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KMID : 0382619900100010619
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Hanyang Journal of Medicine
1990 Volume.10 No. 1 p.619 ~ p.625
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Immunogenicity of New Heat-Inactivated Hepatitis B Vaccine with Reduced Bose in Newborn Infants
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김용주/Kim, Yong Joo
김도현/오성희/신재훈/문수지/이근수/Kim, Do Hyun/Oh, Sung Hee/Shin, Jae Hoon/Moon, Soo Jee/Lee, Keun Soo
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Abstract
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94 newborn infants were enrolled in the study to compare the antibody response to two immunization schedules, differing only on the first dose, using new heat-inactivated plasma-derived hepatitis B virus(HBV) vaccine. Initial 3.0㎍ and two 1.5㎍ doses were given to infants born to HBsAg(-), anti-HBs(-) mothers(Group A) and those born to HBsAg(-), anti-HBs(+) mothers(Group B) at 0, 1 and 2 month after birth as for primary immunization. Three 1.5㎍ doses were given at the same time to infants born to HBsAg(-) mothers (Group A´) and those born to HBsAg(-), anti-HBs(+) mothers (Group B´). Additional 1.5㎍ vaccine was given at 14 months of age to infants in Group A and A´ who failed to become seroconverted. All vaccines were administered intramuscularly in the gluteal area. Blood was obtained at 2, 4, 6 and 9-14 months of age from all 4 groups and 15-18 months of age from infants who received booster vaccine dose in Group A and A´.
Side effects of vaccine were minor with limited local reactions at the site of injection. During the study period, no infants in 4 groups became positive for HBsAg or anti-HBc.
The anti-HBs and/or anti-preS₂seroconversion rates of group A, B, A´and B´at 9-14 months of age were 82%, 100%, 87% and 96%, respectively. One to two months after 1.5㎍ booster injection for non-seroconverted infants in group A and A´, the cumulative seroconversion rates of anti-HBs and/or anti-preS2 at 15-18 months were 86% and 91%, respectively.
Geometric mean titer of anti-HBs up to 6 months of age also showed little differences among 4 groups.
These data indicate that the higher initial dose (3㎍) does not give rise to greater immunogenicity and agree with the results reported by other investigators suggesting three 1.5㎍ dose schedule is comparable to 3.0㎍ dose schedule. Therefore when immunogenicity and economy are considered, three 1.5㎍ dose schedule would be the optimum for the primary immunization for newborn infants.
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