title: Field performance of VAQTA (inactivated, purified hepatitis a vaccine) in Chinese children in Jiangsu.
abstract: In Jiangsu, 30% of children between the ages of 5 and 8 years test seropositive for hepatitis A. The safety, tolerability, and immunogenicity of a 2-dose regimen (0, 6 months) of VAQTA (0.5 ml of 25U) administered IM in 50 healthy children aged 5 to 8 years without prior serological screening was evaluated. Blood samples were collected prior to the first dose and after each additional dose of VAQTA to determine the initial anti-HAV serostatus and response rates to the vaccine. Twelve children (24%) were initially seropositive and 38 (76%) were initially seronegative. Four weeks after the primary dose of VAQTA, 34 of the 38 subjects (89.5%, 95% CI 75 to 97) were anti-HAV seropositive. The geometric mean titer was 33.1 mIU/ml (95% CI 22.4 to 49.0). After the booster dose at 6 months, all the subjects were seropositive (37/37), giving a seroconversion of 100% (95% CI: 90, 100). The geometric mean titer was 7585.8 mIU/ml (95% CI: 5623.4 to 10,471.3). Adverse experiences were generally mild and transient. Results of this study are consistent with results from a previous double-blind randomized trial of this vaccine and confirm that VAQTA is highly immunogenic, and generally well-tolerated.
authors.affiliation: Jiangsu Center of Disease Control, Jiangsu, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Wang
authors.forename: X
authors.initials: X
authors.lastname: Chen
authors.forename: Zhixian
authors.initials: Z
authors.lastname: Chen
authors.forename: W
authors.initials: W
authors.lastname: Lu
authors.forename: Gabriele
authors.initials: G
authors.lastname: Poerschke
authors.forename: Karen
authors.initials: K
authors.lastname: Eves
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Gress
authors.forename: Barbara
authors.initials: B
authors.lastname: Kuter
mesh_terms: D002648:Child; D002675:Child, Preschool; D002681:China; D005260:Female; D006506:Hepatitis A / Q000097:blood / Q000276:immunology*; D022362:Hepatitis A Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D008297:Male
chemical_list: D022362:Hepatitis A Vaccines