Immunogenicity and Safety of an F-Genotype Attenuated Mumps Vaccine in Healthy 8- to 24-Month-Old Children. (1st August 2018)

• Record Type: Journal Article
• Authors: Liang, Yan; Che, Yanchun; Yang, Beifang; Zhan, Faxian; Li, Hong; Guan, Xuhua; Zhang, Ying; Yin, Qiongzhou; Li, Changgui; Li, Jing; Zhao, Zhimei; Liu, Longding; Jiang, Guorun; Liao, Yun; Xu, Xingli; Ye, Jianjun; Ren, Qunhui; He, Yonghua; Feng, Min; Wang, Lichun; Fan, Shengtao; Cui, Xiaoyu; Wang, Zhao; Li, Chuanyin; Xiao, Haitao; Liu, Rong; Li, Qiong; Jiang, Changjun; Liu, Jianqun; Li, Qihan
• Is Part Of: Journal of infectious diseases. Volume 219:Number 1(2019)
• Page Start: 50
• Page End: 58
• Publication Date: 2018-08-01
• Subjects: attenuated mumps vaccine -- F-genotype -- noninferiority; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiy469
• Languages: English
• ISSNs: 0022-1899

Abstract

Abstract: Background: Mumps vaccine immunizations have reduced the incidence of this disease. With the variation of mumps circulating strain, novel vaccine strains are always important. Methods: A 2-center parallel, randomized, double-blind noninferiority trial was performed to compare an F-genotype attenuated mumps vaccine (SP strain) to the A-genotype vaccine (S-79, Jeryl-Lynn strain) in 1080 healthy children aged 8–24 months in Hubei, China. Results: Participants were randomly assigned to receive a high or low dose of the SP or S79 vaccine and then assessed clinically at 30 minutes and 1–28 days postinoculation. No differences in local or systemic reactivity were observed. A similar incidence of severe adverse events associated with the vaccine was observed in the high-dose group and the positive control group. Based on throat swab collections, no viral shedding was present at the 4th and 10th days in any group. Neutralizing and hemagglutination-inhibiting antibody assays with the F- or A-genotype strains showed similar trends in geometric mean titers in the high-dose SP and S79 groups. Increased cytotoxic T lymphocyte responses were observed in all groups. Conclusions: The F-genotype attenuated mumps vaccine is safe, offers immunogenicity against a homologous virus, and is noninferior to the A-genotype vaccine in 8- to 24-month-old children. Abstract : The phase II trial of a novel F-genotype attenuated mumps vaccine made with a circulating strain in healthy children 8 to 24 months of age shows safety, good immunogenicity, and noninferiority to the current A-genotype vaccine.