title: Comparison of the safety and immunogenicity of live attenuated and inactivated hepatitis A vaccine in healthy Chinese children aged 18 months to 16 years: results from a randomized, parallel controlled, phase IV study.
abstract: For large-scale immunization of children with hepatitis A (HA) vaccines in China, accurately designed studies comparing the safety and immunogenicity of the live attenuated HA vaccine (HA-L) and inactivated HA vaccine (HA-I) are necessary. A randomized, parallel controlled, phase IV clinical trial was conducted with 6000 healthy children aged 18 months to 16 years. HA-L or HA-I was administered at a ratio of 1: 1 to randomized selected participants. The safety and immunogenicity were evaluated. Both HA-L and HA-I were well tolerated by all participants. The immunogenicity results showed that the seroconversion rates (HA-L versus HA-I: 98.0% versus 100%, respectively, p >0.05), and geometric mean concentrations in participants negative for antibodies against HA virus IgG (anti-HAV IgG) before vaccination did not differ significantly between the two types of vaccines (HA-L versus HA-I first dose: 898.9 versus 886.2 mIU/mL, respectively, p >0.05). After administration of the booster dose of HA-I, the geometric mean concentrations of anti-HAV IgG (HA-I booster dose: 2591.2 mIU/mL) was higher than that after the first dose (p <0.05) and that reported in participants administered HA-L (p <0.05). Additionally, 12 (25%) of the 48 randomized selected participants who received HA-L tested positive for HA antigen in stool samples. Hence, both HA-L and HA-I could provide acceptable immunogenicity in children. The effects of long-term immunogenicity after natural exposure to wild-type HA virus and the possibility of mutational shifts of the live vaccine virus in the field need to be studied in more detail.
authors.affiliation: Jiangsu Provincial Centre of Disease Control and Prevention, Nanjing, Jiangsu Province, China.
authors.forename: F
authors.initials: F
authors.lastname: Ma
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences, Kunming, Yunnan Province, China.
authors.forename: J
authors.initials: J
authors.lastname: Yang
authors.affiliation: Jiangsu Provincial Centre of Disease Control and Prevention, Nanjing, Jiangsu Province, China. Electronic address: jsepi@vip.sina.com.
authors.forename: G
authors.initials: G
authors.lastname: Kang
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences, Kunming, Yunnan Province, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Sun
authors.affiliation: Jiangsu Provincial Centre of Disease Control and Prevention, Nanjing, Jiangsu Province, China.
authors.forename: P
authors.initials: P
authors.lastname: Lu
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences, Kunming, Yunnan Province, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Jiangsu Provincial Centre of Disease Control and Prevention, Nanjing, Jiangsu Province, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Wang
authors.affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences, Kunming, Yunnan Province, China.
authors.forename: J
authors.initials: J
authors.lastname: Luo
authors.affiliation: Xiangshui County Centre of Disease Control and Prevention, Jiangsu Province, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002681:China; D005260:Female; D064368:Healthy Volunteers; D006506:Hepatitis A / Q000517:prevention & control*; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D030041:Hepatitis A virus / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007074:Immunoglobulin G / Q000276:immunology; D007223:Infant; D008297:Male; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D007074:Immunoglobulin G; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated
keywords: Children; Hepatitis A; Immunogenicity; Safety; Vaccine