Immunogenicity and safety of the new MMR vaccine containing measles AIK-C, rubella Takahashi, and mumps RIT4385 strains in Japanese children: a randomized phase I/II clinical trial

Figures & data

Table 1. Background of the subjects.

	JVC-001 (n = 50)	MR+Mumps (n = 50)
Mean Age ± SD	12.9 ± 1.1 months	13.3 ± 1.7 months
Sex: n, Male/Female	26/24	29/21
Height: Mean,(min-max)	73.9 cm(67.8–81.0 cm)	75.2 cm(70.1–82.3 cm)
Body weight: Mean,(min-max)	9.3 kg(7.0–12.0 kg)	9.6 kg(7.6–11.9 kg)

Table 2. The immunogenicity against measles and rubella after vaccination.

	JVC-001 (n = 49)	MR+Mumps (n = 50)
NT against measles virus
Seroconversion rate *	49/49 (100%, [94.1–100%])	50/50 (100%, [94.2–100%])
GMT at Day 42	43.1, [95% CI: 37.4–49.6]	39.9, [95% CI: 33.1–48.2]
HI against rubella virus
Seroconversion rate *	49/49 (100%, [94.1–100%])	50/50 (100%, [94.2–100%])
GMT at Day 42	91.2, [95% CI: 77.0–107.9]	76.6 [95% CI: 64.2–91.5]

*: (Seroconversion rate, [95% confidence interval])

Note: See immunological assessment section for the definition of seroconversion rate. Population parameters of each seroconversion rate were calculated based on each definition with each cut-off value in pre-immunization. Subjects whose assay data was failed to obtain were also eliminated from the calculation.

Table 3. Immunogenicity against different mumps genotypes and ELISA antibodies.

Mumps NT against	JVC-001 (n = 49)	MR+Mumps (n = 50)
Genotype A
Seroconversion rate	41/48 (85.4%, [72.2–93.9%])	28/50 (56.0%, [41.3–70.0%])
GMT at Day 42	19.9, [95% CI: 13.2–29.9]	5.8 [95% CI: 4.0–8.4]
Genotype B
Seroconversion rate	41/48 (85.4%, [72.2–93.9%])	33/50 (66.0%, [51.2–78.8%])
GMT at Day 42	15.8, [95% CI: 10.9–22.8]	6.8, [95% CI: 4.8–9.6]
Genotype G
Seroconversion rate	37/48 (77.1%, [62.7–88.0%])	32/49 (65.3%, [50.4–78.3%])
GMT at Day 42	12.5, [95% CI: 8.6–18.3]	7.1, [95% CI: 5.0–10.1]
Genotype D
Seroconversion rate	39/43 (90.7%, [77.9−97.4%])	46/48 (95.8%, [85.8–99.5%])
Seroresponse rate	38/43 (88.4%, [74.9–96.1%])	42/48 (87.5%, [74.8–95.3%])
GMT at Day 42	32.1, [95% CI: 19.6–52.4]	31.4, [95% CI:19.6–50.5]
Mumps ELISA	JVC-001 (n = 49)	MR+Mumps (n = 50)
Seroconversion rate	45/48 (93.8%, [82.8–98.7%])	46/49 (93.9%, [83.1–98.7%])
GMT at Day 42	1745.0, [95% CI: 1250.2–2435.5]	1400.4, [95% CI: 964.6–2033.0]

Note: See immunological assessment section for the definition of seroconversion/seroresponse rate. Population parameters of each seroconversion/seroresponse rate were calculated based on each definition with each cut-off value in pre-immunization. Subjects whose assay data was failed to obtain were also eliminated from the calculation.

Table 4. Incidence of solicited local adverse events.

	JVC-001		Mumps		MR
	(N = 50)		(N = 50)		(N = 50)
	n (%)	(95% CI)	n (%)	(95% CI)	n (%)	(95% CI)
Redness (erythema)	19 (38.0)	(24.7−52.8%)	23 (46.0)	(31.8–60.7%)	20 (40.0)	(26.4–54.8%)
Swelling	5 (10.0)	(3.3–21.8%)	8 (16.0)	(7.2–29.1%)	9 (18.0)	(8.6–31.4%)
Pain	5 (10.0)	(3.3–21.8%)	3 (6.0)	(1.3–16.5%)	3 (6.0)	(1.3–16.5%)
Total	21 (42.0)	(28.2–56.8%)	23 (46.0)	(31.8–60.7%)	21 (42.0)	(28.2–56.8%)

Table 5. Incidence of solicited systemic adverse events and reactions.

		JVC-001 (N = 50)		MR+Mumps (N = 50)
		n (%)	95% CI	n (%)	95% CI
Fever	adverse events adverse reaction	35 (70.0) 15 (30.0)	(55.4 - 82.1%) (17.9 - 44.6%)	33 (66.0) 8 (16.0)	(51.2 -78.8%) (7.2 - 29.1%)
measles/rubella-like rash	adverse events adverse reaction	2 (4.0) 2 (4.0)	(0.5 - 13.7%)	3 (6.0) 3 (6.0)	(1.3 - 16.5%) (1.3 - 16.5%)
			(0.5 - 13.7%)
Other rash	adverse events adverse reaction	10 (20.0) 1 (2.0)	(10.0 - 33.7%) (0.1 - 10.6%)	11 (22.0) 2 (4.0)	(11.5 - 36.0%) (0.5 - 13.7%)
Parotid/salivary gland swelling	adverse events adverse reaction	0 (0.0) 0 (0.0)	(0.0 - 5.8%) (0.0 - 5.8%)	0 (0.0) 0 (0.0)	(0.0 - 5.8%) (0.0 - 5.8%)
Signs indicative of aseptic meningitis	adverse events adverse reaction	0 (0.0) 0 (0.0)	(0.0 - 5.8%) (0.0 - 5.8%)	0 (0.0) 0 (0.0)	(0.0 - 5.8%) (0.0 - 5.8%)
Total	adverse events adverse reaction	38 (76.0) 18 (36.0)	(61.8 - 86.9%) (22.9 - 50.8%)	36 (72.0) 12 (24.0)	(57.5 - 83.8%) (13.1 - 38.2%)

Table 6. Comparison of the components of measles, rubella, and mumps vaccine strain.

	JVC-001	MR	Monovalent mumps
Measles	AIK-C ≥ 10^3.7 CCID50	AIK-C ≥ 5000 FFU	–
Rubella	Takahashi ≥ 10^3.0 CCID50	Takahashi ≥ 1000 FFU	–
Mumps	RIT4385 ≥ 10^3.7 CCID50	–	Hoshino ≥ 5000 CCID50