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신생아에 대한 가열 비 활동화한 B형 간염백신의 안전성과 면역성에 대한 임상적 관찰
전정식,이익준,심규식,정승연,정진우,최규용,조규홍,강진환,김승조,선희식,성인경,정규원,정환국,김부성 대한감염학회 1987 감염 Vol.19 No.4
A new heat-inactivated HBV vaccine has been evaluated for safety and immunogenicity in 157 newborn recipients. Three(Group 3M), one and a half(Group 1.5M), and one(Group 1M) μgm(HBsAgprotein) doses were given at 0,1 and 2 months.Three(Group 3W) and(Group 1W) μgm doses were also given at 0,1 and 2 weeks. All vaccine was administered intramuscularly in the thigh muscle. An adequate follow-up observation was possible during the period of 6 months after birth in 33, 26, 28, 34 and 36 infants in Groups 3M, 1.5M, 1M, 3W and 1W, respectively. Side effects were minor with limited local reaction at the site of adminisration. The 3W group produced seroconversion earliest and most rapidly, showing the highest rate of 60% and 70% at 1 and 2 months of age, resectively. However, at the age of 3 months, the highest seroconversion rate of 91.7% was observed in Group 1.5M, followed by 84.6% in Group 3W, 66.7% in Group 3M, 61.5% in Group 1M and 57.1% in Group 1W. At the age of 6 months, 87.5% of Group 3W, 80.8% of Group 1M, 80.4% of Group 1.5M, 83.3% of Group 3M infants showed seroconversion. However, a drop to 44.4% seroconversion was seen in Group 1W. There was no significant differences in seroconversion rates between Groups 3W, 1M, 1.5M and 3M at 6 months of age. There was also very little difference between these 4 Group regarding to the value of antibody response in terms of geometric mean titer. The vaccine was found to be safe and highly immunogenic for newborn infants. It can be concluded that 1.5M schedule is optimum for the immunization of newborn infants in immunogenicity and economy, while the 3W schedule can induce the earliest and most rapid seroconversion.