J Korean Med Sci.  2016 Jan;31(1):73-79. 10.3346/jkms.2016.31.1.73.

Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents

• Yoon SH
• Kim HW
• Ahn JG
• Kim IT
• Kim JH
• Kong KA
• Kim KH

• KMID: 2359995
• DOI: http://doi.org/10.3346/jkms.2016.31.1.73

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(TM), Epaxal(R), or Havrix(R), 6 to 12 months apart. Seroconversion rates one month after the first dose were 98%, 95%, and 93% for Avaxim(TM), Epaxal(R), and Havrix(R), 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(TM), Epaxal(R), and Havrix(R) respectively. Avaxim(TM) was significantly more immunogenic than Epaxal(R) and Havrix(R), whereas there were no significant differences in antibody responses between Epaxal(R) and Havrix(R). 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)

Keyword

Hepatitis A Vaccines; Antibody Formation; Safety; Adolescent

MeSH Terms

Adolescent
Antibody Formation
Female
Hepatitis A/immunology/*prevention & control
Hepatitis A Antibodies/blood
Hepatitis A Vaccines/adverse effects/*immunology
Humans
Male
Republic of Korea
Vaccines, Inactivated/adverse effects/immunology
Young Adult
Hepatitis A Antibodies
Hepatitis A Vaccines
Vaccines, Inactivated

Figure

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  Fig. 1 Study design and disposition of subjects. *Subjects were excluded due to ineligibility for the study. ITT, intention-to-treat; PP, per-protocol; P, pediatric dose; A, adult dose.

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  Fig. 2 Comparison of the immunogenicity of the three hepatitis A vaccines at each visit. (A) Comparison among the Vaccine A, Vaccine B, and Vaccine C groups. (B) Comparison among the subgroups with three pediatric doses of each vaccine. (C) Comparison between the subgroups with two adult doses of each vaccine. Visit 1, at enrollment; visit 2, one month after the first dose; visit 3, just prior to the second dose (6 to 12 months after the first dose); visit 4, one month following the second dose.

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  Fig. 3 Reverse cumulative distribution curves of the anti-HAV antibody concentrations for the three vaccine groups at each visit. Vertical solid line, cut-off value for anti-HAV seroprotection, 20 mIU/mL.

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