.18–0.71)	0.53 (0.31–0.89)
	Within-group P value^c	NA	.85	.04	.03	.01	.003	.02

Abbreviations: CI, confidence interval; HSV-1, herpes simplex virus type 1; NA, not applicable.

^aData are number of swab specimens testing positive for HSV/total number of swab specimens tested (%).

^bShedding rate ratios were calculated as the proportion of swab specimens testing positive for HSV/proportion testing positive at baseline.

^cPercentage ratios and P values were based on a Poisson mixed model with treatment group, visit, and treatment group by visit interaction (fixed effects) and subject (random effect). Statistically significant P values are in bold.

^dData are number of swabbing days on which a lesion was detected/total number of swabbing days (%).

^eLesion rate ratios were calculated as the proportion of swabbing days on which a lesion was detected/proportion of swabbing days at baseline.

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