A群C群脑膜炎球菌结合疫苗（欧林生物）(A/C meningococcal conjugate vaccine(Olymvax Biopharmaceuticals))

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

A群C群脑膜炎球菌多糖结合疫苗（欧林生物）

靶点-

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2020-09-30),

脑膜炎

最高研发阶段(中国)批准上市

特殊审评-

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关联

3

项与 A群C群脑膜炎球菌结合疫苗（欧林生物）相关的临床试验

CTR20234201 / Active, not recruiting临床4期

评价三个批次A群C群脑膜炎球菌多糖结合疫苗在6-11月龄健康婴幼儿中接种的免疫原性的批间一致性和安全性的临床试验

评价成都欧林生物科技股份有限公司生产的三个批次A群C群脑膜炎球菌多糖结合疫苗在6-11月龄婴幼儿中接种的免疫原性的批间一致性和安全性。

开始日期2023-12-06

申办/合作机构

成都欧林生物科技股份有限公司

CTR20232302 / Active, not recruiting临床4期

A群C群脑膜炎球菌多糖结合疫苗在12-23月龄幼儿中不同免疫程序探索的临床试验

探索成都欧林生物科技股份有限公司生产的A群C群脑膜炎球菌多糖结合疫苗在12 -23月龄幼儿中的免疫程序。

开始日期2023-08-10

申办/合作机构

成都欧林生物科技股份有限公司

CTR20160001 / Completed临床3期

对中国3月龄-5周岁健康婴幼儿进行A群C群脑膜炎球菌结合疫苗单中心、随机、盲态、非劣效设计III期临床试验

本研究为单中心、随机盲态、阳性对照、非劣效设计的III期临床试验，用于评价成都欧林生物科技股份有限公司研制的A群C群脑膜炎球菌结合疫苗在中国3月龄-5周岁健康婴幼儿中接种的免疫原性和安全性。

开始日期2016-05-16

申办/合作机构

成都欧林生物科技股份有限公司

100 项与 A群C群脑膜炎球菌结合疫苗（欧林生物）相关的临床结果

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100 项与 A群C群脑膜炎球菌结合疫苗（欧林生物）相关的转化医学

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100 项与 A群C群脑膜炎球菌结合疫苗（欧林生物）相关的专利（医药）

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3

项与 A群C群脑膜炎球菌结合疫苗（欧林生物）相关的文献（医药）

2019-11-01·Letters in Applied Microbiology4区 · 生物学

Preparation and immunological characterization of an inactivated canineClostridium perfringenstype A vaccine

4区 · 生物学

Article

作者: Xing, J. ; Jiang, Q. ; Sun, Y. ; Liu, J. ; Guo, X. ; Ji, X. ; Zhu, L.

Clostridium perfringens is the main cause of sudden death in dogs and currently there is no vaccine to prevent it. In this study, a canine C. perfringens type A strain was used to prepare a vaccine. C. perfringens was inactivated by formaldehyde and adjuvants were added. The safety and immunological characteristics of the inactivated C. perfringens vaccine were evaluated in mice and dogs. The results showed that the C. perfringens vaccine was safe and had immunoprotective activity. The serum antibody titre of immunized mice reached up to 6·25 × 10⁴ . Both single immunization of 4 ml and dual immunizations of 2 ml each provided good immune protection, with five of five immunized dogs surviving. This study also studied a detoxified crude α-toxin extract vaccine. The results showed that a single immunization with 0·5 ml of the detoxified crude α-toxin extract vaccine provided immune protection, with five of five immunized dogs surviving. The inactivated C. perfringens type A vaccine can be used to prevent canine C. perfringens infections. SIGNIFICANCE AND IMPACT OF THE STUDY: Clostridium perfringens is the main cause of sudden death in dogs and currently there is no vaccine to prevent it. In this study, an inactivated canine C. perfringens vaccine and a detoxified crude α-toxin vaccine were prepared. The safety and protective effects of these vaccines were evaluated using mouse and dog models. The vaccines were shown to be safe and to provide immune protection effects that can be used to prevent canine C. perfringens infection.

2011-06-01·Pediatrics2区 · 医学

Immunogenicity and Safety of H influenzae Type b–N meningitidis C/Y Conjugate Vaccine in Infants

2区 · 医学

Article

作者: Bryant, Kristina A. ; Pavia-Ruiz, Noris ; Marchant, Colin D. ; Blatter, Mark ; Miller, Jacqueline M. ; Aris, Emmanuel ; Boutriau, Dominique ; Rinderknecht, Stephen ; Marshall, Gary S. ; Friedland, Leonard R. ; Nolan, Terry ; Lestrate, Pascal

BACKGROUND:Meningococcal disease incidence is highest in children younger than 2 years of age, yet there is no US-licensed vaccine for this age group. A phase III study evaluated the immunogenicity and safety of an investigational Haemophilus influenzae type b (Hib)–Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY).MATERIALS AND METHODS:A total of 4180 infants were randomly assigned to receive the HibMenCY at the ages of 2, 4, 6, and 12 to 15 months or the licensed Hib tetanus toxoid conjugate vaccine (ActHIB) at 2, 4, and 6 months and Hib conjugated to N meningitidis outer membrane protein (PedvaxHIB) at 12 to 15 months. Routinely scheduled vaccines were coadministered. Serum bactericidal activity using human complement and anti–polyribosylribitol phosphate antibodies were assessed in 991 subjects. Local and systemic adverse reactions were recorded for 4 days after each dose.RESULTS:The percentage of HibMenCY recipients with serum bactericidal assay using human complement titers of 1:8 or higher after dose 3 was 98.8% for N meningitidis serogroup C (MenC) and 95.8% for N meningitidis serogroup Y (MenY). After dose 4, the percentages were 98.5% and 98.8%, respectively. The percentage of HibMenCY recipients with postdose 3 anti-polyribosylribitol phosphate antibody levels of ≥1.0 μg/mL was noninferior to that of control (96.3% vs 91.2%). After dose 4, MenC and MenY serum bactericidal assay using human complement antibody titers increased 12-fold over pre–dose 4 levels. Incidence of pain, redness, and swelling at the HibMenCY injection sites tended to be lower than with Hib type b after the first 3 doses and after the fourth dose. Rates of systemic symptoms were similar across groups.CONCLUSIONS:The HibMenCY was immunogenic against MenC and MenY and induced anti–polyribosylribitol phosphate antibody levels noninferior to those of licensed Hib conjugate vaccine. The safety profile of the HibMenCY was clinically acceptable and comparable to Hib conjugate vaccine.

1998-02-01·Expert Opinion on Investigational Drugs2区 · 医学

Meningococcal vaccine development: a novel approach

2区 · 医学

Article

作者: Francis Michon ; Peter C Fusco ; Milan S Blake

Neisseria meningitidis is a major world-wide cause of meningitis. Effective capsular polysaccharide (CPS) vaccines that elicit CPS-specific bactericidal (BC) antibodies were previously developed and licensed to protect against meningococcal disease. However, due to their T-cell independent character, CPS vaccines are useless in infants and do not provide immunological memory or long-lasting protection in adults. CPS-protein conjugate vaccines are being developed to improve and broaden vaccine efficacy by creating T-cell dependent antigens. However, group B meningococci (GBM) are responsible for nearly half of meningococcal disease and possess a CPS, composed of polysialic acid, that is poorly immunogenic. N-propionyl (NPr) modification of the GBM polysaccharide (GBMP) has enhanced its immunogenicity, but BC antibodies are not induced at high levels, even when conjugated to conventional protein carriers, unless adjuvants stronger than aluminium hydroxide are used. We have chosen to couple the NPr-GBMP by reductive amination to a recombinant GBM class 3 porin (rPorB), which we have shown to modulate the immune response in animals towards the production of CPS-specific BC antibodies. We have also combined this conjugate with similar CPS-rPorB conjugates for groups A and C meningococci to form a trivalent A/B/C conjugate vaccine. This trivalent meningococcal vaccine has been shown to be safe and highly immunogenic in mice and non human primates, generating CPS-specific BC antibodies for each of the 3 major serogroups, which should provide world-wide protection against meningococcal disease.

100 项与 A群C群脑膜炎球菌结合疫苗（欧林生物）相关的药物交易

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