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 Original Articles |
| Studies on the Safety and Immunogenicity of Heat-Inactivated HB Vaccine in Children |
| Sun Hee Kim, Jung Kyung Kim, Byung Rai Cho , Myung Ik Lee, Keun Chan Sohn |
| Department of Pediatrics, National Medical Center, Seoul, Korea |
Vol.18 Num.1 (p69~74)
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A different type of hepatitis B vaccine was prepared by purification of HBsAg from a pool of plasma containing surface antigen. After purification, the HBsAg was inactivated by double-heat treatment, 2 minutes 40 secs at 102℃ and 10 hours at 65℃. The heat-inactivated HBsAg was absorbed to aluminum phosphate.
One dose of vaccine containing 3ug HBsAg absorbed to 0.6mg AIPO4. The final product met the guideline recommended by WHO and KNIH (Korean National Institute of Health). After establishing the safety and immunogenicity of vaccine in chimpanzee and human volunteers, fifty children were administered at the intervals of one month with three intramuscular injections of a dose of vaccine containing 1.5ug or 3ug of HBsAg.
Thirty five out of thirty seven children injected by a dose of vaccine containing 1.5ug of HBsAg and twelve out of thirteen children injected by a dose of vaccine containing 3ug of HBsAg have formed anti-HBs in two months after last vaccination.
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