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An open-label, randomized, clinical study assessing the safety and immunogenicity of JVC-001 in Japanese healthy children

Phase I/II clinical study of JVC-001

100

An open-label, randomized, clinical study assessing the safety and immunogenicity of JVC-001 in Japanese healthy children

100 subjects who obtained informed consent from proxies were enrolled in this study (JVC-001 group: 50, control group: 50). All enrolled subjects were vaccinated and the study was completed. None of the subjects discontinued during the study period.

In safety analysis set (JVC-001 group: 50 subjects, control group: 50 subjects) of Japanese healthy children injected JVC-001 or control vaccines, following safety results were obtained. - No death and SAE was observed in JVC-001 group and in the control group. - Incidences of AEs in throughout the study period were 94.0% (47/50) in JVC-001 group and 92.0% (46/50) in the control group. - Incidences of solicited local AEs were 42.0% (21/50) in JVC-001 group. 46.0% (23/50) on the mumps vaccine side and 42.0% (21/50) on the MR vaccine side in the control group. - Incidences of solicited general AEs were 76.0% (38/50) in JVC-001 group and 72.0% (36/50) in the control group.

In PPS (JVC-001 group: 49 subjects, control group: 50 subjects) of Japanese healthy children injected JVC-001 or control vaccines, following immunogenicity results were obtained. 1) Anti-measles virus antibody (CPE-NT method) Seroconversion rate and GMT on Day 42 were 100.0% (95% CI: 94.07-100.00%) and 43.1 fold dilution (95% CI: 37.41-49.58 fold dilution) in JVC-001 group and 100.0% (95% CI: 94.18-100.00%) and 39.9 fold dilution (95% CI: 33.08-48.23 fold dilution) in the control group. 2) Anti-rubella virus antibody (HI method) Seroconversion rate and GMT on Day 42 were 100.0% (95% CI: 94.07-100.00%) and 91.2 fold dilution (95% CI: 77.04-107.85 fold dilution) in JVC-001 group and 100.0% (95% CI: 94.18-100.00%) and 76.6 fold dilution (95% CI: 64.20-91.49 fold dilution) in the control group. 3) Anti-mumps virus antibody (Genotype D)(unenhanced PRNT method) Seroresponse rate and GMT on Day 42 were 88.4% (95% CI: 74.92-96.11%) and 32.09 ED50 (95% CI: 19.646-52.413 ED50) in JVC-001 group and 87.5% (95% CI: 74.75-95.27%) and 31.44 ED50 (95% CI: 19.565-50.539 ED50) in the control group.

1) Anti-mumps virus antibody (Genotype A)(CPE-NT method) Seroconversion rate and GMT on Day 42 were 85.4% (95% CI: 72.24-93.93%) and 19.9 fold dilution (95% CI: 13.20-29.92 fold dilution) in JVC-001 group and 56.0% (95% CI: 41.25-70.01%) and 5.8 fold dilution (95% CI: 4.03-8.40 fold dilution) in the control group. 2) Anti-mumps virus antibody (Genotype B)(CPE-NT method) Seroconversion rate and GMT on Day 42 were 85.4% (95% CI: 72.24-93.93%) and 15.8 fold dilution (95% CI: 10.92-22.78 fold dilution) in JVC-001 group and 66.0% (95% CI: 51.23-78.79%) and 6.8 fold dilution (95% CI: 4.80-9.55 fold dilution) in the control group. 3) Anti-mumps virus antibody (Genotype G)(CPE-NT method) Seroconversion rate and GMT on Day 42 were 77.1% (95% CI: 62.69-87.97%) and 12.5 fold dilution (95% CI: 8.57-18.29 fold dilution) in JVC-001 group and 65.3% (95% CI: 50.36-78.33%) and 7.1 fold dilution (95% CI: 5.03-10.14 fold dilution) in the control group. 4) Anti-mumps virus antibody (Genotype A)(ELISA method) Seroconversion rate and GMT on Day 42 were 93.8% (95% CI: 82.80-98.69%) and 1745.0 (95% CI: 1250.22-2435.53) in JVC-001 group and 93.9% (95% CI: 83.13-98.72%) and 1400.4 (95% CI: 964.60-2032.97) in the control group.

JVC-001 or control vaccines were injected once each subcutaneously in Japanese healthy children. Day 42, antibody titers against measles, rubella and mumps viruses antigens were measured. Seroconversion rate of antibodies against measles virus and rubella virus were 100% in both groups, and seroresponse rate and GMT for anti-mumps virus antibody by the unenhanced PRNT method were at sufficient levels in both groups. The incident of most AEs were comparable in both groups.

April. 22, 2019

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6605871/

Yes

Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ Supporting Documents: - Study Protocol - Statistical Analysis Plan - Clinical Study Report Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

Oct. 15, 2015

Interventional

multi-center, active control, two-step enrollment, randomized, open-label study

prevention purpose

1-2

Aged 12 months and older and younger than 24 months

1) Subjects with history of measles, mumps, or rubella infection
2) Subjects with history of measles, mumps, or rubella virus vaccination

Both

Prevention of measles, mumps and rubella

investigational material(s)
Generic name etc : JVC-001
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : subcutaneous injection

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
efficacy
1) immunogenicity against measles virus, rubella virus and mumps virus (Genotype D)
2) Adverse events, solicited adverse events/symptoms (local, general)

efficacy
immunogenicity against several genotypes of mumps viruses

-

Sept. 29, 2015