Immunogenicity and saf ety of recombinant hepatitis B vaccine ( HG- II) in healthy adults according to months v accination s chedule

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1 : B (HG- II) : , *, * = A bs tra c t= Immunogenicity and saf ety of recombinant hepatitis B vaccine ( HG- II) in healthy adults according to months v accination s chedule Ok Jae Lee, M.D., Sun Mee Park, M.D.*, Joung Il Lee, M.D. Seok Ho Dong, M.D., Sung Won Cho, M.D.and Young Soo Kim, M.D. Department of Internal M edicine, Gyeongsang N ational University College of M edicine, Chinju, Department of Internal M edicine, Chungbuk N ational University College of M edicine, Chongju,* Department of Internal M edicine, K yunghee University College of M edicine, Seoul and Department of Internal M edicine, A jou University College of M edicine, Suwon,K orea Backg round : Green Cross HG- II vaccine is recombinant hepatitis B vaccine derived from yeast H ansenula polymorpha. Its immunogenicity and safety using months vaccination schedule were proven. This prospective study is conducted to evaluate immunogenicity and safety of HG-II according to months schedule. Methods : 20 g of HG- II vaccine was given intramuscularly at 0, 1, and 2 months to 118 healthy adults seronegative for hepatitis B markers. Sera were assessed for anti- HBs by radioimmunoassay at 1 months and 7-10 months after completion of vaccination. Results : 113 of 118 (95.8%) completed vaccination schedules. The seroconversion rate at 1 month after completion of vaccination was 93.8% (106/ 113) and protective titers of anti- HBs developed in 82.3% (93/ 113). The geometric mean titer (GMT ) of anti- HBs was miu/ml in all seroconverted vaccinee. There was no incapacitating serious side effect associated with vaccinations. T he seropositive rate at 7-10 months after vaccination was 95.3% (81/85) with protective rate of 84.7% (72/ 85). The anti- HBs titers were decreased in 51.8% (44/85) of vaccinee. T he GMT was miu/ml. T he protective rate and GMT were 98.0%, miu/ml in the group with anti- HBs titer 50 miu/ml at 1 month after vaccination, and 64.71%, miu/ml in the group with anti- HBs < 50 miu/ ml. Conclusion : Green Cross HG- II vaccine is safe and effective in protecting hepatitis B at months vaccination schedule. However, the booster injection should be recommended for maintenance : : :. 90, ( ) ojlee@nongae.gsnu.ac.kr ()

2 Ok Jae Lee, et al : Immunogenicity and safety of recombinant hepatitis B vaccine (HG- II) in healthy adults according to months vaccination schedule of immunogenicity, especially in the vaccinee with anti- HBs titer less than 50 miu/ ml at 1 month after vaccination.(korean J Med 58:12-18, 2000) Key Words : Recombinant hepatitis B vaccine, months schedule, Safety, Immunogenicity HG- II B H ansenula polymorpha, 2 Saccharomyces cerevisiae plasmid 1-3)., 0, 1, 6 4). HG- II0, 1, 2. 1., AST, ALT, - GT, HBsAg, anti- HBs anti- HBc.,,,.. 2. HG- II B ml(20 g)1 3, 3 1 anti- HBs. 3 miu/ml, 10 miu/ml anti- HBs. B Abbott AUSRIA II- 125, AUSAB, CORAB. 72,,,,,. T able % , (21-63) 30.3, Table 1. Ag e and sex distribution of subjects Sex No. of cases Age(years) Male Female T otal range mean T otal

3 : Table 2. Seroconversion rates and geometric mean titers for anti- HBs after completion of HG- II vaccination Age (years) Seroconversion rate(%) GMT (miu/ ml) M F T M F T /25(100) 39/39(100) 64/64(100) * /11(72.7) 22/24(91.7) 30/35(85.7) /2 (50.0) 6/7(85.7) 7/9(77.8) /2(100) 2/2(100) /2 (100) 1/1(100) 3/3(100) /15(73.3) 31/34(91.2) 42/49(85.7) * T otal 36/40(90.0) 70/73(95.9) 106/113(93.8) GMT, geometric mean titer; M, male; F, female; T, total * significant difference betw een tw o age groups (p< 0.05) significant difference betw een male and female groups (p< 0.05), 3, 2,. 1. Anti-HBs T able anti- HBs 93.8%., %, %, (90.0%), 73 70(95.9%). Figure 1. Geometric mean titers of anti- HBs after HG- II vaccination. (p< 0.05). T able 2 Figure 1, miu/ml, miu/ml, miu/ml, miu/ml, miu/ml miu/ml, miu/ml30 (p<0.05). 2. 1) 1 (1 ) (82.3%) 10 miu/ml anti- HBs, 54 (47.8%) 50 miu/ml. 106 T able miu/ml, miu/ml, miu/ml 2) 7-10 (2 ) , 62, (95.3%)3 miu/ml, 10 miu/ml % % T able 3Figure

4 5: B (HG- II) : Table 3. Geometric mean titers for anti- HBs 1 month and 7-10 months after completion of HG- II vaccination T ime after completion GMT of vaccination M F T 1 month months Fig ure 2. Geometric mean titers of anti- HBs at 1 month and 7-10 months after completion of vaccination. 3 miu/ml miu/ml miu/ml miu/ml, miu/ml, 1, miu/ml, miu/ml (p<0.05) miu/ml 5, 1 50 miu/ml anti- HBs 50 miu/ml, 50 miu/ml 5150 (98.0%), miu/ml, 50 miu/ml 34 22(64.71%), miu/ml miu/ml, Figure 3 (p<0.05). 3. T able 4 HG- II 1 118, 2114, %., Table 4. Side effects after each vaccination of HG- II Side effects 1st vaccination 2nd vaccination 3rd vaccination T otal (%) (N=118) (N=114) (N=113) (N=345) Systemic Headache 4(3.4) 6(5.3) 3(2.6) 13(3.8) Dizziness 2(1.7) 3(2.6) 1(0.9) 6(1.7) Anorexia 1(0.9) 1(0.9) - 2(0.6) Nausea/ vomiting 1(0.9) 1(0.9) 1(0.9) 3(0.9) Fatigue 12(10.2) 8(7.0) 5(4.4) 25(7.3) Myalgia 19(16.1) 19(16.7) 15(14.2) 53(15.4) Arthralgia 2(1.7) - - 2(0.6) Fever 1(0.9) - - 1(0.3) Skin eruption 6(5.1) 1(0.9) 1(0.9) 8(2.3) Local Erythema 12(10.2) 9(7.9) 7(6.2) 28(8.1) Induration 4(3.4) 5(4.4) 5(4.4) 14(4.1) Pain/ tenderness 40(33.9) 20(17.5) 20(17.7) 80(23.2) T otal 53(44.9) 41(35.9) 35(31.0) 129(37.4)

5 Korean Journal of Medicine : Vol. 58, No. 1, 2000 Figure 3. Geometric mean titers of anti- HBs at 7-10 months after vaccination according to level of anti- HBs at 1 month after vaccination %, 15.4%.,,,,,,,,, %, %, %,,. B,,. B, - interferon, lamivudine B 5)., 5),. Krugman 6) B B Krugman 6,7) B B, 8-16)., 17-26), () H ansenula polymorpha B.,, 0, 1, 6 4). B 0, ), 85-95% anti- HBs (priming dose), 5-10% anti- HBs, anti- HBs 28). Anti- HBs 0, 1, 2, Engerix B 29). 0, 1, 2 HG- II, 93.8% 82.3% 10 miu/ml. Engerix B % 30) Asboe 31)83.1% HG- II. Engerix B0, 1, 6 0, 1, 2, 0, 1, 6 0, 1, 2 31) %,., anti- HBs 0, 1, 6 0, 1, 2 31,32) miu/ml 4)0, 1,

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