本文選題：麻疹-流行性腮腺炎-流行性乙型腦炎聯(lián)合減毒活疫苗 + 安全性評價�。� 參考：《中國疫苗和免疫》2014年06期

【摘要】：目的進行麻疹-流行性腮腺炎(流腮)-流行性乙型腦炎(乙腦)聯(lián)合減毒活疫苗(Measles,Mumps and Japanese Encephalitis Combined Attenuated Live Vaccine,M-M-JEV)的安全性評價。方法小鼠急性毒性試驗:設M-M-JEV擬用臨床劑量的80倍為低劑量,擬用臨床劑量的400倍為高劑量,1次皮下注射給藥,同時設陰性對照。觀察臨床癥狀,檢查注射部位、體重、病理學。猴體長期毒性試驗:設M-M-JEV擬用臨床劑量為低劑量,擬用臨床劑量的5倍為高劑量,2次皮下注射給藥,同時設陰性對照及麻疹減毒活疫苗、流腮減毒活疫苗和乙腦減毒活疫苗對照。觀察臨床癥狀,檢查注射部位、體溫、體重、心電圖、血液學、血清生物化學、攝食量、尿液、眼科學以及血清中和抗體(Neutralizing Antibody,NA)的變化情況,大體病理學和組織病理學檢查。結(jié)果各項觀察指標及檢查結(jié)果均與對照疫苗或陰性對照相似,相關(guān)數(shù)據(jù)與對照疫苗或陰性對照組比較差異無統(tǒng)計學意義,未見其他明顯毒副作用,第1次給藥后4周,麻疹病毒NA、流腮病毒NA及乙腦病毒NA水平與對照單價疫苗比較差異均無統(tǒng)計學意義。結(jié)論M-M-JEV表現(xiàn)出與單價疫苗相似的安全性和免疫原性。
[Abstract]:Objective to evaluate the safety of measles Mumps and Japanese Encephalitis combined Attenuated Live Vaccine M-M-JEV. Methods Acute toxicity test in mice: the clinical dose of M-M-JEV was 80 times as low as that of clinical dose, and the 400 times of clinical dose was high dose once subcutaneously, and the negative control group was set up at the same time. Clinical symptoms were observed, injection site, body weight and pathology were examined. The long-term toxicity test of monkey body: the clinical dose of M-M-JEV was low, the 5 times of clinical dose was high dose, and the negative control and live measles attenuated vaccine were set up. Gills attenuated live vaccine and Japanese encephalitis attenuated live vaccine control. The changes of clinical symptoms, body temperature, body weight, electrocardiogram, hematology, serum biochemistry, intake, urine, ophthalmology and serum neutralizing antibody (Neutralizing Antibody na) were observed. Results the observed indexes and examination results were similar to those of the control vaccine or the negative control group. There was no significant difference in the relative data between the control vaccine and the negative control group, and no other significant side effects were observed. Four weeks after the first administration of the drug, there was no significant difference between the two groups. There was no significant difference in na levels of measles virus, gills virus and Japanese encephalitis virus compared with control monovalent vaccine. Conclusion M-M-JEV shows similar safety and immunogenicity to monovalent vaccine.
【作者單位】： 武漢生物制品研究所有限責任公司 國家聯(lián)合疫苗工程技術(shù)研究中心;中國食品藥品檢定研究院;國家藥物安全評價監(jiān)測中心;
【基金】：國家高技術(shù)研究發(fā)展計劃(863計劃)重大項目生物和醫(yī)藥技術(shù)領(lǐng)域疫苗與抗體工程項目(編號2006AA02A233)
【分類號】：R392

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