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 Original Articles |
| Safety and immunogenicity of a Inactivated Hemorrhagic Fever with Renal Syndrome Vaccine(Hantaan Virus Vaccine) in Children with Two Different Dose Regimen: Changes of Antibody Response after 3 Doses(0, 1, 13 months) Vaccination |
| Young Mo Soh, Kyung Hwan Oh, Chang Hwi Kim, Sang Mann Shin, Sang Jhoo Le, Young Bae Moon, Seok Yang, Mi Ran Kim, Dug Ha Kim, Hae Ran Lee, Chong Young Par |
| Department of Pediatrics, Yonsei University, College of Medicine, Department of Pediatrics, Soonchunhyang University, College of Medicine, Department of Pedia |
Vol.12 Num.2 (p138~144)
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Formalin inactivated Hantaan virus vaccine(HantavaxR) purified from sucking rat brains was demonstrated 97% of seroconversion rate and no significant side reaction in adult volunteers with standard dose of 0.5ml(10,249 ELISA unit/mL). There is no data in Children. We have recently compared results of the safety and immunogenicity of Hantaan virus vaccine in healthy children to investigate the seroconversion rate with half of recommended adult dose in standard vaccination schedule. Two hundred forty five children with age between four to eighteen were randomly assigned to two groups. Full dose group(FDG) (n=130, mean age 14 yrs) recieved 0.5ml (4,096 ELISA unit) of Hantavax and half dose group(HDG) (n=115, mean age 10 yrs) received 0.25ml (2,049 ELISA unit). Both group was vaccinated with three consecutive subcutaneous injections, according to 1 and 4 weeks vaccination schedule and following one booster injection at 13 months after first vaccination. Immunogenicity was assessed by determination of IgG antibody titers for vaccine antigens using immunofluorescent antibody technique in four different time period, prior to vaccination(To), 4 weeks after first dose(T1) and 4 weeks after second dose(Ts2), 12 months after second dost(T3) and 4 weeks after booster dost(T4). Reactogenicity was assessed by recording of local and general reactions for one week after administration of each dose. There were no sever general reaction during follow up, except minor adverse reactions which contained mild fever(3), swelling and redness(12) at the injection site in FDG and mild fever(2), dizziness(1), swelling and redness(10) in HDG.
The seroconversion rate and geometric mean titers(GMTs) between two groups were as follows; seroconversion rate of HDG was 95.0% and that of FDG was 99.1% at T2(P>0.1). The GMTs of HDG were 279.2 and that of FDG were 260.0 at T2(P>0.5). At twelve months after second dose(T3), the seropositive rate and GMTs were 36.5% and 51.2 in HDG and 41.8% and 45.2 in FGD. Booster dose enhanced the seropositive rate and GMTs to 97.4%, 288.3 in HDG and 98.7%, 323.4 in FDG at 4 weeks after third dose(T4) (P>0.5). We concluded that low dose administration of Hantaan virus vaccine, 0.25ml, subcutaneously may be optimum in efficacy for the immunization of children.
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