PMID- 30724658
OWN - NLM
STAT- MEDLINE
DCOM- 20200228
LR  - 20200309
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 15
IP  - 5
DP  - 2019
TI  - 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.
PG  - 1139-1144
LID - 10.1080/21645515.2019.1578591 [doi]
AB  - Domestic measles, mumps, and rubella combined (MMR) vaccines were discontinued in 
      1993 in Japan because of the unexpected high incidence of aseptic meningitis. The 
      introduction of an effective MMR vaccine with lower reactogenicity has been 
      expected. A new MMR vaccine (JVC-001) was developed, using mumps RIT4385 strain 
      in combination with Japanese measles AIK-C strain and rubella Takahashi strain 
      (MR) vaccine. An open-label, randomized, phase I/II clinical study was conducted 
      in 100 healthy Japanese children equally randomized to a JVC-001 group and an MR 
      with monovalent mumps vaccine (Hoshino strain) group. Immunogenicity was assessed 
      using a neutralization test (NT) for measles, hemagglutination inhibition (HI) 
      test for rubella, and NT and enzyme-linked immune-sorbent assay (ELISA) for mumps 
      strain with different genotypes (genotype A, B, D and G) on Day 0 and Day 42-56. 
      Solicited and unsolicited adverse events (AEs) were recorded. Seroconversion 
      rates of measles and rubella were both 100%. JVC-001 induced higher 
      immunogenicity against mumps virus genotype G with seroconversion rate of 77.1% 
      (95% confidence interval [CI]: 62.7-88.0%) compared to 65.3% (95% CI: 50.4-78.3%) 
      in the control group. Geometric mean titer (GMT) was 12.5 (95% CI: 8.6-18.3) in 
      the JVC-001 group and 7.1 (95% CI: 5.0-10.1) in the control group. JVC-001 also 
      induced good immunogenicity against other genotypes (A, B and D). There was no 
      apparent difference in the incidence of AEs between JVC-001 and the control 
      groups. JVC-001 is safe and induces effective immunogenicity against measles, 
      mumps, and rubella compared with the currently marketed vaccines in Japan.
FAU - Nakayama, Tetsuo
AU  - Nakayama T
AD  - a Kitasato Institute for Life Sciences, Laboratory of Viral Infection , Tokyo , 
      Japan.
FAU - Eda, Masahiro
AU  - Eda M
AD  - b Japan Vaccine Co., Ltd , Tokyo , Japan.
FAU - Hirano, Motonori
AU  - Hirano M
AD  - b Japan Vaccine Co., Ltd , Tokyo , Japan.
FAU - Goto, Wakako
AU  - Goto W
AD  - b Japan Vaccine Co., Ltd , Tokyo , Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190422
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
SB  - IM
MH  - Antibodies, Neutralizing/blood
MH  - Antibodies, Viral/*blood
MH  - Female
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Infant
MH  - Japan
MH  - Male
MH  - Measles/*prevention & control
MH  - Measles-Mumps-Rubella Vaccine/administration & dosage/*immunology
MH  - Mumps/*prevention & control
MH  - Rubella/*prevention & control
MH  - Seroconversion
MH  - Vaccination
PMC - PMC6605871
OTO - NOTNLM
OT  - Immunogenicity
OT  - MMR
OT  - RIT4385
OT  - mumps virus genotype G
OT  - neutralizing antibody
EDAT- 2019/02/07 06:00
MHDA- 2020/02/29 06:00
PMCR- 2019/04/22
CRDT- 2019/02/07 06:00
PHST- 2019/02/07 06:00 [pubmed]
PHST- 2020/02/29 06:00 [medline]
PHST- 2019/02/07 06:00 [entrez]
PHST- 2019/04/22 00:00 [pmc-release]
AID - 1578591 [pii]
AID - 10.1080/21645515.2019.1578591 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2019;15(5):1139-1144. doi: 10.1080/21645515.2019.1578591. 
      Epub 2019 Apr 22.