Korean J Pediatr Infect Dis.  2001 Nov;8(2):160-167. 10.14776/kjpid.2001.8.2.160.

Immunogenicity and Safety of a Two Doses of Hepatitis A Vaccine(VAQTAâ„¢) in Healthy Children and Adolescents

• Lee JS
• Park JH
• Sohn YM

• KMID: 2440181
• DOI: http://doi.org/10.14776/kjpid.2001.8.2.160

Abstract

PURPOSE
To assess the immunogenicity, safety, and tolerability of hepatitis A vaccine (VAQTAâ„¢) in healthy children and adolescents.
METHODS
Eligible subjects aged 2 to 17 years received 25 U/0.5 mL of VAQTAâ„¢ intramuscularly at 0 and 24 week schedule. Bleeds were obtained prior to vaccination and 4 weeks after the second dose to ascertain serostatus. To detect antibody to HAV after vaccination with an inactivated HA vaccine, a modification of the Abbott® HAVAB kit was used. Sample with titers ≥ 10 mIU/mL were considered seroconverted. Adverse experiences were monitored.
RESULTS
102 subjects(54 male, 48 female) were enrolled. The mean age was 6.8±3.5 years. Two subjects were seropositive, two were lost of follow up. 88 subjects were available for a per protocol analysis and 90 for all subjects with serology after the second dose, and ten withdral. All subjects(95% CI, 94.8~100) seroconverted. Geometric mean titers was 7,991.1(95% CI, 6,481.1~9,852.7) with very little difference in per protocol analysis and all subjects analysis. Adverse experiences to VAQTAâ„¢ were generally mild and transient.
CONCLUSION
The pediatric two-dose regimen of VAQTAâ„¢ was found to be highly immunogenic, generally well tolerated and resulted in 100% seroconversion. Regarding Korea is in transition from a high to low risk region resulting in a paradox increase of clinical disease and disease burden, routine vaccination should be considered in order to control hepatitis A effectively.

Keyword

Hepatitis A; Epidemiology; Hepatitis A vaccine; Immunogenicity; Safety

MeSH Terms

Adolescent*
Appointments and Schedules
Child*
Epidemiology
Follow-Up Studies
Hepatitis A Vaccines
Hepatitis A*
Hepatitis*
Humans
Korea
Male
Seroconversion
Vaccination
Hepatitis A Vaccines

Figure

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  Fig. 1. Diagram for number of subjects.