title: Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.
abstract: 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 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), 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.
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liang
authors.affiliation: Hebei province Center for Disease Control and Prevention; Shijiazhuang, PR China.
authors.forename: Jingchen
authors.initials: J
authors.lastname: Ma
authors.affiliation: National Institutes for Food and Drug Control; Beijing, PR China.
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.affiliation: Institute of Biological Sciences; Fudan University; Shanghai, PR China.
authors.forename: Yuguo
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Longding
authors.initials: L
authors.lastname: Liu
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Liao
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Li
authors.initials: L
authors.lastname: Jiang
authors.affiliation: Institute of Biological Sciences; Fudan University; Shanghai, PR China.
authors.forename: Xuan-Yi
authors.initials: XY
authors.lastname: Wang
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Yanchun
authors.initials: Y
authors.lastname: Che
authors.affiliation: Institute of Biological Sciences; Fudan University; Shanghai, PR China.
authors.forename: Wei
authors.initials: W
authors.lastname: Deng
authors.affiliation: National Institutes for Food and Drug Control; Beijing, PR China.
authors.forename: Hong
authors.initials: H
authors.lastname: Li
authors.affiliation: National Institutes for Food and Drug Control; Beijing, PR China.
authors.forename: Xiaoyu
authors.initials: X
authors.lastname: Cui
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Na
authors.initials: N
authors.lastname: Ma
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Dong
authors.initials: D
authors.lastname: Ding
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Zhongping
authors.initials: Z
authors.lastname: Xie
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Pingfang
authors.initials: P
authors.lastname: Cui
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Qiuyan
authors.initials: Q
authors.lastname: Ji
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: JingJing
authors.initials: J
authors.lastname: Wang
authors.affiliation: Hebei province Center for Disease Control and Prevention; Shijiazhuang, PR China.
authors.forename: Yuliang
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: National Institutes for Food and Drug Control; Beijing, PR China.
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
authors.affiliation: Institute Of Medical Biology; Chinese Academy of Medicine Science; Peking Union Medical College; Kunming, PR China.
authors.forename: Qihan
authors.initials: Q
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000139:chemically induced / Q000276:immunology; D005260:Female; D006801:Humans; D055261:Immunogenetic Phenomena / Q000187:drug effects / Q000276:immunology*; D007223:Infant; D008297:Male; D008875:Middle Aged; D009107:Mumps / Q000276:immunology* / Q000517:prevention & control*; D009108:Mumps Vaccine / Q000009:adverse effects* / Q000276:immunology*; D016037:Single-Blind Method; D017201:Virus Shedding / Q000187:drug effects / Q000276:immunology; D055815:Young Adult
chemical_list: D009108:Mumps Vaccine
keywords: F genotype attenuated mumps vaccine; Phase I clinical trial; immunogenicity; safety