Nianmin Shi1, Yibin Zhang2, Huizhen Zheng3, Zhenggang Zhu4, Dingming Wang5, Sihai Li6, Yuhua Li7, Liqing Yang1, Junnan Zhang1, Yunhua Bai1, Qiang Lu1, Zheng Zhang1, Fengji Luo1, Chun Yu5, Li Li1. 1. a Chaoyang District Center for Disease Control and Prevention , Beijing , P.R. China. 2. b Liaoning Chengda biological Limited by Share Ltd , Shenyang , P.R. China. 3. c Guangdong Provincial Center for Disease Control and Prevention , Guangzhou , P.R. China. 4. d Wuhan City Center for Disease Control and Prevention , Wuhan , P.R. China. 5. e Guizhou Provincial Center for Disease Control and Prevention , Guiyang , P.R. China. 6. f Hunan Provincial Center for Disease Control and Prevention , Changsha , P.R. China. 7. g National Institutes for Food and Drug Control , Beijing , P.R. China.
Abstract
AIM: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. METHODS: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). RESULTS: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. CONCLUSIONS: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.
AIM: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. METHODS: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). RESULTS: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. CONCLUSIONS: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.
Authors: Charles E Rupprecht; Deborah Briggs; Catherine M Brown; Richard Franka; Samuel L Katz; Harry D Kerr; Susan M Lett; Robin Levis; Martin I Meltzer; William Schaffner; Paul R Cieslak Journal: MMWR Recomm Rep Date: 2010-03-19