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Safety and immunogenicity of a live attenuated mumps vaccine A phase I clinical trial 期刊论文

编号：

79f5daa4-21b1-4b89-874a-8befe84cf106
作者：

Liang, Yan^[1];Ma, Jingchen^[2];Li, Changgui^[3];Chen, Yuguo^[2];Liu, Longding^[1];Liao, Yun^[1];Zhang, Ying^[1];Jiang, Li^[1];Wang, Xuanyi(汪萱怡)^[4]Che, Yanchun^[1];Deng, Wei^[4];Li, Hong^[3];Cui, Xiaoyu^[3];Ma, Na^[1];Ding, Dong^[1];Xie, Zhongping^[1];Cui, Pingfang^[1];Ji, Qiuyan^[1];Wang, JingJing^[1];Zhao, Yuliang^[2];Wang, Junzhi^[3];Li, Qihan^[1];
语种：

English
期刊：

HUMAN VACCINES & IMMUNOTHERAPEUTICS ISSN：2164-5515 2014 年 10 卷 5 期 (1382 - 1390) ; MAY
收录：
关键词：

F genotype attenuated mumps vaccine Phase I clinical trial safety immunogenicity
摘要：

Background: Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas. Methods: A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16-60 years, 5-16 years, 2-5 years and 8-24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 +/- 0.25 logCCID(50)), B (4.25 +/- 0.25 logCCID(50)) and C (5.0 +/- 0.25 logCCID(50)), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls. Results: The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group. Conclusions: The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.
推荐引用方式
GB/T 7714：

Liang Yan,Ma Jingchen,Li Changgui, et al. Safety and immunogenicity of a live attenuated mumps vaccine A phase I clinical trial [J].HUMAN VACCINES & IMMUNOTHERAPEUTICS,2014,10(5):1382-1390.
APA：

Liang Yan,Ma Jingchen,Li Changgui,Chen Yuguo,&Li Qihan.(2014).Safety and immunogenicity of a live attenuated mumps vaccine A phase I clinical trial .HUMAN VACCINES & IMMUNOTHERAPEUTICS,10(5):1382-1390.
MLA：

Liang Yan, et al. "Safety and immunogenicity of a live attenuated mumps vaccine A phase I clinical trial" .HUMAN VACCINES & IMMUNOTHERAPEUTICS 10,5(2014):1382-1390.

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