title: Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents.
abstract: Although the overall incidence of hepatitis A in Korea has been decreasing, adolescents remain highly vulnerable to its outbreaks. This study was conducted to compare the immunogenicity and safety of three hepatitis A vaccines in Korean adolescents. Healthy anti-hepatitis A virus seronegative subjects aged 13 to 19 yr were randomized in three equal groups to receive two doses of Avaxim™, Epaxal®, or Havrix®, 6 to 12 months apart. Seroconversion rates one month after the first dose were 98%, 95%, and 93% for Avaxim™, Epaxal®, and Havrix®, respectively. Seroconversion rates reached 100% for all vaccine groups one month after the second dose. Anti-HAV geometric mean concentrations (GMCs) were 7,207.7 mIU/mL (95% CI, 6023.1-8684.7), 1,750.5 mIU/mL (95% CI, 1362.9-2248.3), and 1,953.5 mIU/mL (95% CI, 1459.4-2614.7) after two doses of Avaxim™, Epaxal®, and Havrix® respectively. Avaxim™ was significantly more immunogenic than Epaxal® and Havrix®, whereas there were no significant differences in antibody responses between Epaxal® and Havrix®. Local and systemic solicited adverse events (AEs) were mostly of mild-to-moderate intensity and resolved within 5 days. No serious AEs were reported. In conclusion, all three vaccines are highly immunogenic and well-tolerated in Korean adolescents. (Clinical Trial Registry NCT00483470).
authors.affiliation: Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Korea.; Center for Vaccine Evaluation and Study, Medical Research Institute, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Seo Hee
authors.identifier: 0000-0002-8361-9815
authors.initials: SH
authors.lastname: Yoon
authors.affiliation: Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Korea.; Center for Vaccine Evaluation and Study, Medical Research Institute, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Han Wool
authors.identifier: 0000-0003-3463-3060
authors.initials: HW
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Korea.; Center for Vaccine Evaluation and Study, Medical Research Institute, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Jong Gyun
authors.identifier: 0000-0001-5748-0015
authors.initials: JG
authors.lastname: Ahn
authors.affiliation: Seegene Medical Foundation, Seoul, Korea.
authors.forename: In Tae
authors.identifier: 0000-0002-2322-3018
authors.initials: IT
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
authors.forename: Jong-Hyun
authors.identifier: 0000-0001-8641-7904
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Ewha Womans University Mokdong Hospital, Seoul, Korea.
authors.forename: Kyoung Ae
authors.identifier: 0000-0003-1658-3282
authors.initials: KA
authors.lastname: Kong
authors.affiliation: Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Korea.; Center for Vaccine Evaluation and Study, Medical Research Institute, School of Medicine, Ewha Womans University, Seoul, Korea.
authors.forename: Kyung-Hyo
authors.identifier: 0000-0002-0333-6808
authors.initials: KH
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000917:Antibody Formation; D005260:Female; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control*; D035922:Hepatitis A Antibodies / Q000097:blood; D022362:Hepatitis A Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D008297:Male; D056910:Republic of Korea; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated
keywords: Adolescent; Antibody Formation; Hepatitis A Vaccines; Safety