건강한 한국 소아에서 HM175주 A형 간염 불활화 백신의 면역원성 및 이상반응에 관한 연구 = Immunogenicity and Reactogenicity of Inactivated HM175 Strain Hepatitis A Vaccine in Healthy Korean Children

다국어 초록 (Multilingual Abstract)

Purpose : Active immunization against hepatitis A with an inactivated vaccine reveals excellent immunogenicity, tolerability and protective efficacy. Inactivated hepatitis A vaccines have been selectively used since 1996 in Korea to prevent hepatitis A. This study was performed to assess the immunogenicity and reactogenicity after two doses of HM175 strain hepatitis A vaccine in healthy Korean children. Methods : 128 healthy children(M/F; 65/63) aged 1 to 15 years, who were seronegative for hepaitatis A, participated in this study. A alum-adsorbed vaccine containing 720 EL.U of antigen form HM175 hepatitis A strain per 0.5 mL dose was injected intramuscularly on the deltoid area. The second dose was given 6 months later, Anti-HAV antibodies were measured by ELISA before and 1 month after each vaccination to assess the immunogenicity. Any local and general adverse events were reported by patients parents with the prepared questionnaire after each vaccination. Results : 120 volunteers(M/F; 60/60) completed the whole series of the study. Seroconversion occurred in all cases after primary and booster vaccination. The mean anti-HAV antibody titer after primary vaccination was 389.2mIU/mL, and 3,609mIU/mL after booster vaccination. And levels of anti-HAV antibodies after booster immunization were significantly higher in female children. The most common local adverse event was soreness on the injection site, but it was mild and resolves within 3 days. Fever was not reported after booster vaccination. Conclusion : Based on these data, we conclude that the inactivated HM175 strain hepatitis A vaccine is highly immunogenic and tolerable in healthy Korean children.