腮腺炎减毒活疫苗 (大连科兴疫苗)(Mumps virus vaccine (Sinovac (Dalian) Vaccine Technology Co. Ltd.))

概要

基本信息

药物类型

减毒活疫苗、预防性疫苗

别名-

靶点-

作用机制

免疫刺激剂

治疗领域

感染口颌疾病

在研适应症

腮腺炎

非在研适应症-

原研机构

科兴（大连）疫苗技术有限公司

在研机构

科兴（大连）疫苗技术有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2011-12-19),

腮腺炎

最高研发阶段(中国)批准上市

特殊审评-

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关联

9

项与腮腺炎减毒活疫苗 (大连科兴疫苗) 相关的临床试验

NCT06208683 / Active, not recruiting临床4期

The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine Administrated Alone and Concomitantly With a Quadrivalent Inactivated Influenza Vaccine in Junior High School Students

This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains

开始日期2023-11-04

申办/合作机构

北京科兴生物制品有限公司

ChiCTR2300073206 / Recruiting临床1期IIT

Phase I clinical trial of recombinant live attenuated mumps vaccine (genotype F)

开始日期2023-09-10

申办/合作机构-

CTR20200383 / Completed临床4期

随机、盲法、阳性对照试验，评价腮腺炎减毒活疫苗与麻腮风联合减毒活疫苗的免疫原性和安全性

评价腮腺炎减毒活疫苗在8~12月龄婴儿中的免疫原性和安全性

开始日期2020-11-18

申办/合作机构

科兴（大连）疫苗技术有限公司

100 项与腮腺炎减毒活疫苗 (大连科兴疫苗) 相关的临床结果

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100 项与腮腺炎减毒活疫苗 (大连科兴疫苗) 相关的转化医学

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100 项与腮腺炎减毒活疫苗 (大连科兴疫苗) 相关的专利（医药）

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330

项与腮腺炎减毒活疫苗 (大连科兴疫苗) 相关的文献（医药）

2025-01-01·Vaccine

Mumps virus neurovirulence assessment-impact of viral doses, animal sex and age on results dispersion

Article

作者: Ivančić-Jelečki, Jelena ; Forčić, Dubravko ; Jagušić, Maja ; Lang Balija, Maja ; Košutić Gulija, Tanja

Mumps epidemics highlight the necessity for new live mumps vaccines. For vaccine candidate neurosafety assessment, the most commonly used test is the rat-based neurovirulence test (RNVT). Its main experimental and ethical deficiency is the results dispersion which requires large number of animals to obtain statistically relevant results. To additionally characterize the RNVT the impact of two experimental animal characteristics, age for inoculation and sex, as well as range of infectious viral doses were analysed. Results obtained from two neurovirulent mumps viruses, SHdeopti-MRV2 and 9218/Zg98, demonstrated no corelation between animal sex and RNVT results (p = 0.9638 and p = 0.3337). Analysis of animal inoculation age found that hydrocephalus formation is impaired in neonatal rats older than 3 days. The inoculation period could be extended from first to the second postanatal day without the impact on RNVT results (p = 0.5865). RNVT results demonstrated robustness to infectious doses in a range from 100 to 1000 PFU, but using the non-standard infectious doses,10 PFU or 100 CCID50, poses a risk of underestimating the neurovirulence potential of the MuV. However, none of the analysed parameters influenced the high dispersion of results. In conclusion, although our finding will facilitate the implementation of the RNVT, the dispersion of the results indicates the need for a better mumps neurovirulence test that would align more closely with the 3R principles.

2024-12-01·Journal of Infection and Chemotherapy

Phase III, open-label, single-arm study of a new MMR vaccine (JVC-001); measles AIK-C, mumps RIT 4385, rubella Takahashi, as a second vaccine dose in healthy Japanese children aged 5–6 years

Article

作者: Kimata, Motoshi ; Sakakibara, Sachiko ; Nakayama, Tetsuo ; Oe, Keiji ; Sogawa, Yoshitaka ; Nakatsu, Takafumi ; Kawamura, Asuka

PURPOSEThis Phase III, multicenter, open-label, single-arm study evaluated the safety and immunogenicity of the measles-mumps-rubella (MMR) combined vaccine, JVC-001, as a second MMR vaccination.METHODSHealthy Japanese children aged 5-6 years received a single dose of JVC-001 following a first measles, mumps, and rubella vaccination (measles-rubella bivalent and mumps monovalent vaccine [Hoshino or Torii strain] or JVC-001) or the MMR vaccine received between ages 1 to <4 years. Immunogenicity was evaluated using antibody titers before and after vaccination (Day 1/Day 43). The primary endpoint was the seroprotection rate of antibody titers against each virus; geometric mean titer (GMT) was also evaluated. Adverse events (AEs) and adverse drug reactions (ADRs) were monitored.RESULTSOne-hundred participants completed the study. The seroprotection rate of antibody titers against measles, rubella, and mumps virus (genotype D) were 100.0 % (95 % confidence interval [CI] 96.4 %, 100.0 %), 100.0 % (95 % CI 96.4 %, 100.0 %), and 100.0 % (95 % CI 96.3 %, 100.0 %), respectively. GMT (fold) increases (Day 1 to Day 43) were 16.0 to 55.7 for measles virus, 35.5 to 99.0 for rubella virus, and 25.7 to 89.5 for mumps virus (genotype D). Solicited ADRs occurred in 40.0 % of participants (injection site, 34.0 %; systemic, 13.0 %).CONCLUSIONSThe second MMR vaccination with JVC-001 demonstrated sufficient antibody coverage against all three viruses; the safety profile was tolerable.CLINICAL TRIAL REGISTRATIONjRCT2080225022.

2024-09-01·American Journal of Infection Control

Changes in the mumps vaccine coverage and incidence of mumps before and after the public subsidization program: A descriptive study using a population-based database in Japan

Article

作者: Sato, So ; Sasabuchi, Yusuke ; Uemura, Kohei ; Yasunaga, Hideo ; Ono, Sachiko

BACKGROUNDContinuous mumps vaccine coverage is essential for eradicating mumps. However, due to safety concerns, Japan's mumps vaccination program transitioned from routine to voluntary. To improve coverage, some municipalities introduced subsidization programs, but the effects on vaccination rates and mumps incidence remain unclear.METHODSIn April 2018, a city in Japan launched a subsidization program for the mumps vaccine for children aged 1-6 years. Using vaccination records and healthcare claims from July 2016 to December 2019, we analyzed changes in vaccination coverage and mumps incidence before and after the program's initiation.RESULTSAt the program's start, mumps vaccination coverage among eligible children was 3.3%, increasing by approximately 1.5% monthly to 38.4% after 21 months. Among 308,976 individuals, 145 mumps cases were identified: 92 cases (0.27 per 1,000 person-years) occurred before, and 53 (0.15 per 1,000 person-years) occurred after the program's start.CONCLUSIONSAlthough the mumps vaccination coverage rate increased following the program's initiation, it remained below the level required for eradication.

100 项与腮腺炎减毒活疫苗 (大连科兴疫苗) 相关的药物交易

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