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项与 纯化乙型脑炎灭活疫苗(Vero细胞)(山东恒业生物) 相关的临床试验对6-11月龄健康婴幼儿进行的纯化乙型脑炎灭活疫苗(Vero细胞)单中心、随机、盲态、阳性对照Ⅲ期临床试验
评价山东恒业生物技术有限公司生产的纯化乙型脑炎灭活疫苗(Vero细胞)在6-11月龄常住健康婴幼儿中基础免疫的免疫原性和安全性。
A Single-centre Phase III Clinical Trial for Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Produced by Shandong Hengye Biotech Co., Ltd. in Healthy Chinese Infants Aged 6-11 Months, Aimed to Evaluate Immunogenicity and Safety
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.
An Open-label Phase 2a Clinical Trial to Test the Effect of Yellow Fever Vaccination in a Background of Japanese Encephalitis Antibodies.
Epidemic viral diseases have become more prevalent in recent years. Among the various strategies to prevent such epidemics, vaccination is the most cost-effective. However, populations that are immunized are typically already exposed to multiple previous vaccinations or natural infections. Studies from this and other laboratories have revealed that pre-existing dengue antibodies can either inhibit or enhance subsequent dengue infection depending on the pre-existing antibody levels. While cross-reactive antibody is potentially pathogenic in dengue, how it impacts immune response to vaccination is unclear. Indeed, aggregated at the site of vaccination and the respective draining lymph nodes are antigen-presenting and immune regulatory cells that express Fc receptors and play pivotal roles in determining the magnitude and polarity of the immune response. Vaccine uptake by these antigen-presenting cells may thus be either inhibited or enhanced when vaccines are opsonized with cross-reactive antibodies.
In view of the limited knowledge on how cross-reactive antibodies affect vaccination outcome, investigators propose here a study that exploits the known cross reactivity between Japanese encephalitis (JE) virus antibody and yellow fever (YF) vaccine. Investigators hypothesize that cross-reactive antibodies impacts antibody response to YF at the point vaccination in a concentration-dependent manner by altering both vaccine uptake and the innate immune response by antigen presenting cells. Investigators will structure an open label clinical trial on sequential vaccination with JE and YF vaccines, with different time intervals between vaccinations. This would test immune response to YF vaccination in subjects with different titer of cross-reactive JE vaccine-derived antibodies.
100 项与 纯化乙型脑炎灭活疫苗(Vero细胞)(山东恒业生物) 相关的临床结果
100 项与 纯化乙型脑炎灭活疫苗(Vero细胞)(山东恒业生物) 相关的转化医学
100 项与 纯化乙型脑炎灭活疫苗(Vero细胞)(山东恒业生物) 相关的专利(医药)
100 项与 纯化乙型脑炎灭活疫苗(Vero细胞)(山东恒业生物) 相关的药物交易