title: Immunogenicity and safety of three consecutive lots of a new preservative-free inactivated hepatitis A vaccine (Healive): a double-blind, randomized and controlled trial.
abstract: Immunization is considered as the most effective way for the prophylaxis of hepatitis A virus (HAV) infection. This study aimed to evaluate the immunogenicity and safety of three consecutive lots of a new preservative-free inactivated hepatitis A vaccine (Healive) in healthy children. A double-blind, randomized and controlled clinical trial was conducted in healthy volunteers aged from 1 to 8 years. Total 400 subjects were enrolled and assigned into four groups, receiving one of the three lots of Healive or an established control vaccine. The vaccination was two-dose regimen with 6 months apart. Anti-HAV titers were determined at the 1st, 6th and 7th month. The results showed that Healive was highly immunogenic in children with 100% seroconversion rate (SR) and 3237-3814 mIU/ml geometry mean titer (GMT) 1 month after the second dose. The immunogenicity of Healive was statistically higher than that of the control vaccine with respect to GMT and SR (P=0.037 to P<0.001). Both Healive and control vaccine were well tolerated with 1-5% incidence of overall adverse reactions (P>0.298). Severe adverse reaction was not reported. Both SRs (1, 6 and 7 months) and GMTs (1 and 7 months) in subjects receiving one of the three consecutive lots of Healive had not statistical difference (P=0.114-0.710), suggesting that Healive was well consistent. The immune responses in younger children (1-3 years) and older children (4-8 years) were similar to each other (P=0.187-0.963). The present study indicated that Healive was greatly consistent between production lots, well tolerated and highly immunogenic in children, which made the preservative-free inactivated hepatitis A vaccine well suitable for inclusion in the routine programme of children vaccination.
authors.affiliation: Changzhou City Center for Diseases Control and Prevention, Changzhou 213003, Jiangsu Province, China.
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Jiang
authors.forename: Jiang-Ting
authors.initials: JT
authors.lastname: Chen
authors.forename: Xu
authors.initials: X
authors.lastname: Wang
authors.forename: Ya-Long
authors.initials: YL
authors.lastname: Wang
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.forename: Wen-Yu
authors.initials: WY
authors.lastname: Chen
authors.forename: Wen-Guo
authors.initials: WG
authors.lastname: Xu
authors.forename: Yuan-Zheng
authors.initials: YZ
authors.lastname: Qiu
authors.forename: Wei-Dong
authors.initials: WD
authors.lastname: Yin
mesh_terms: D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006506:Hepatitis A / Q000517:prevention & control; D035922:Hepatitis A Antibodies / Q000097:blood; D022362:Hepatitis A Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000592:standards; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology / Q000592:standards
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated