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Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.

ABSTRACT: Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas.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.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.The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.

SUBMITTER: Liang Y

PROVIDER: S-EPMC4896512 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.

Liang Yan Y Ma Jingchen J Li Changgui C Chen Yuguo Y Liu Longding L Liao Yun Y Zhang Ying Y Jiang Li L Wang Xuan-Yi XY Che Yanchun Y Deng Wei W Li Hong H Cui Xiaoyu X Ma Na N Ding Dong D Xie Zhongping Z Cui Pingfang P Ji Qiuyan Q Wang JingJing J Zhao Yuliang Y Wang Junzhi J Li Qihan Q

Human vaccines & immunotherapeutics 20140310 5

<h4>Background</h4>Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas.<h4>Methods</h4>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 ...[more]

PMID: 24614759

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Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.

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Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.

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