Observation on Clinic Effects of the Inactivated Healive® Hepatitis A Vaccin...
	[Original] Chinese J of Vaccines And Immunization August 2003, Vol,9 No.4 [Abstract] In order to understand the clinic effects of inactivated Healive® hepatitis A vaccine applied in adults, one hundred and ten healthy service staff aged from 18-35 years in a hotel were chosen, the 1.0ml of adult-applied inactivated hepatitis A vaccine was injected into the deltoid muscle of the upper arm, containing the inactivated hepatitis A antigen 500U, and the instant effect was observed in 30 minutes, and the local effects as well as the systematic effects were observed in 8, 24, 48 and 72 hours.
	Evaluation on Different Immunlzation schedules of Hepatitis A Vaccinc Healive
	[Original] Chinese J of Vaccines and Immunization August 2003, Vol.9 No.4 [Abstract] With a view to evaluate the immunogenicity of different immunization schedules of the Healive inactivated hepatitis A vaccine in five mountain area villagcs, 167 children aged 5-11 years old. seronegative for hepatitis A virus were randomly divided into five groups. Four groups administered 250U/dose vaccine according to 0、1,0、3,0、6 and0、12 schedules respectively. The control group administered Havrix 720EIU inactivated hepatitis A vaccine. The results showed that the positive seroconversion rate were 97.0% and 95.5%, the geometric mean titers (GMTs) were 355mIU/ml and 251 mIU/ml, respectively by two and four weeks after the primary dose in trial groups. The seroconversion rate were all 100%, the GMT were 417mIU/ml, 391mIU/ml and 361mIU/ml by 3、6 and 12 montbs after the primary dose, respectively. Seroconversion rate were all 100% by the booster dose after one month in four groups, GMT were 14,893mIU/ml(0.12),>5,963mIU/ml(0、6)>3, 265mIU/ml(0、3), and 1,973mIU/ml(0、1),it had significant statistical difference. In control group, seroconveraion rare were 71.0% and 71% 4 weeks and 6 months after the primary dose respectively and were 100% by one month after the booster dose;GMT were 158mIU/ml、152mIU/ml and 1,104mIU/ml respective. The GMT protective level was over 12 time after receiving one dose of Healive inactivated Hepatitis A vaccine. 0、1immunlzation schedule can be used to accelerate the immunity. 0、3,0、6 and0、12 schedules can be fiexibaly applied according to requirements of diferent population. The 0、12 months is the best schedule.
	The Study on Immunogenicity of Low-dose Inactivated Chinese Hepatitis A Vaccine
	[Original] Chinese J of Vaccines and Immunization Apr.2003 Vol.9 No.2 [Abstract] To define an optimal dosage and vaccination schedule of a new Chinese inactivated hepatitis A (HA) vaccine, 206 healthy children in mountain area villages of Hebei Province aged 5-15, negative for anti- HAV antibody were choose and were randomly divided into 6 groups. They were given 500U/does and 250U/does of vaccine by 0,1、0,3 and 0,5 month schedules. The local and systemic site effects were examined after primary and booster doses. The seroconversion rate and the geometric mean titer of anti-HA antibody were tested at 2,3,4 weeks and 3,4,6,7 months after vaccination. It showed that mild local and systemic reactions appeared transiently after vaccination. The positive seroconversion rates were 97.4% and 97.0% at 2 weeks after primary isosulation for 500U/dose and 250U/dose, respectively. Geometric mean antibody titers of 250U/dose ware 1 973mIU/ml, 3 265mIU/ml and 5 963mIU/ml are 0,1、0,3 and 0,6 month groups, respectively, among which, the 0,5 mouth groups developed the highest geometric mean antibody titer which had significant difference statistically. We concluded that the Chinese new inactivated hepatitis A vaccine is safe and effective, the 0.1 month schedule can be applied to special persons (such as travelers and workers to HAV prevalent area) and the 250U/dose with 0,6 month schedule is the optimal dosage and vaccination schedule for children.
	A comparative study on safety and immunogenicity of an inactivated hepatitis A v...
	[Original] Chinese J Exp Clin Virol, Dec.2002, Vol 16, No.4 [Abstract] Objective To evaluate safety and immunogenicity of inactivated hepatitis A vaccine in HBsAg carriers , HAV susceptible were enrolled in the study. The inactivated hepatitis A vaccine was produced by Tangshan Biogenetic Company. The dosage of the vaccine was 1000 U/Dosage and 500 U/Dosage. The vaccination schedule was six month apart from two injections. The serum anti-HAV level was detected with EU one month after first injection and at one and six month after the booster injection respectively. Results The anti-HAV appeared in all the children. One month after the booster injection, the serum anti-HAV level n children vaccinated 500 U/dosage was 4 684.9 miu and 4.535.6 mius respectively and in the children vaccinated 1000 U/Dosage. 5 399.8 MIU and 7 347.1 miu respectively. The anti-HAV level was not statistically different between the two groups of cildren. There was no adverse reaction after the vaccination. The anti-HAV level was still high one year after first injection. Conclusions The data indicated that the safety and immunogenicity of the domestic inactivated hepatitis A avaccine were excellent in both groups of children.
	The Study on Immunogenicity of the Low-dose Inactivated Domestic HAV Vaccine
	[Original] Chinese J of Vaccines and Immunization Dec. 2002,Vol.8 No.6 [Abstract] to evaluate the immunogenicity of the low-dose inactivated domestic HAV vaccine ( Healive), 65 HAV susceptible children, aged 4-10 years old, had been enrooled from two adjacent villages in Pignshan county, Hebei Province. The volunteers were randomly divided into two groups, 32 of them received three doses of 125 U/0.5 ml vaccine intra-muscularly at 0,1,6 month interval and 250 U/0.5 ml dose of vaccine in other 33 children for two injections of 0,6 month schedule. The anti-HAV seroconversion rates and there titers were screened by ELISA Kit at 1, 6, 7 months after primary injection and one month later after boosting. All serum samples conllected were kept at -20°C and resred by one lot ELISA Kit The results showed that in two groups, Healive inactivated HAV vaccine had no marked side effect neither locally nor systemically. The anti-HAV seroconversion rates increased to 100%, and the GMTs were 531 miu/ml, 301 mIU/ml one month after boosting, the GMTs were 3170 mIU/ml and 5963 mIU/ml for 125 U/0.5 ml and 250u/0.5 mul vaccine respectively. 125 u/0.5 ml Healive inactivated HAV vaccine is applicable for children, it also can be considered as a reference dose to prepare HAV, HBV combined vaccine.
	Study on the Safety and Immunogenicity of China Made Inactivated Hepatitis A Vac...
	[Original] Chin Prev Med, September 2002, Vol.3 No.3 [Abstract] Objective To investigate the safety and immunogenicity of a domestic inactivated hepatitis A vaccine when supplied to young children ( 1-4 years old). Methods Sixty-three susceptible healthy children whose age range from 1 to 4 were divided into two groups at random , and inculated with 500u/dose according to the 0,3 months schedule or 0,6 months schedule. The local and the systemic side effects were observed after vaccination, the seroconversion rate and geometric mean titers (GMT) of hepatitis A virus antibody were evaluated after primary immunization and the booster as well. HAV antibody were 85.7%, 88.5% and 83.8% corresponding to the 1, 3, 6 months after t he primary immunization and its GMTs were 182 miu/ml. 243 mju/ml. 280 miu/ml respectively. Both seroconversion rate for 0.3 months schedule and 0,6 months schedule were 100% 1 month after booster. While the anit-HAV GMTs for which were 2718 miu/ml and 4683 miu/ml respectively. Conclusion The domestic inactivated hepatitis A vaccine has satisfactory safety and immunogenicity when applied to young children; 0,6 months schedule was better than 0,3 months schedule.
	The Study on Immunogenicity, Safety and Vaccination Schedule of a New Inactivate...
	[Original] Chinese J of Vaccines and Immunization Feb. 2002,Vol.8 No.1 [Abstract] In order to evaluate the immunogenicity, safety and vaccination schedules of a new inactivated hepatitis A (HA) vaccine, 275 healthy children in mountain area villages of Hebei Province aged 5~15, negative both for HBsAg and anti-HAV antibody were randomly divided into 4 groups by village. They were given 1, 000 units (U)/dose and 500 units (U)/dose of vaccine by 0.3 and 0.6 month schedules. The local and systemic site effects were examined 30 min after vaccination and within 8h, 48h, 72h of vaccination respectively. The seroconversion rate and the geometric mean titer ( GMT) of anti-HA antibody were tested at months 1, 3, 4,6,7. The results showed that the local and systemic side effects of the new inactivated HA vaccine after first dose administration were 11.76% and 12.23% among children given 1, 000 U and 500 U groups were 938%, 9.6% and 174 miu/ml, 146 miu/ml respectively. One month after the second dose of vaccine, the positive seroconversion rates of all 4 groups were 100%, and the GMT raised to 7, 540 miu/ml in 1,000 U group and 4,535 miu/ml in 500 U group. The GMT in 500 U group with ,6 month schedule was more higher than that of 0,3 month schedule, 4,535 miu/ml versus 3.269 miu/ml the difference was statistically significant. We concluded that the new inactivated hepatitis A vaccine has good immunogenicity and safety, The 500 units/dose with 0,6 month schedule is better than 0,3 month schedule for children.
	Safety and immunogenicity of a new inactivated hepatitis A vaccine
	[Original] Chinese J Exp Clin Virol,December 2001,Vol 15,No.4 [Abstract] Objectives To evaluate the safety and immunogenicity of a new inactivated hepatitis A virus (HAV) vaccine. Methods In a randomized controlled trail thirty-one HAV-seronegative adults were enrolled and randomly assigned to either study group or control group. Subjects in the study group were gives 1,000 units of the new inactivated HAV vaccine, with a booster at 3 months. Subjects in the control group were given 720 ELISA units Havrix, produced by SmithKline Reecham Biologicals, with a subsequent dose at 3 months. Local and systematic reactions and serum response to the vaccines were compared between the two groups. Results Mild local reactions were noted in one subject from the study group and two from the control group after primary vaccination. Mild systematic reactions were reported in two subjects from each group after primary vaccination and in one subject from the study group after booster vaccination. Seroconversion rates were 94%、100%, and 100% in the study group at 1, 3 and 4 (1 month after booster) months respectively. The corresponding figures were 73%, 80% and 100% in the control group. Geometric mean antibody titers were 139.2mIU/ml, 137.7mIU/ml and 1066.7mIU/ml at 1,3,and 4 months, respectively, in the study group, and 104.3mIU/ml, 111.3mIU/ml and 760.7mIU/ml in the control group. Conclusion The new inactivated hepatitis A vaccine was safe and highly immunogenic.
	Experimental Study on Immunogenicity of Inactivated Hepatitis A Vaccine in Monke...
	[Original] Chin J Biologicals 1999,Vol.12.No.4 [Abstract] Inactivated hepatitis A(HA) vaccine was prepared by culturing the strain TZ84 of HA virus in 2BS cells, and the immunogenicity of it was studied in common marmosets and Macaca mulattas. The vaccine could also protect the monkeys from the challenge with strong virus strain (Luxing).It indicated that the inactivated HA vaccine had good immunological effect.