Safety and immunogenicity of a novel oral hexavalent rotavirus vaccine：a phase I clinical trial

Figures & data

Figure 1. Trial profile

Table 1. Summary of demographic characteristics-adult cohort

	High-dose group (N=20)	Placebo 1 (N=10)	Placebo 2 (N=10)	P
Sex, n(%)
Male	9(45.00)	3 (30.00)	3 (30.00)	0.76
Female	11(55.00)	7 (70.00)	7 (70.00)
Age, weeks				0.65
Mean (SD)	39.06 (8.33)	39.12 (7.80)	36.53 (5.07)
Race, n(%)				1.00
Han	20 (100.00)	10 (100.00)	10 (100.00)
Height, cm				0.72
Mean (SD)	162.95 (8.89)	165.40 (8.19)	162.90 (7.40)
Weight, kg				0.12
Mean (SD)	63.98 (12.68)	71.65 (12.43)	60.55 (10.68)

Table 2. Summary of demographic characteristics-toddler cohort

	High-dose group(N=20)	Placebo 1(N=10)	Placebo 2(N=10)	P
Sex, n(%)
Male	10 (50.00)	1 (10.00)	7 (70.00)	0.02
Female	10 (50.00)	9 (90.00)	3 (30.00)
Age, weeks				0.65
Mean (SD)	4.83 (1.22)	4.54 (1.29)	5.04 (1.08)
Race, n(%)				1.00
Han	20 (100.00)	10 (100.00)	10 (100.00)
Height, cm				0.78
Mean (SD))	107.60 (10.13)	106.60 (11.61)	109.80 (10.02)
Weight, kg				0.94
Mean (SD)	17.61 (3.66)	17.71 (4.40)	18.15 (4.20)

Table 3. Summary of demographic characteristics-infant cohort

	low-dose group (N=20)	Intermadiate-dose group (N=20)	High-dose group (N=20)	Placebo 1 (N=30)	Placebo 2 (N=30)	P
Sex, n(%)						0.09
Male	16(80.00)	9(45.00)	8(40.00)	15(50.00)	17(56.67)
Female	4(20.00)	11(55.00)	12(60.00)	15(50.00)	13(43.33)
Age, weeks						0.69
Mean (SD)	9.88(1.34)	9.48(1.14)	9.29(1.03)	9.39(1.54)	9.48(1.43)
Race, n(%)						0.28
Han	20(100.00)	19(95.00)	20(100.00)	30(100.00)	30(100.00)
Mongolian	0.00(0.00)	1.00(5.00)	0.00(0.00)	0.00(0.00)	0.00(0.00)
Height, cm						0.05
Mean (SD)	60.60(2.04)	59.95(2.44)	58.55(2.31)	58.93(2.41)	59.27(2.61)
Weight, kg						0.52
Mean (SD)	6.26(0.86)	5.96(0.72)	6.04(0.91)	5.98(0.68)	5.87(0.75)

Table 4. Summary of adverse enents (AEs) –adult and toddler cohort

		High-dose group (N=20)		Placebo 1 (N=10)		Placebo 2 (N=10)
cohort	AEs	n	%	n	%	n	%	P
Adult	Solicited AE	2	10.00	1	10.00	1	10.00	1.00
	Unsolicited AE	3	15.00	0	0.00	3	7.50	0.41
Toddler	Solicited AE	7	35.00	5	50.00	2	20.00	0.40
	Unsolicited AE	8	40.00	2	20.00	2	20.00	0.48

Table 5. Summary of adverse enents (AEs) –infant cohort

	low-dose group (N=20)		Intermadiate-dose group (N=20)		High-dose group (N=20)		Placebo 1 (N=30)		Placebo 2 (N=30)
	n	%	n	%	n	%	n	%	n	%	P
With one or more AE	19	95.00	18	90.00	19	95.00	26	86.67	24	80.00	0.42
With vaccination-related AE	11	55.00	13	65.00	16	80.00	15	50.00	18	60.00	0.29
With vaccination-irrelevant AE	13	65.00	14	70.00	13	65.00	21	70.00	18	60.00	0.93
Discontinued due to an AE	0	0.00	3	15.00	2	10.00	1	3.33	1	3.33	0.23
With serious AE	1	5.00	2	10.00	0	0.00	2	6.67	0	0.00	0.36
Solicited AE	12	60.00	15	75.00	16	80.00	17	56.67	19	63.33	0.40
Unsolicited AE	13	65.00	13	65.00	13	65.00	21	70.00	18	60.00	0.96

Table 6. Summary of solicited adverse enents (AEs) –infant cohort

	low-dose group			Intermadiate-dose group			High-dose group			Placebo 1			Placebo 2
	N	n	%	N	n	%	N	n	%	N	n	%	N	n	%	P
Fever
Post1 Dose	20	5	25.00	20	6	30.00	20	12	60.00	30	7	23.30	30	10	33.33	0.08
Post2 Dose	20	6	30.00	15	3	20.00	18	7	38.89	28	2	7.14	29	4	13.79	0.06
Post3 Dose	20	3	15.00	15	3	20.00	18	5	27.78	28	7	25.00	28	8	28.57	0.83
Post any Dose	20	10	50.00	20	10	50.00	20	14	70.00	30	12	40.00	30	15	50.00	0.36
Diarrhoea
Post1 Dose	20	3	15.00	20	6	30.00	20	6	30.00	30	6	20.00	30	4	13.33	0.48
Post2 Dose	20	1	5.00	15	2	13.33	18	4	22.22	28	4	14.29	29	3	10.34	0.60
Post3 Dose	20	2	10.00	15	0	0.00	18	2	11.11	28	3	10.71	28	1	3.57	0.59
Post any Dose	20	3	15.00	20	8	40.00	20	8	40.00	30	9	30.00	30	7	23.33	0.32
Vomiting
Post1 Dose	20	1	5.00	20	2	10.00	20	2	10.00	30	0	0.00	30	0	0.00	0.19
Post2 Dose	20	0	0.00	15	0	0.00	18	1	5.56	28	1	3.57	29	0	0.00	0.55
Post3 Dose	20	1	5.00	15	0	0.00	18	1	5.56	28	0	0.00	28	0	0.00	0.43
Post any Dose	20	2	10.00	20	2	10.00	20	2	10.00	30	1	3.33	30	0	0.00	0.39
Anorexia
Post1 Dose	20	1	5.00	20	0	0.00	20	1	5.00	30	1	3.33	30	1	3.33	0.90
Post2 Dose	20	0	0.00	15	0	0.00	18	0	0.00	28	1	3.57	29	0	0.00	0.57
Post3 Dose	20	0	0.00	15	0	0.00	18	0	0.00	28	1	3.57	28	0	0.00	0.57
Post any Dose	20	1	5.00	20	0	0.00	20	1	5.00	30	2	6.67	30	1	3.33	0.83
Irritability/abnormal crying
Post1 Dose	20	1	5.00	20	1	5.00	20	0	0.00	30	3	10.00	30	1	3.33	0.59
Post2 Dose	20	0	0.00	15	0	0.00	18	2	11.11	28	1	3.57	29	0	0.00	0.16
Post3 Dose	20	0	0.00	15	0	0.00	18	0	0.00	28	1	3.57	28	0	0.00	0.57
Post any Dose	20	1	5.00	20	1	5.00	20	2	10.00	30	3	10.00	30	1	3.33	0.81
Drowsiness
Post1 Dose	20	1	5.00	20	0	0.00	20	3	15.00	30	0	0.00	30	1	3.33	0.09
Post2 Dose	20	0	0.00	15	0	0.00	18	2	11.11	28	1	3.57	29	0	0.00	0.16
Post3 Dose	20	0	0.00	15	0	0.00	18	1	5.56	28	1	3.57	28	0	0.00	0.55
Post any Dose	20	1	5.00	20	0	0.00	20	4	20.00	30	1	3.33	30	1	3.33	0.06
Allergy
Post1 Dose	20	0	0.00	20	0	0.00	20	0	0.00	30	0	0.00	30	0	0.00	1.00
Post2 Dose	20	0	0.00	15	0	0.00	18	0	0.00	28	1	3.57	29	0	0.00	0.57
Post3 Dose	20	0	0.00	15	0	0.00	18	0	0.00	28	0	0.00	28	0	0.00	1.00
Post any Dose	20	0	0.00	20	0	0.00	20	0	0.00	30	1	3.33	30	0	0.00	0.55

Figure 2. Seroconversion rates in serum at 28 days after the last vaccination in vaccine and placebo groups (infants)

Table 7. Summary of IgA response to serotypes G1, G2, G3, G4, G8 and G9 in the per-protocol immunogenicity popolation–infant cohort

		Low-dose group (N=19)		Intermadiate-dose group (N=11)		High-dose group (N=17)		Placebo 1 (N=24)		Placebo 2 (N=26)
Serotype	Parameter	GMC	95%CI	GMC	95%CI	GMC	95%CI	GMC	95%CI	GMC	95%CI
G1	Baseline	10.00	10.00-10.00	11.89	8.09-17.48	10.53	9.44-11.74	10.00	10.00-10.00	10.43	9.56-11.38
	PD3	38.96	18.97-80.03	44.87	15.97-126.04	153.46	83.35-282.55	10.33	9.66-11.06	10.85	9.65-12.20
G2	Baseline	10.00	10.00-10.00	11.70	8.25-16.58	10.55	9.41-11.83	10.00	10.00-10.00	10.53	9.47-11.70
	PD3	39.88	18.86-84.29	48.32	16.42-142.14	154.72	85.68-279.38	10.35	9.64-11.12	10.75	9.68-11.94
G3	Baseline	10.00	10.00-10.00	11.08	8.81-13.94	10.00	10.00-10.00	10.00	10.00-10.00	10.00	10.00-10.00
	PD3	25.90	13.50-49.70	31.23	13.66-71.36	77.64	44.02-136.91	10.00	10.00-10.00	10.68	9.72-11.73
G4	Baseline	10.00	10.00-10.00	11.87	8.10-17.40	10.55	9.41-11.83	10.00	10.00-10.00	10.49	9.50-11.59
	PD3	40.60	19.23-85.74	49.46	16.39-149.29	165.02	86.49-314.88	10.35	9.64-11.12	11.27	9.50-13.37
G8	Baseline	10.00	10.00-10.00	11.85	8.11-17.32	10.42	9.55-11.36	10.00	10.00-10.00	10.53	9.47-11.70
	PD3	40.04	19.32-82.96	45.21	16.03-127.49	173.06	91.46-327.47	10.37	9.62-11.18	10.99	9.58-12.61
G9	Baseline	10.00	10.00-10.00	12.55	8.59-18.34	10.62	9.34-12.08	10.00	10.00-10.00	10.88	9.60-12.34
	PD3	41.88	19.87-88.26	45.15	15.82-128.90	179.48	97.09-331.81	10.54	9.46-11.74	10.73	9.68-11.90