Safety and immunogenicity of a live attenuated mumps vaccine

Figures & data

Figure 1. Summary of the trial design. * A dose:3.50 ± 0.25 logCCID50/ml, B dose:4.25 ± 0.25 logCCID50/ml, C dose:5.00 ± 0.25 logCCID50/ml. (A) Adult: 16 y-old~ < 60 y-old. (B) Child: 5 y-old~ < 16 y-old. (C) Preschool: 2 y-old~ < 5 y-old. (D) Infant: 8 mo-old~ < 2 y-old.

Table 1. The description of baseline level before immunization

Age group		16~60 y (n = 66)	5~16 y (n = 66)	2~5 y (n = 84)	8~24 mo (n = 84)
Sex	Male	18(27%)	26(39%)	41(48%)	45(53%)
	Female	48(73%)	40(60%)	43(51%)	39(46%)
Age	Mean ± SD	41.6 ± 11.1	8.3 ± 2.2	3.5 ± 0.9	1.4 ± 0.4
	Range	43.1	9.3	2.9	1.3
	Median	42.2	7.9	3.3	1.4
Pre-vaccination antibody titer*	Negative	27	41	59	73
	Positive	39	25	25	11
	Range	1:4~1:32	1:4~1:32	1:4~1:64	1:4~1:32
The assignment of the various treatment	Intervention A**	n = 16	n = 16	n = 16	n = 16
	Intervention B**	n = 16	n = 16	n = 16	n = 16
	Intervention C**	n = 16	n = 16	n = 16	n = 16
	Intervention D**	n = 18	n = 18	n = 18	n = 18
	Intervention E**	/	/	n = 18	n = 18

* Pre-vaccination on antibody titer: Neutralizing antibodies against SP-A virus. **Intervention A: A dose of vaccine candidate (3.5 ± 0.25 logCCID50). Intervention B: B dose of vaccine candidate (4.3 ± 0.25 logCCID50). Intervention C: A dose of vaccine candidate (5.0 ± 0.25 logCCID50). Intervention D: Placebo

Intervention E: A commercial live attenuated mumps vaccine contains genotype A strain (S79) as positive control.

Figure 2. Seroconversion rates of serum 28 d after vaccination in C dose, placebo and control groups. Containing individuals (A) 16–60 y old, (B) 5–16 y old, (C) 2–5 y old and (D) 8–24 mo old. Detection of antibody, including the neutralizing antibodies against SP-A virus and S79 virus, and the antibody detected by ELISA. The genotype A vaccine control group was added in the 2–5-y-old and 8–24-mo-old groups. Seroconversion definition: ELISA:An antibody titer > 12 U/ml was considered seropositive. Neutralizing antibody: An antibody titer > 1:4 was considered seropositive.

Table 2. Immunogenicity of mumps attenuated vaccine(GMT,95%CI)

Method	Group of age	/	C dose	Control	Placebo
ELISA*	16~60 y	GMT	120.1	/	39.5
		95%CI	86.2,154.0	/	1.1,77.9
	5~16 y	GMT	210.3	/	97.7
		95%CI	187.7,232.8	/	38.9,156.5
	2~5 y	GMT	60.0	28.3	9.7
		95%CI	14.6,105.4	1.5,55.1	0.6,18.8
	8~24 mo	GMT	123.6	203.1	49.4
		95%CI	59.1,188.1	92.6,313.9	0.8,98
Neutralizing antibodies against the SP virus ** (F-genotype)	16~60 y	GMT	14.1	/	5.7
		95%CI	8.6,22.9	/	2.1,15.4
	5~16 y	GMT	14.1	/	5.7
		95%CI	8.3,23.8	/	1.7,18.7
	2~5 y	GMT	10.8	5.0	3.2
		95%CI	5.1,23.2	1.1,22.6	1.0,10.4
	8~24 mo	GMT	8.7	10.1	4.0
		95%CI	3.9,19.3	1.1,90.1	1.3,12.3
Neutralizing antibodies against the S79 virus*** (A-genotype)	16~60 y	GMT	5.4	/	2.8
		95%CI	3.7,7.9	/	1.9,4.2
	5~16 y	GMT	15.3	/	8.0
		95%CI	10.3,22.7	/	2.9,22.4
	2~5 y	GMT	7.3	7.1	3.6
		95%CI	4.0,13.6	0.9,54.1	1.4,9.4
	8~24 mo	GMT	6.4	10.1	4.5
		95%CI	3.4,12.1	1.5,65.9	1.7,11.8

Immunological detection includes three methods: ELISA, the neutralization assay with SP-A virus, and the neutralization assay with S79 virus. The table shows the GMT and 95% CI values of each age group and each dose group. * ELISA: U/ml. ** Neutralizing antibodies against the SP virus,the neutralization assay was performed on Vero cells using diluted 200–500 CCID50 SP-A virus. *** Neutralizing antibodies against the S79 virus,the neutralization assay was performed on Vero cells using diluted 200–500 CCID50 S79 virus.

Table 3. Adverse events and serious adverse events among subjects receiving vaccine or placebo or control (number of cases and occurrence

	Vaccine group								Control group (n = 36)		Placebo group (n = 72)
	A dose (n = 64)			B dose (n = 64)		C dose (n = 64)
	No.	(%)		No.	(%)	No.	(%)		No.	(%)	No.		(%)
All local and systemic adverse events	25	39		27	42	23	35		14	38	18		40
Solicited systemic adverse events after injection
Fever	18	28	16		25	13		20	10	27		19	26
Fever ≥ 3grades	1	1	0		0	0		0	0	0		0	0
Diarrhea	1	1	1		1	0		0	1	2		1	1
Diarrhea ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Nausea/vomiting/anorexi	1	1	3		4	0		0	1	2		2	2
Nausea/vomiting/anorexia ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Irritability/Drowsiness/acratia	0	0	4		6	4		6	0	0		1	1
Irritability/Drowsiness/acratia ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Allergy	1	1	0		0	0		0	0	0		0	0
Allergy ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Cough	7	11	9		14	6		8	4	11		9	12
Cough ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Muscle pain	0	0	0		0	1		1	0	0		1	1
Muscle pain ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Solicited local adverse events after each injection
Pain	0	0	3		4	5		7	1	2		2	2
Pain ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Redness	1	1	0		0	4		6	1	2		1	1
Redness ≥ 3grades	0	0	0		0	0		0	1	2		0	0
Swelling	1	1	0		0	1		1	1	2		0	0
Swelling ≥ 3grades	0	0	0		0	0		0	1	2		0	0
Itching	0	0	0		0	1		1	0	0		0	0
Itching ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Scleroma	1	1	0		0	5		7	0	0		0	0
Scleroma ≥ 3grades	0	0	0		0	1		1	0	0		1	1
Rash	0	0	0		0	0		0	0	0		0	0
Rash ≥ 3grades	0	0	0		0	0		0	0	0		0	0
Mumps-specific adverse events
Orchitis	0	0	0		0	0		0	0	0		0	0
Parotitis	0	0	0		0	0		0	0	0		0	0
Meningitis	0	0	0		0	0		0	0	0		0	0
Pancreatitis	0	0	0		0	0		0	0	0		0	0

Systemic adverse events, local adverse events and Mumps-specific adverse events of each participant were monitored at 4, 7, 10, 14, and 28 d post-vaccination. The table shows the sum of all adverse events within 28 d.