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Comparison of the immunogenicity and safety of 3 inactivated hepatitis A vaccines in Korean children aged 12 to 18 months: An open-label, randomized, prospective, multicenter study

Title
Comparison of the immunogenicity and safety of 3 inactivated hepatitis A vaccines in Korean children aged 12 to 18 months: An open-label, randomized, prospective, multicenter study
Authors
Hong, Seung SooChoi, Ui YoonMa, Sang HyukLee, Soo YoungHan, Seung BeomKim, Kyung-HyoKang, Jin HanKim, Jong-Hyun
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2019
Journal Title
MEDICINE
ISSN
0025-7974JCR Link

1536-5964JCR Link
Citation
MEDICINE vol. 98, no. 6
Keywords
childcomparisonhepatitis A vaccineimmunogenicitysafety
Publisher
LIPPINCOTT WILLIAMS &

WILKINS
Indexed
SCI; SCIE; SCOPUS WOS scopus
Document Type
Article
Abstract
Several approved inactivated hepatitis A (HA) vaccines are available in Korea. These have been shown to be immunogenic and safe in European children; however, their immunogenicity and safety have not been investigated among Korean children. We aimed to compare the immunogenicity and safety of the most commonly used HA vaccines in ethnic Korean children aged 12 to 18 months.In this open-label, randomized, prospective, multicenter study, 108 children were enrolled and randomized to receive a pediatric form of Avaxim, Epaxal, or Havrix. The 2nd dose was administered after an interval of 6 months. Anti-HA virus (HAV) immunoglobulin (Ig) G was measured to assess geometric mean concentrations (GMCs) and seropositvity rates (20mIU/mL anti-HAV IgG). To assess safety, local solicited adverse events (AEs), systemic solicited AEs, unsolicited AEs, and serious AEs (SAEs) were graded.Among the 108 participants enrolled, 37, 34, and 37 received Avaxim, Epaxal, and Havrix, respectively. After administration of 2 doses, the seropositivity rates in the Avaxim, Epaxal, and Havrix groups were all 100% (95% confidence intervals [CIs]: 99.0-100, 98.9-100, and 99.0-100, respectively; P<.001). The anti-HAV GMCs in the Avaxim, Epaxal, and Havrix groups were 5868.4 (95% CI: 4237.2-8126.6), 1962.1 (95% CI: 1298.0-2965.9), and 2232.9mIU/mL (95% CI: 1428.4-3490.4), respectively, after administration of 2 doses (P<.001). There were no significant differences in the proportions of participants reporting local solicited AEs, systemic solicited AEs, unsolicited AEs, and SAEs among the 3 vaccine groups after the 1st and 2nd doses. All local solicited and unsolicited AEs were grade 1 or 2. Grade 3 systemic solicited AE occurred in 5.4% and 2.9% of the participants in the Havrix group after the 1st and 2nd doses, respectively. SAEs after the 1st and 2nd doses were reported in 2 participants and 1 participant, respectively, but none was assessed as being related to vaccination.The results indicate that these vaccines were safe and immunogenic in ethnic Korean children. The results have contributed to the establishing of an HA vaccination policy in Korea and will be informative to countries that plan to initiate vaccination programs against HAV.
DOI
10.1097/MD.0000000000014364
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의과대학 > 의학과 > Journal papers
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