Evidence map›Paper›PMID 30724658›Full record

Trial reportHuman vaccines & immunotherapeutics2019

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.

Tetsuo Nakayama, Masahiro Eda, Motonori Hirano, Wakako Goto

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Current Status of Mumps Virus Infection: Epidemiology, Pathogenesis, and Vaccine.International journal of environmental research and public health · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Tetsuo Nakayamaa Kitasato Institute for Life Sciences, Laboratory of Viral Infection , Tokyo , Japan.
Masahiro Edab Japan Vaccine Co., Ltd , Tokyo , Japan.
Motonori Hiranob Japan Vaccine Co., Ltd , Tokyo , Japan.
Wakako Gotob Japan Vaccine Co., Ltd , Tokyo , Japan.
Kitasato Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Immunogenicity, VaccineAntibodies, NeutralizingAntibodies, ViralFemaleHumansInfantJapanMaleMeaslesMeasles-Mumps-Rubella VaccineMumpsRubellaSeroconversionVaccinationAntibodies, NeutralizingAntibodies, ViralMeasles-Mumps-Rubella VaccineImmunogenicityMMRmumps virus genotype Gneutralizing antibodyRIT4385

Identifiers

PMID30724658
PMCPMC6605871
OpenAlexW2914151985

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.