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Long term follow-up for infants who was enrolled at 2 months of age into 'Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants' - Long term follow-up for infants who was enrolled at 2 months of age into 'Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants'

开始日期2015-08-26

申办/合作机构

Japan Vaccine Co., Ltd.

100 项与 Japan Vaccine Co., Ltd. 相关的临床结果

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0 项与 Japan Vaccine Co., Ltd. 相关的专利（医药）

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6

项与 Japan Vaccine Co., Ltd. 相关的文献（医药）

2019-05-04·Human Vaccines & Immunotherapeutics3区 · 医学

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

3区 · 医学

Article

作者: Eda, Masahiro ; Nakayama, Tetsuo ; Hirano, Motonori ; Goto, Wakako

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.

2018-03-20·Kansenshogaku Zasshi

Efficacy, Safety and Immunogenicity of a Novel Adjuvanted Subunit Herpes Zoster Vaccine in Japanese Aged 50 Years and 70 Years and Older

作者: OGAWA, Masayuki ; KOVAC, Martina ; HIRANO, Motonori ; YAMASHITA, Nobuyuki ; WATANABE, Daisuke ; IKEMATSU, Hideyuki

2017-03-04·Human Vaccines & Immunotherapeutics3区 · 医学

Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged ≥50 years when administered subcutaneously vs. intramuscularly

3区 · 医学

Article

作者: Heineman, Thomas ; Shiramoto, Masanari ; Eda, Masahiro ; Ogawa, Masayuki ; Douha, Martine ; Lal, Himal ; Vink, Peter

The impact of alternate routes of vaccine administration, subcutaneous (SC) or intramuscular (IM), on the safety and immunogenicity of herpes zoster subunit candidate vaccine (HZ/su) was assessed in Japanese adults aged ≥ 50 y. During this phase III open-label study, 60 subjects were randomized (1:1) to receive HZ/su through SC or IM routes in a 0, 2 month schedule. Vaccine response rates (VRRs) and geometric mean concentrations (GMCs) of varicella zoster virus glycoprotein E (gE)-specific antibodies were determined by ELISA. Solicited and unsolicited symptoms were recorded for 7 and 30 d after each vaccination and graded 1-3 in severity. Serious adverse events (SAEs) were recorded throughout the study. At one month post-dose 2, VRRs were 100% (95% Confidence Interval (CI): 88.1-100) in both groups; anti-gE antibody GMCs were 44126.1 mIU/ml (95% CI: 36326.1-53601.0) and 45521.5 mIU/ml (95% CI; 37549.5-55185.9) in the SC and IM groups, respectively. Injection site reactions (pain, swelling and redness) were common, and observed more frequently following SC administration. Grade 3 redness and swelling were more frequently observed after SC administration. Fatigue and headache were the most frequently reported general symptoms for both routes of administration. Ten and 7 unsolicited AEs were reported in the SC and IM group, respectively. Two unsolicited AEs (1 in SC; 1 in IM) were considered related to vaccination by the investigator. Three non-fatal SAEs considered unrelated to vaccination were reported during the study. Administration of the HZ/su vaccine candidate resulted in a substantial immune response that was comparable between SC and IM subjects, but local reactogenicity may be greater for SC.

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